Effects of Low-calorie Sweetened Beverage Restriction in Youth With Type 1 Diabetes
Phase: NA
Conditions: Type 1 Diabetes
Sponsor: Allison Sylvetsky (Meni)

 
Study Title: Effects of Low-calorie Sweetened Beverage Restriction in 
Youth with Type 1 Diabetes 
 
NCT04385888 
 
Protocol Version: March 25, 2021 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
Table of Contents 
SECTION 1 KEY ROLES  
SECTION 2 INTRODUCTION, BACKGROUND INFORMATION AND SCIENTIFIC 
RATIONALE 
 
2.1 
Background Information and Relevant Literature 
 
2.2 
Scientific Rationale  
 
2.3 
Potential Risks 
 
 
2.4 
Potential Benefits 
SECTION 3 OBJECTIVES AND ENDPOINTS  
 
3.1 
Primary Objective(s) 
 
 
3.2 
Secondary Objective(s) 
 
 
3.3 
Primary Outcome Measure(s) 
 
 
3.4 
Secondary Outcome Measure(s) 
SECTION 4 STUDY DESIGN 
SECTION 5 STUDY ENROLLMENT AND WITHDRAWAL 
 
5.1 
Study Population, Recruitment Retention 
 
 
5.2 
Inclusion Criteria 
 
5.3 
Exclusion Criteria 
 
5.4 
Inclusion of Children 
 
 
 
5.5 
Recruitment 
 
5.6 
Retention 
 
5.7 
End of Participation Criteria and Procedure 
 
SECTION 6 STUDY PROCEDURES 
 
6.1 
Informed Consent/Assent  
 
6.2 
Screening Process 

 
 
6.3 
Study Interventions and Follow-Up 
 
6.4 
Description of Study Procedures/Evaluations 
 
6.5 
Study Team Training and Intervention Reliability 
SECTION 7 STATISTICAL CONSIDERATIONS AND ANALYSIS 
SECTION 8 DATA QUALITY AND OVERSIGHT 
 
8.1 
Study Team Quality Assurance and Control 
SECTION 9 ETHICAL CONSIDERATIONS 
 
 
9.1 
Ethical Standard 
 
9.2 
Institutional Review Board (IRB)  
 
9.3 
Maintaining Subject Privacy 
 
9.4 
Maintaining Study Data Confidentiality 
 
9.5 
Certificate of Confidentiality 
 
9.6 
Study Support and Conflicts of Interest 
SECTION 10 DATA HANDLING AND RECORD KEEPING 
 
10.1 Data Management Responsibilities 
 
10.2 Data Capture Methods 
 
 
10.3 Study Record Retention Policy 
SECTION 11 PUBLICATION POLICY 
 
SECTION 12 APPENDIX 
 
 
 
 
 
 
 
 

 
List of Abbreviations 
 
ACE-K 
Acesulfame-potassium 
GCP 
Good Clinical Practice 
HIPAA 
Health Insurance Portability and Accountability Act 
IRB 
Institutional Review Board 
LAR 
Legally Authorized Representative 
LCSB 
Low-calorie sweetened beverage 
LCS 
Low-calorie sweetener 
OHRP 
Office for Human Research Protections 
PI 
Principal Investigator 
QA 
Quality Assurance 
QC 
Quality Control 
SOP 
Standard Operating Procedure 
CTSI 
Clinical and Translational Science Institute 
COI 
Conflicts of Interest 
CITI 
Collaborative Institutional Training Initiative 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
Protocol Summary 
 
Title:  
 
 
Brief Summary: 
Effects of Low-calorie Sweetened Beverage Restriction in 
Youth with Type 1 Diabetes 
 
This study will investigate whether low-calorie sweetened 
beverages (LCSBs) are helpful or harmful for preventing 
diabetes complications among children with Type 1 
Diabetes (T1D). 
Study Population:  
The study population will consist of children (ages 5-14 
years) with T1D, who report consumption of ≥ 12 oz. of a 
LCSB with sucralose (+/- ace-K) or aspartame+ace-K per 
day and their parent/guardian. The study population will 
also consist of up to 40 additional parent/guardians of 
children 5-14 with type 1 diabetes, who will participate in 
the qualitative interview about the impacts of the COVID-19 
pandemic on their child’s type 1 diabetes management.  
Study Site:  
 
 
Number of 
Participants: 
Sheik Zayed Campus—Childhood and Adolescent 
Diabetes Program at Children’s National. 
 
 
60 Children (120 participants including parent/guardian) for 
RCT; up to 40 additional parents for COVID-19 interviews 
Accrual Ceiling: 
 
Study Duration: 
60 children (120 parents including parent/guardian) for 
RCT, 40 parents for COVID-19 interviews 
 
2 years 
Subject Duration:  
The total duration of subject participation for the RCT will 
be 14 weeks. The total duration of participation for the 
COVID-19 interviews will be approximately 30-45 minutes 
on a single day.  
Objective(s):  
 
 
 
Methodology: 
To conduct a 12-week pilot intervention (involving a two-
week run-in period prior to the intervention) to investigate 
the effects of LCSB consumption on children with T1D. To 
better understand the impacts of the COVID-19 pandemic 
on management of type 1 diabetes in childhood.  
 
 
Pilot intervention study involving replacement of child 
LCSB consumption with unsweetened beverages (e.g. still 
or sparkling water) compared to control (continuation of 

 
 
 
 
usual LCSB consumption) and assessing glycemic 
variability using continuous glucose monitoring, as well as 
body composition and inflammatory cytokines before and 
after the intervention. Conduct of qualitative interviews 
about impacts of the COVID-19 pandemic on T1D 
management in a separate sample of parents (some of 
whom will have a child participating in the RCT).  
Outcome Measures: 
HbA1c, CRP, IL-6, TNF-α, LDL, HDL, triglycerides, and 
free fatty acids (FFA) measured in blood samples. 
Sucralose and ace-K concentrations in biological fluids, 
including urine. Visceral fat area from DXA or BodPod. 
Continuous blood glucose to assess glycemic variability, 
photo-assisted food records to assess adherence to LCSB 
restriction and any changes in diet throughout study, 
beverage log to assess adherence, satisfaction survey, 
Diabetes Self-Care Inventory (SCI), physical activity 
questionnaire (PROMIS), COVID-19 diabetes 
management questionnaire, Eating Attitudes (EAT) 
questionnaire, and an in-depth interview. Additional, in-
depth interview about COVID-19 impacts on T1D 
management (for those who screen ineligible for full study 
andthose who participate in DRINK and are interested in 
also participating in this additional interview) 
Study Intervention/ 
Procedures: 
 
 
 
Statistical Analysis: 
 
Children will be randomly assigned to either replace their 
LCSB consumption with still or seltzer water or to continue 
their usual LCSB consumption for 12 weeks. Parents who 
participate in the COVID-19 interviews will undergo a brief 
qualitative interview with a trained interviewer.  
 
 
Univariate analyses and one-way ANOVA will be used to 
assess group differences in glycemic variability and other 
metabolic outcomes pre/post intervention. Bivariate 
associations will be examined using odds ratios, chi-
squared, boxplots, mean differences, and ANOVA, as 
appropriate.  Qualitative data collected during interviews 
will be transcribed verbatim and thematically coded.  

 
 
SECTION 1 Key Roles 
Principal Investigator: Dr. Randi Streisand 
Address: 111 Michigan Ave NW #1200, Washington, DC 20310 
Phone: 202-476-2730 
Email: RSTREIS@childrensnational.org 
 
SECTION 2 Introduction, Background Information, and Scientific Rationale 
 
2.1 
Background Information and Relevant Literature 
Type 1 diabetes (T1D) is a lifelong metabolic disorder that affects 1 out of every 500 
American children annually. Children diagnosed with T1D before the age of ten are at 
11 times higher risk of cardiovascular disease, six times higher risk of stroke, and most 
notably, 31 times higher risk of coronary heart disease and myocardial infarction 
compared to similar-aged children without T1D. Furthermore, cardiometabolic 
perturbations, including abnormalities in circulating inflammatory cytokines, are 
observable in children with T1D despite their young age. As demonstrated in the 
SEARCH cohort, a common strategy for T1D management and prevention of 
cardiovascular complications is replacement of added sugars with low-calorie 
sweeteners (LCSs), which provide sweetness without calories and at a reduced 
glycemic load. However, effects of LCSs on glycemic control and cardiometabolic health 
are controversial. In cellular models, incubation of mesenchymal stem cells with 
sucralose at physiologic concentrations upregulates expression of genes involved in 
adipogenesis and inflammation. In rodents, prolonged sucralose consumption induces 
glucose intolerance, disturbs the gut microbiota, increases visceral adiposity, and 
promotes metabolic abnormalities. And, in humans, prospective cohort studies in adults 
without diabetes consistently report positive associations between LCS consumption, 
weight, metabolic syndrome, and cardiovascular disease (CVD). Furthermore, acute 
studies of LCS’s effects in adults demonstrate elevated post-prandial glucose and 
insulin responses when LCSs are ingested prior to an oral glucose tolerance test 
(OGTT). Meanwhile, little is known about effects of LCSs in children, and low-calorie 
sweetened beverage (LCSB) consumption specifically in children with T1D is severely 
understudied. This is particularly concerning because hyperglycemia and inflammation 
play a key role in accelerated CVD onset in T1D and visceral adiposity is strongly linked 
to hypertension and dyslipidemia, further promoting CVD development. In this study, 
children with T1D are randomly assigned to either replace LCSBs with still or seltzer 
water for 12 weeks or continue usual LCSB consumption (control). 
 
2.2 
Scientific Rationale 
The scientific premise of this proposal is that while use of LCSs in place of added 
sugars reduces the calorie and sugar content of foods and beverages, this replacement 
may not improve and may even paradoxically worsen glycemic variability and 
exacerbate cardiometabolic health among already at-risk children with T1D. Given that 
LCSB use, particularly LCSBs with sucralose or aspartame+acesulfame-potassium 
(ace-K), is widespread in children with T1D and even modest metabolic perturbations 
predict future CVD onset, there is tremendous significance in investigating the extent to 

 
which replacement of usual LCSB consumption with still or seltzer water (hereafter 
referred to as LCS restriction) improves glycemic variability, visceral adiposity, lipid 
profiles, inflammation, and other CVD risk factors. The scientific premise for conducting 
qualitative interviews about the impacts of the COVID-19 pandemic on children’s type 1 
diabetes management is that this has not been in this population to date and has critical 
implications for the clinical care of children with type 1 diabetes.   
 
Hypothesis 
We hypothesize that participants will adhere to 12 weeks of LCSB restriction and will 
find the intervention acceptable. We also anticipate that 12 weeks will be enough time to 
observe changes in study outcomes. We hypothesize that an increase in the time in 
target glycemic range, a decrease in visceral adiposity and inflammatory cytokines, and 
an improvement in lipid profiles will be observed in those randomized to LCSB 
restriction vs. control. 
 
Study population 
The study population will consist of 60 children with T1D, ages 5-14 years old (and their 
parent(s)/guardian(s), n=120 including parent/guardian and child), who report habitual 
consumption of greater than or equal to 12 ounces of LCSBs with sucralose (+/- ace-K) 
or aspartame+ace-K per day. We will also a separate sample of up to 40 parents of 
children 5-14 years of age with type 1 diabetes to participate in interviews about the 
impacts of the COVID-19 pandemic on their child’s type 1 diabetes management.  
 
Study Interventions 
This study includes an intervention where children are randomly assigned to either 
replace LCSBs with still or seltzer water or to continue usual LCSB consumption 
(control) in order to determine whether LCSB restriction impacts glycemic variaiblity and 
cardiometabolic risk factors in 5-14-year-old children with T1D. 
 
2.3 
Potential Risks 
It is possible that other participants and individuals external to the study may find out 
that a participant took part in the research, in which case, information derived may be 
conveyed to others external to the group.  
 
Blood Draws: Although blood draws are a standard medical procedure, there is a risk of 
discomfort at the site of the needle entry or bruising at the site. There is also a remote 
risk of fainting or local infection associated with drawing blood. To address this, only 
skilled and well-trained phlebotomists will carry out these procedures. 
 
Continuous glucose monitoring (CGM): The use of CGM for measurement of glycemic 
variability and ‘time in range’ may be challenging for some children and their parents. 
Although CGM is commonly used in children with T1D, some children may be fearful of 
the insertion or embarrassed to share their blood glucose levels. We will work with the 
child and parent to ensure the child is comfortable. We will also discontinue CGM if this 
becomes painful or problematic to the child or parent.  
 

 
Dual energy X-ray absorptiometry (DXA): This instrument is used to measure body fat 
using low dose x-ray. This scan does give a small amount of radiation. Using the 
standard way of describing radiation exposure, subjects will receive an effective dose of 
less than one thousandth of one rem from each DXA scan. By comparison, the average 
person in the United States receives approximately this much radiation every day from 
natural background sources, such as the sun and from radioactive materials that are 
found naturally in the earth’s air and soil. 
  
Spot urine sample: We are not aware of any known risks from providing a spot urine 
sample. However, collecting the sample may be uncomfortable, burdensome, or 
embarrassing for some individuals. We have minimized this risk by having participants 
collect the urine sample in a private space and de-identifying the data collected to 
ensure that urine samples are not directly linked to the subject’s identity. 
 
BodPod: Children may experience ear popping while in the BodPod and some children 
may also feel claustrophobic or be otherwise nervous while in the BodPod. We have 
minimized this risk by excluding any child with acute illness from study participation 
(including those with ear or sinus infections) and working with the child and parent to 
ensure the child is comfortable prior to the BodPod. Furthermore, only trained staff in 
the Clinical Research Unit will conduct the BodPod assessments.  
 
Qualitative interviews: Completing interviews may be uncomfortable, burdensome, or 
embarrassing for some individuals. We have minimized this risk by de-identifying the 
data collected to ensure that responses to the questions are not directly linked to the 
subject’s identity.  Participants will not have to answer questions if they do not wish to 
do so. 
 
Food Records: We are not aware of any known risks from completing food records. 
However, completing food records may be uncomfortable, burdensome, or 
embarrassing for some individuals. We have minimized this risk by de-identifying the 
data collected to ensure that beverage logs are not directly linked to the subject’s 
identity. 
 
Questionnaires: We are not aware of any known risks from completing questionnaires. 
However, completing the EAT assessment, satisfaction survey, PROMIS physical 
activity questionnaire, or COVID-19 diabetes management questionnaire may be 
uncomfortable, burdensome, or embarrassing for some individuals. We have minimized 
this risk by de-identifying the data collected to ensure that questionnaire responses are 
not directly linked to the subject’s identity. 
 
Beverage logs: We are not aware of any known risks from completing beverage logs. 
However, completing beverage logs may be uncomfortable, burdensome, or 
embarrassing for some individuals. We have minimized this risk by asking participants 
to submit beverage logs via text message or email and de-identifying the data collected 
to ensure that beverage logs are not directly linked to the subject’s identity. 
 

 
We do not anticipate any long-term risks to participants from participation in this study. 
However, there is always the possibility of risks currently unknown and the potential 
breach of privacy. To minimize the risk of breach of confidentiality, all data will be 
immediately de-identified following collection. Data will initially be associated with an 
alphanumeric code and a copy of the key to this code will be kept in a locked filing 
cabinet. All computers used for analysis of this data are password protected and kept in 
locked offices and/or laboratories. 
 
All participants will be made aware that study participation is entirely voluntary and will 
have the opportunity to choose not to participate. Subjects will have the opportunity to 
drop out of the study at any time. The potential benefits outweigh the risks because the 
study is minimal risk and procedures do not exceed the risks encountered in routine 
medical procedures. Furthermore, what we learn about LCSB consumption among 
children with T1D will be critical to informing the design of future interventions. 
 
2.4 
Potential Benefits 
There are no direct benefits to the participants of the study. However, the potential 
public health benefits of this study are of substantial magnitude. A common strategy for 
diabetes management and prevention of cardiovascular complications is replacement of 
added sugars with LCSs, which provide sweetness at a reduced glycemic load. 
However, the effects of LCS on glycemic control and cardiometabolic health are 
controversial and little is known about the effects of LCS consumption in youth, 
specifically in those with T1D.  
 
This study will determine the effect of chronic LCSB use among children with T1D on 
glycemic control and cardiometabolic health. Given that modest metabolic perturbations 
predict future CVD onset, there is tremendous significance in investigating the extent to 
which replacement of LCSB consumption improves glycemia, visceral adiposity, lipid 
profiles, inflammation, and other CVD risk factors. 
 
SECTION 3 Objectives and Endpoints 
 
3.1 
Primary Objective(s) 
To examine the effects of replacement of usual LCSB consumption with unsweetened 
still or seltzer water for 12 weeks on glycemic variability using continuous glucose 
monitoring (CGM) compared to control (continuation of usual LCSB consumption).  
 
3.2 
Secondary Objective(s) 
To examine the effects of replacement of usual LCSB consumption with unsweetened 
still or seltzer water for 12 weeks on visceral adiposity, lipid profiles, and systemic 
inflammation compared to control (continuation of usual LCSB consumption). To 
examine the impacts of the COVID-19 pandemic on pediatric type 1 diabetes 
management.  
 
3.3 
Primary Outcome Measure(s)  
Glycemic variability and HbA1c 

 
 
3.4 
Secondary Outcome Measure(s) 
Visceral adiposity, lipid profiles, and systemic inflammation, impacts of COVID-19 
pandemic on type 1 diabetes management from qualitative interviews 
 
SECTION 4 STUDY DESIGN 
 
Eligible volunteers for the RCT will be identified prior to or during their routine clinical 
visit in the Childhood and Adolescent Diabetes Program (CADP) at Children’s National 
Hospital and will be provided with study information by their physician or a member of 
the research team either via mail (if prior to visit), email, phone and/or or in person 
(recruitment letter and flyer enclosed), or will be reached out to via social media and 
word of mouth. The parent will complete a brief phone screening to determine initial 
study eligibility.  If their child is eligible for the RCT, they will be scheduled for a 
screening/enrollment visit via Zoom Telehealth and will also have the option of 
participating in a separate interview about the impacts of the COVID-19 pandemic on 
their child’s diabetes management (separate consent form, survey, and interview guide 
enclosed).   
 
If their child is ineligible for the RCT, the parent will be invited to participate in the 
qualitative interview about impacts of the COVID-19 pandemic on T1D management, 
which will be scheduled at a time convenient for the parent and will be administered 
remotely via Zoom Telehealth. All parents of children 5-14 years old with T1D, and 
whose child has had T1D for at least one year, will be eligible to participate in the Zoom 
Telehealth interview. The interview will be conducted at a date/time convenient for the 
parent and will take place remotely via Zoom Telehealth. Participation in the interview 
about impacts of the COVID-19 pandemic on diabetes management will involve 1) 
providing informed consent via Redcap 2) answering questions about the parent's sex 
and race/ethnicity and the child's age and duration of diabetes, 3) answering brief 
survey questions about diabetes management during the COVID-19 pandemic and 
whether they are vaccinated (enclosed), and 4) participating in a 20-30 qualitative 
interview about the impacts of COVID-19 on their child's diabetes management, 
conducted by Dr. Meni. 
 
For those determined to be initially eligible for the RCT, the screening/enrollment 
procedures will proceed as follows: after obtaining informed consent (from the 
parent/guardian(s)) and assent (from the child) the research team will guide the 
participant through the SCI, PROMIS physical activity, COVID-19 diabetes management 
questionnaire, and EAT assessments, and a Dexcom™ sensor will be placed on the 
child’s abdomen. The sensor will remain in place for 7-10 days. The parent will then 
replace the sensor (provided by study team) to allow for 14 days of wear-time, until 
removal at the baseline visit. Participants will be randomly placed in one of two groups. 
If the participant is already using CGM, they will have the option to have this first study 
meeting remotely via Zoom Telehealth. If the participant attends the visit via Zoom 
Telehealth, the participant and their parent will provide informed consent using the 
recently approved RedCap e-consent platform.  At the end of the screening, participants 

 
will be provided with low-calorie sweetened beverages, matched as closely as possible 
to the brands that they usually consume, to encourage continuation of usual beverage 
intake between until the baseline visit. During the week prior to the baseline visit (Week 
0), they will be instructed to continue their usual dietary habits and complete an online 
photo-assisted 7-day food record (instructions enclosed), with parental assistance. 
While we recognize that parents are unlikely to accurately report all of their child’s 
intake because they are not always with them (e.g., during school), dietary data for 
children under 14 years are most accurately reported when provided by the parent or 
child and parent combined.  
 
Eligible participants will be scheduled for a baseline visit in the Clinical Research Unit 
(CRU) at CNMC. One group will replace their usual LCSB consumption with 
unsweetened still or seltzer water (LCSB restriction) for 12 weeks. The other group will 
continue their usual LCSB use (control) for 12 weeks. The baseline visit will take place 
in the CRU, where height and weight will be measured, a spot urine sample will be 
collected (for measurements of sucralose and ace-k concentrations), and a blood draw 
will be performed. Participants will be provided with a copy of their laboratory (blood) 
results from the baseline visit and will be encouraged to discuss them with their 
physician. Participants will have the DEXCOM G6™ sensor removed and CGM data 
downloaded. In a subset of participants (n=30), a DXA scan or BodPod will also be 
performed, as R21 budget constraints preclude DXA or BodPod on all 60 subjects.  
 
Subjects will be randomized to either: 1) LCSB restriction or 2) continuation of usual 
LCSB intake (control). All participants (both LCSB restriction group and control group) 
and their parent(s) or guardian(s) will undergo a brief, 20-minute orientation where the 
PI and study dietitian will provide an introduction to the study, instructions on completing 
food records, education on CGM and placement of the DEXCOM G6™ sensor, and 
counseling on healthy eating strategies. For children not already using CGM, parents 
will also receive 3 additional sensors (replacement in Week 1, placement in Week 11, 
and replacement in Week 12 for 14 days wear time), written instructions and additional 
resources (YouTube video) for placing (or replacing) the glucose sensors. Participants 
in the intervention group will be counseled on avoiding LCSBs. Participants and their 
parent will also be given a brochure (enclosed) on avoiding LCSs to take home which 
will include a list of specific foods and beverages containing LCSs to avoid during the 
study. Parents will also receive information on strategies to encourage study adherence 
(enclosed). Participants in the control group will be counseled on healthy eating as 
those in the intervention group (in accordance with standard dietary guidance for T1D 
management), with the exception of information and resources for avoiding LCSBs.  
Participants in both groups will be provided with sample beverages (LCSBs or 
unsweetened still and seltzer water), per their randomization.  
 
In both groups, text messages will be sent to parents 3 times per week with reminders 
that their child should avoid LCSBs or continue usual intake, per randomization. 
Adherence will be monitored through daily text message beverage logs completed by 
the parent and photo-assisted food records with parent assistance in Weeks 0, 6, and 
12, as well as spot-urine samples (to measure sucralose and ace-K concentrations 

 
(baseline, week 6, and follow-up visit). During Week 6, participants and their parent will 
attend a mid-intervention telemedicine booster visit, during which the PI and/or study 
RA will reinforce the intervention and remind participants to mail back a spot urine 
sample using materials provided by the study team at baseline. Participants will be 
reminded of the study instructions, including the importance of inserting the DEXCOM 
G6 sensor (provided by study team) at the beginning of Week 11. Parents will receive a 
phone reminder to insert the sensor at the end of Week 10 and a second call early in 
Week 11 to ensure that the sensor has been placed and will be replaced after 7-10 days 
to allow for 14 days of wear time prior to the follow-up visit. Depending on 
randomization assignment, guidance to avoid LCSBs or continue usual diet will be 
reinforced. Participants will be reminded to store their CGM data for weeks 11 and 12. 
All participants and their parent will have the opportunity to chat in real-time with the 
study team about questions or concerns.  
 
At the end of Week 12, participants and their parent will return for follow-up in the CRU. 
Participants will have their DEXCOM G6™ sensor removed and CGM data downloaded 
using DEXCOM Clarity™ software. Height and weight will be measured and a second 
blood draw performed. Participants will again be provided with a copy of their laboratory 
(blood) results and encouraged to discuss them with their physician. Those who had an 
DXA at the baseline visit (n=30) will undergo a second DXA or BodPod scan after which 
these participants and their parent will receive a consultation on the DXA or BodPod 
results. Those randomized to the intervention will be purposefully sampled and asked to 
complete a ~20-minute qualitative interview and ~5 minute satisfaction survey, together 
with their parent, about their study experience and the challenges of LCSB restriction. 
This will allow us to collect information from individuals with a range of perspectives and 
varying degrees of intervention adherence. Sampling will continue until saturation of 
ideas is reached or until all subjects in the intervention group are invited to be 
interviewed.  
 
SECTION 5 STUDY ENROLLMENT AND WITHDRAWAL 
 
5.1 
Study Population, Recruitment and Retention 
Potentially eligible participants will be identified through CNMC’s medical records prior 
to routine clinic visits. The study will also be advertised to T1D patients in the CADP 
through a trained research assistant (RA) in clinic waiting rooms at the time of their 
routine clinic visits. If a participant expresses interest and meets eligibility criteria, a 
screening visit will be scheduled for directly before or after the patient’s routinely 
scheduled clinic visit. Participants will also be recruited via word of mouth and social 
media, recruiting children with T1D and their parents willing to travel to Children’s 
National for the in person components.  During the screening visit the child and their 
parent/guardian (referred to as parent) will complete a LCSB screener questionnaire 
and brief eligibility checklist, including the Eating Attitude Test (EAT) administered by 
the RA to determine initial eligibility (which will be confirmed by Dr. Cogen). Eligible 
participants and their parent will provide assent and consent, respectively. 
 

 
To encourage adherence and retention, we will provide $340 for study participation (this 
includes $120 for the baseline visit, $120 for the follow-up visit, $30 for booster session, 
$40 for 4 food records, $30 for the screening visit). The subset of participants who 
undergo DXA or BodPod will receive an additional $50 per visit, for a total of up to $440 
compensation for study participation. Additional compensation will be provided to cover 
the cost of parking (parking voucher) or transportation (equivalent up to $10) to 
Children’s for study visits. We will also encourage retention by maintaining regular 
contact with study participants through text message/email reminders and the 6-week 
telemedicine booster session.  
 
5.2 
Inclusion Criteria (RCT) 
• Child is between 5 to 14 years old 
• Child consumes ≥ 12 oz. of a LCSB with sucralose (+/- ace-K) or aspartame+ace-
K per day 
• Child has had a diagnosis of T1D for at least one year 
• Parent/guardian has reliable phone and internet access 
• Parent/guardian and child both speak English 
 
Inclusion Criteria (COVID-19 interviews) 
 
• Parent of child with T1D between 5 to 14 years old 
• Parent of child who has had a diagnosis of T1D for at least one year 
• Parent/guardian has reliable phone and internet access 
• Parent/guardian speaks English fluently  
• Parent of child enrolled in the Childhood and Adolescent Diabetes Program 
(CADP) at Children’s National 
 
 
5.3 
Exclusion Criteria (RCT) 
• Child consumes foods with low-calorie sweeteners (e.g., sugar-free ice cream, 
light yogurt, sugar-free oatmeal) more than 3 times per week 
• Child consumes condiments with low-calorie sweeteners (e.g., sugar-free 
pancake syrup, sugar-free jam, reduced sugar ketchup) more than 3 times per 
week 
• Child has a poorly managed chronic disease other than T1D, acute illness, current 
or prior eating disorder as assessed by the EAT or is taking medications other 
than insulin 
 
Exclusion Criteria (COVID-19 interviews) 
 
• Not applicable. 
 
5.4 
Inclusion of Children 
We will study children 5-14 years, rather than older adolescents, because children of 
this age are more often monitored by their parents than older children, enabling us to 
more effectively engage parents to maximize intervention adherence. Children 4 years 

 
and younger will be excluded because LCSB consumption is relatively low in this age 
group.  
 
5.5 
Recruitment 
The study (both the RCT and the COVID-19 interviews) will be advertised to the clinic 
patient populations and their parents through on-site recruitment in clinic waiting rooms 
and through searching CNMC medical records prior to their routine clinic visits, as well 
as via social media, list servs, and word of mouth. Potentially eligible patients will be 
provided with study information by in-person, via email, postal mail or by phone 
(recruitment letter for RCT enclosed).  
 
For the COVID-19 interviews, if a parent expresses interest and meets eligibility criteria, 
they will be scheduled for a Zoom Telehealth interview at a day/time convenient for 
them.  
 
For the RCT, if a participant expresses interest and meets initial eligibility criteria 
(assessed in person or via phone), a screening visit will be scheduled immediately 
before or after the patient’s upcoming clinic visit to ensure minimal disturbance to clinic 
flow. If the patient is already using CGM, the participant will have the option to complete 
this screening visit remotely via Zoom Telehealth rather than in person. Given the large 
volume of children served by the participating sites, we do not anticipate any problems 
recruiting and retaining a diverse sample of children. If the potential participant has 
questions that the research assistant (RA)/clinical study coordinator (CRC) cannot 
answer, the RA/CRC will immediately contact Dr. Streisand.  
 
5.6 
Retention 
We will maximize retention by maintaining regular contact with RCT participants through 
text message/email reminders throughout the study. This will help us to develop rapport 
with the subjects. In addition, we will provide a total of $340 for participating in the 
study. The subset of participants who undergo DXA or BodPod will receive an additional 
$50 per visit, $440 total. Compensation will be provided using the Forte payment 
system (analogous to ClinCard) at GW. For parents who participate in the COVID-19 
interviews, compensation of $50 will be provided and will be provided as a gift card.  
 
5.7 
End of Participation Criteria and Procedures 
Participants are free to withdraw from participation in the study at any time upon 
request. An investigator may terminate study participation if:  
• The participant meets an exclusion criterion (either newly developed or not 
previously recognized) that precludes further study participation. 
• The participant is unwilling or unable to comply with the study procedures. 
 
This study may be temporarily suspended or prematurely terminated if there is sufficient 
reasonable cause. Written notification documenting the reason for study suspension or 
termination will be provided by the suspending or terminating party to participants, site 
investigators, the funding agency and regulatory authorities (e.g., OHRP). If the study is 

 
prematurely terminated or suspended, the PI will promptly inform the IRB and will 
provide the reason(s) for the termination or suspension. 
 
Circumstances that may warrant study termination or suspension include, but are not 
limited to: 
• Determination of unexpected, significant, or unacceptable risk to participants 
• Insufficient study team or site participant compliance to protocol requirements 
• Data that are not sufficiently complete and/or evaluable 
• Determination of futility 
 
The study may resume once any concerns about safety, protocol compliance, data 
quality or funding are addressed and satisfy the sponsor, IRB and OHRP. 
 
  
SECTION 6 STUDY PROCEDURES 
 
6.1 
Informed Consent/Assent 
Informed consent is a process that is initiated prior to the individual’s agreeing to 
participate in the study. It continues throughout the individual’s study participation. 
Consent and assent forms will be IRB-approved. The parent and participant will be 
asked to read and review the consent and assent document(s), respectively. Extensive 
discussion of risks and possible benefits of participation will be provided to the 
participants and their families. The investigator will explain the research study to the 
participant and answer any questions that may arise. All participants will receive a 
verbal lay explanation of the purposes, procedures, and potential risks of the study and 
of their rights as research participants. Participants and their parent/guardian will have 
the opportunity to carefully review the consent and assent form and to ask questions 
prior to signing. Documentation of parent informed consent (written or using RedCap e-
consent platform) and child assent is required for all participants prior to enrolling in the 
study of undergoing any procedures.  
 
The parent and their child will sign the informed consent and assent, respectively, prior 
to beginning any study procedures. The participants may withdraw consent/assent at 
any time throughout the course of the study. A copy of the informed consent 
document(s) will be given to the participant/LAR for their records. The rights and welfare 
of the participants will be protected by emphasizing that the quality of their medical care 
will not be adversely affected if they decline to participate in this study. 
 
If the participant has questions that the research assistant (RA)/clinical study 
coordinator (CRC) cannot answer, the RA/CRC will immediately contact Dr. Streisand to 
provide clarification. The above described process for obtaining informed consent will 
also apply for obtaining consent from parents participating in the separate, qualitative 
interview about impacts of the COVID-19 pandemic on T1D management. No assent is 
needed for the qualitative interviews pertaining to impacts of the COVID-19 pandemic 
on T1D management because only the parent will participate.  
 

 
 
6.2 
Screening Process 
Subjects will be screened in-person or via Zoom Telehealth or phone before or after 
patient’s upcoming clinic visit. Participants will be asked about each of the 
inclusion/exclusion criteria using the eligibility screener questionnaire, and the EAT, and 
will be asked to answer a brief prompt (“The COVID-19 pandemic has impacted 
management of my/my child’s type 1 diabetes by….”) about the impact of the COVID-19 
pandemic on diabetes management. Any eligible participant will be invited to participate 
until our total sample size is reached.  
 
6.3 
Study Interventions and Follow-Up 
At the end of Week 12, participants and their parent will return for follow-up in the CRU. 
Participants will have their DEXCOM G6™ sensor removed and CGM data downloaded 
using DEXCOM Clarity™ software. Height and weight will be measured and another 
urine sample and blood draw performed. Those who had a DXA scan or BodPod at the 
baseline visit (n=30) will undergo a second DXA scan or BodPod, after which these 
participants and their parent will receive a consultation on the results. Those 
randomized to the intervention will be purposefully sampled and asked to complete a 
~20-minute qualitative interview and ~5 minute satisfaction survey, together with their 
parent, about their study experience and the challenges of LCSB restriction. This will 
allow us to collect information from individuals with a range of perspectives and varying 
degrees of intervention adherence. Sampling will continue until saturation of ideas is 
reached or until all subjects in the intervention group are invited to be interviewed. 
There is no follow-up for participants in the COVID-19 interviews.  
 
6.4 
Description of Study Procedures/Evaluations  
We propose a two-arm randomized controlled trial (RCT) during which 60 children with 
T1D will either replace usual LCSB consumption with unsweetened still or seltzer water 
(LCSB restriction) or continue usual LCSB use (control) for 12 weeks. This will provide 
ample time to evaluate intervention feasibility and acceptability, while enabling us to 
generate preliminary evidence of whether LCSB restriction may improve 
cardiometabolic health. 
 
Eligible participants will be scheduled for a baseline visit in the Clinical Research Unit 
(CRU) at CNMC. During the week prior, they will be instructed to continue usual dietary 
habits and complete an online photo-assisted 7-day food record, with parental 
assistance. While we recognize that parents are unlikely to accurately report all of their 
child’s intake because they are not always with them (e.g., during school), dietary data 
for children under 14 years are most accurately reported when provided by the parent or 
child and parent combined.  
 
The baseline visit will take place in the CRU, where height and weight will be measured, 
a spot urine sample will be collected, and a blood draw will be performed. Participants 
will have the DEXCOM G6™ sensor removed and their CGM data downloaded. In a 
subset of participants (n=30) a DXA scan or BodPod will also be performed, as R21 
budget constraints preclude DXA or BodPod on all 60 subjects. Subjects will be 

 
randomized (Section C.6) to 1) LCSB restriction or 2) usual LCSB intake (control). All 
participants (both control and LCSB restriction) and their parent will undergo a brief, 20-
minute orientation where the PI and study dietitian will provide an introduction to the 
study, instructions on completing food records, additional education on CGM and 
placement of the DEXCOM G6™ sensor, and counseling on healthy eating strategies. 
Parents will also receive 3 additional sensors (replacement in Week 1, placement in 
Week 11, and replacement in Week 12 for 14 days wear time), written instructions and 
additional resources (YouTube video) for placing (or replacing) the glucose sensors. 
Those in both groups will be given sample study beverages at baseline (several 
varieties of still and seltzer water for intervention group or LCSBs matched as possible 
to those typically consumed in the control group) to encourage adherence. Those in the 
intervention group will be counseled on avoiding LCSB. Participants and their parent will 
also be given a brochure on avoiding LCSBs to take home, which will include a list of 
specific foods and beverages containing LCSBs to avoid during the study. Participants 
in the control group will be counseled by Dr. Meni or a research assistant, and will 
receive identical counseling on healthy eating as those in the intervention group (in 
accordance with standard dietary guidance for T1D management), with the exception of 
information and resources for avoiding LCSB. 
 
In both groups, text messages will be sent to parents 3X/week with reminders that their 
child should avoid LCSBs or continue usual intake, per randomization. Adherence will 
be monitored through collection of spot-urine samples for measurement of sucralose 
and ace-K concentrations (baseline, week 6, week 12), daily text message beverage 
logs completed by the parent, and photo-assisted food records with parent assistance in 
Weeks 0, 6, and 12. During Week 6, participants and their parent will attend a mid-
intervention telemedicine booster visit, during which the PI and/or study RA will 
reinforce the intervention and remind participants to mail back a spot urine sample using 
materials provided by the study team at baseline (instructions enclosed). Participants 
will be reminded of the study instructions, including the importance of inserting the 
DEXCOM G6 sensor (provided by study team) at the beginning of Week 11. Parents will 
receive a phone reminder to insert the sensor at the end of Week 10 and a second call 
early in Week 11 to ensure that the sensor has been placed and will be replaced after 7-
10 days to allow for 14 days of wear time prior to the follow-up visit. Depending on 
randomization assignment, guidance to avoid LCSBs or continue usual diet will be 
reinforced. All participants and their parent will have the opportunity to chat in real-time 
with the study team about questions or concerns.  
 
At the end of Week 12, participants and their parent will return for follow-up in the CRU. 
Participants will have their DEXCOM G6™ sensor removed and CGM data downloaded 
using DEXCOM Clarity™ software. Height and weight will be measured and a urine 
sample and blood draw performed. Those who had a DXA or BodPod at the baseline 
visit (n=30) will undergo a second DXA or BodPod, after which these participants and 
their parent will receive a consultation on the DXA or BodPod results. Those 
randomized to the intervention will be purposefully sampled and asked to complete a 
~20-minute qualitative interview and ~5 minute satisfaction survey, together with their 
parent, about their study experience and the challenges of LCSB restriction. This will 

 
allow us to collect information from individuals with a range of perspectives and varying 
degrees of intervention adherence. Sampling will continue until saturation of ideas is 
reached or until all subjects in the intervention group are invited to be interviewed. Study 
procedures are detailed below. 
 
Table 1. Timing of Study Procedures 
Time-point 
Location Assessments 
Procedures 
Interview 
about 
COVID-19 
impacts on 
T1D 
management 
(separate 
from rest of 
trial) 
Home 
Qualitative interview 
Consent, questionnaire, 
qualitative interview  
Screening 
Visit 
Clinic or 
Home 
Eligibility Determination, 
Enrollment, Questionnaires 
Screener, consent, assent, 
EAT, self-care (SCI), 
COVID-19 questionnaire, 
PROMIS questionnaire 
Week 0 
Home 
Diet assessment, glycemic 
variability 
Food record, CGM, 
beverage log 
Baseline 
Visit 
CRU 
Glycemic control (HbA1c), 
lipids, inflammation, visceral 
adiposity, anthropometrics 
Height/weight, spot urine, 
blood draw, CGM 
download, DXA or BodPod 
(subset) 
Weeks 1-5 
Home 
Adherence 
Food record, beverage log  
Week 6 
Home 
Diet assessment, adherence, 
intervention booster  
Food record, beverage log, 
spot urine 
Week 7-10 
Home 
Adherence 
Beverage log 
Week 11-12 
Home 
Diet assessment, glycemic 
variability, adherence 
Food record, CGM, 
beverage log 
Follow-up 
Visit  
CRU 
Glycemic control (HbA1c), 
lipids, inflammation, visceral 
adiposity, anthropometrics, 
acceptability, feasibility 
Height/weight, spot urine, 
blood draw, SCI, 
satisfaction survey, 
qualitative interview, CGM 
download (for weeks 11 
and 12), DXA or BodPod 
 

 
Laboratory analyses: All blood assays will be run by LabCorps.  Urine analyses will be 
performed by the Clinical Mass Spectrometry Laboratory at the National Institutes of 
Health.  Blood and urine samples will be shipped by certified personnel in the CTSI-CN 
PCI at Children’s National.  
 
Additional blood and urine specimens will be stored in the CTSI-CN PCI at Children’s 
National for up to three years after completion of data collection for future analyses.  All 
samples will be stored deidentified.  Depending on the future analyses performed, 
deidentified samples may be shipped to external commercial or academic laboratories 
in the future.  
 
6.5 
Study Team Training and Intervention Reliability 
All study team members have completed required human subjects training and have 
undergone protocol-specific training with respect to the intervention and all study 
procedures.  
 
SECTION 7 STATISTICAL CONSIDERATIONS AND ANALYSIS 
 
Our primary outcome is the difference in change in glycemic variability in those 
randomized to LCSB restriction compared to controls, calculated as difference in 
average daily TIR in Weeks 11 and 12 compared to Weeks -1 and 0. Because no prior 
study has assessed glycemic variability before and after LCSB restriction, we have 
powered our study using changes before and after LCS consumption. Suez et al., 
reported a 1564 ± 1852 (mg·dL·120 mins) -1 increase in glucose AUC post-LCS versus 
baseline, in 7 volunteers consuming saccharin (equivalent to 4-5 diet sodas per day) for 1 
week. Using a similar effect size, 13 subjects per group will provide 80% power to detect 
differences in glycemic control before and after LCS restriction versus control (G*Power; 
V3). Because 60% (4 of 7) of participants were considered LCS-responders by Suez, 
we will randomize 20 participants to the intervention and control, respectively (n=40). 48 
subjects (24 per group) will account for 20% attrition. However, because prior studies 
conducted by Drs. Streisand and Cogen in this patient population have generated 70-
80% usable CGM data, we will conservatively enroll 60 subjects (n=30 per group). We 
will use 1:1 block randomization stratified by LCSB type (sucralose or aspartame + ace-
K) to lay the groundwork for evaluating potential differences in effects of sucralose 
versus aspartame in future studies.  
 
Univariate analyses will be performed using an intention to treat approach. The 
maximum number of days of glycemic data will be used without imputations for 
missingness. Bivariate associations will be examined using cross tabulations, odds 
ratios, and chi-squared tests; boxplots, mean differences, and ANOVA, and 
correlations, as appropriate. We will identify and validate outliers and non-parametric 
tests will be used in the case of non-normal data. By establishing strengths of crude 
associations and highlighting irregular data, descriptive analyses will be a reference for 
more complex models. Changes in glycemic variability and other metabolic outcomes 
pre/post intervention will be compared between the groups using ANOVA. Hypothesis 

 
testing will be two-sided with a type I error of 0.05. Analyses will be summarized using 
regression estimates, p-values, and 95% CI and performed using SAS 9.4. 
 
Study recruitment, enrollment, and rates of data completion will be used to examine 
feasibility. To assess acceptability, attrition rates will be examined, and qualitative 
interviews will be conducted using 8 open-ended questions to probe for participant 
acceptability, feasibility, and situations where adherence was most challenging. 
Adherence to beverage assignments will be operationalized as any consumption of 
LCSBs in violation of the study protocol. Data collected during qualitative interviews (for 
both interviews at end of full trial and for the separate interview on COVID-19 impacts 
on T1D management) will be transcribed and coded using standard methods and 
analyzed using content analysis. The codebook will include descriptive categories 
based on a priori research questions as well as data-driven categories to identify 
emergent themes. Streisand, and a trained RA will code the first 3 transcripts together 
to develop a preliminary codebook. The RA will independently code the remaining 
transcripts and modify the codebook as themes arise. The team will discuss any 
discrepancies in coding, after which Dr. Streisand will make the final determination. 
 
SECTION 8 DATA QUALITY AND OVERSIGHT 
 
8.1 
Study Team Quality Assurance and Quality Control  
We have developed a quality assurance and data management plan to ensure that 
compliance with our protocol is maintained throughout the study. This will facilitate the 
collection of reliable data, leading to credible research findings with the potential to 
advance the field. The plan outlined below will also ensure that the safety and rights of 
our human subjects are protected.      
Quality control (QC) and quality assurance (QA) will be ongoing throughout the study 
and will primarily by the responsibility of the Principal Investigator Dr. Streisand, who will 
also be responsible for quality management, including oversight of the informed consent 
process. Dr. Streisand will oversee the day-to-day quality control activities (e.g., 
potential errors in data entry).   
 
In addition to the required Human Subjects Training, all study team members will 
receive additional training on all aspects of the protocol. Training will be administered by 
Dr. Streisand. This will include specific instruction on the following components: 
 
1. Study Objectives:  All study team members will be required to read the study 
protocol in its entirely and have a thorough understanding of the rationale and 
significance of the study. All study team members will be required to explain the 
study outcomes of interest and how they are related to the study objectives set 
forth in the protocol.  
2. Inclusion/Exclusion Criteria: All study team members will be asked to make 
eligibility determinations using test screener questionnaires. 
3. Protocol Deviations: All study members will be provided with a detailed SOP for 
detection and reporting of protocol deviations.  
 

 
SECTION 9 ETHICAL CONSIDERATIONS 
 
9.1  
Ethical Standard 
The study team will ensure that this study is conducted in full conformity with the 
Regulations for the Protection of Human Subjects of Research codified in 45 Part 46 of 
the Code of Federal Regulations, Children’s National Policies and Procedures and 
Good Clinical Practices.    
 
9.2 
Institutional Review Board (IRB) 
The protocol, informed consent form(s), recruitment materials, and all participant 
materials will be submitted to the Children’s National IRB for review and approval. 
Approval of both the protocol and the consent form will be obtained before any 
participant is consented. Any change to the protocol, consent, recruitment materials and 
participant information sheets or letters will require IRB approval before implementation 
and use. The IRB will determine whether previously consented participants need to be 
re-consented and whether consent of more than one parent is required for minors.   
The IRB will be notified of study team updates via an amendment. Other study events 
(e.g., protocol deviations, data monitoring reports) will be submitted per the Children’s 
National IRB Reportable Events Module. 
 
9.3 
Maintaining Subject Privacy 
All study procedures will take place in a private room to ensure the participant’s privacy. 
The study participant’s contact information will be securely stored at each study site for 
internal use during the study. At the end of the study, all research records will be stored 
in a secure location for the time period dictated by the sponsor and institutional 
regulations. The research data will not include the participant’s identifying information. 
PHI including name, phone number, and email address will be collected for the clinical 
pilot study; however, all data will be de-identified and PHI will not be disclosed. The 
study data entry and study management systems used by research staff will be secured 
and password protected.  
 
9.4 
Maintaining Study Data Confidentiality 
Participant confidentiality is strictly held in trust by the participating investigators, their 
staff, the sponsor and their agents. This confidentiality is extended to cover information 
relating to participants. Therefore, the study protocol, documentation, data, and all other 
information generated will be held in strict confidence. No information concerning the 
study or the data will be released to any unauthorized third party without prior written 
approval of the sponsor. 
  
The sponsor representatives and regulatory authorities (e.g., IRB, OHRP) may inspect 
all documents and records required to be maintained by the investigator.    The clinical 
study site will permit access to such records. 
 
9.5 
Certificate of Confidentiality 
No Certificate of Confidentiality will be obtained for this study.  
 

 
9.6 
Study Support and Conflicts of Interest 
REDCap® support is provided by The Clinical and Translational Science Institute (CTSI) 
at Children’s National. All key study personnel will follow the Human Research 
Protections Program Investigator, Study Staff, and Family Member Conflicts of Interest 
(COI) Policy. 
 
SECTION 10   DATA QUALITY AND OVERSIGHT 
 
10.1 Data Management Responsibilities 
All data will be entered and managed using RedCap, a password-protected data 
management system.  Data will be entered by trained research assistants and Dr. 
Streisand will check RedCap weekly during periods of active data collection to ensure 
that data entry is correct and up to date.  
 
10.2 Data Capture Methods 
Data collection is the responsibility of the trial staff.  The PI is responsible for ensuring 
the accuracy, completeness, legibility, timeliness and completeness of the data 
reported. Source data include all responses to study questionnaires and dietary recalls.  
 
10.3 Study Record Retention Policy 
Dr. Streisand will keep all study records in a locked cabinet for 5 years after enrollment 
of the last participant.  
 
SECTION 11    ETHICAL CONSIDERATIONS 
 
All study investigators will be co-authors on any publications resulting from this 
research. No subjects will be identified by name in any of the published literature.  All 
study results will be published in aggregate and not attributable to individual participants. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
 
 
SECTION 12    APPENDIX 
 
Eligibility Screener Questionnaire 
 
All answers must be ‘YES’ for study eligibility.  
• Has your child been diagnosed with Type 1 Diabetes (T1D)?  
• Has your child had a diagnosis of T1D for at least one year?  
• Is your child between 5 to 14 years old?  
• Does your child consume at least 12 ounces of a low-calorie sweetened beverage 
on most days (e.g., diet soda, light fruit juice, reduced sugar sports drink, diet iced 
tea?  
• If so, what is the brand of the beverage and does it contain sucralose and/or 
aspartame+ace-K?  
 
• Do you have reliable phone and internet access? 
• Do you and your child both speak English?  
 
• Are you enrolled in the Childhood and Adolescent Diabetes Program at Children’s 
National? 
 
 
All answers must be ‘NO’ for study eligibility. 
• Does your child consume foods with low-calorie sweeteners (e.g., sugar-free ice 
cream, light yogurt, sugar-free oatmeal) more than 3 times per week?  
• Does your child consume condiments with low-calorie sweeteners (e.g., sugar-free 
pancake syrup, sugar-free jam, reduced sugar ketchup) more than 3 times per 
week? 
• Are you currently participating in any other studies?