Clinical trial NCT06640478: A 12-week Pilot Nutrition Intervention for Children With New Diagnosis of Stage 3 Type 1 Diabetes (T1D)
Official title: NUTRI-Beta Study: A Pilot Clinical Trial for Children With New Diagnosis of Stage 3 Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Type 1 Diabetes
Keywords: T1D
Healthy foods
Children
Youth
Nutrition Counseling
Diabetes mellitus type 1
Nutrition
Honeymoon phase
partial remission of diabetes
new diagnosis of type 1 diabetes
healthy eating
Nutrition Intervention
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
First posted: 2024-10-15
Enrollment: 20
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this research study is to investigate the effects of a combination of weekly distribution of healthy foods and intensive nutrition counseling as complementary therapies to the standard insulin therapy in children with new diagnosis of stage 3 type 1 diabetes (T1D). Feasibility, acceptability, and fidelity of this intervention will be measured. We will also explore the likelihood of prolonging the honeymoon phase of T1D in the intervention study group. Comparisons will be made between this combined nutrition intervention and free healthy foods vs. current standard nutrition counseling. Both study groups will receive standard of care treatment for T1D (insulin therapy).

The results of this study could inform future research that will ultimately lead to design of a larger clinical trial testing implementation of novel medical nutrition therapies for children newly diagnosed with stage 3 of T1D, and may lead to prolongation of the honeymoon phase. The overall goal is to promote the beta cell function survival and to reduce the progression to stage 4 of T1D.

Condition or Disease:

* Type 1 Diabetes Mellitus
* New Diagnosis of Stage 3 Type 1 Diabetes ≤ 60days

Intervention/Treatment:

- Weekly Free Healthy Foods + Intensive Nutrition Counseling for 12 weeks

Detailed description: The proposed study is a 12-week pilot, single-blinded, randomized, controlled clinical trial in prepubertal children (6-17 years old) newly diagnosed with stage 3 of type 1 diabetes (T1D) within 60 days. The total duration of the study is 24 weeks, but the nutrition intervention is only delivered during 12 weeks with a 24-week follow up visit. We expect to enroll a total of 12-20 children (6-12 per study group).

We will be investigating the potential role of a frequent personalized nutrition counseling intervention (7 sessions in a hybrid model) in addition to weekly distribution of selected healthy foods. We expect the diet quality of the youth receiving the intervention (you) will improve during and after the study intervention.

There will be two study groups: intervention and control group.

The intervention group will receive a food bag containing specific healthy foods with high anti-inflammatory properties weekly for 12 weeks, in addition to seven nutrition counseling sessions. The provided foods are a combination of 6 types of foods including: a) seasonal fruits (containing high amounts of vitamin C and vitamin E), b) legumes, c) nuts, d) yogurt, e) vegetables and f) seafood. The portions of each food group component of the "healthy foods bag" will follow the current USDA dietary guidelines according to the age of the study participant. \[1\] By contrast, the control group will receive weekly grocery store gift cards of similar monetary value of the "healthy food bag" in addition to seven nutrition counseling sessions based on the standard MyHealthy plate model.

In regards to the nutrition counseling sessions, this counseling will be provided as a hybrid model with a combination of 4 in-person nutrition counseling sessions and 3 virtual dietary counseling sessions provided by a registered dietitian. In summary:

1. Intervention group will receive NUTRI-Beta foods basket + nutrition counseling (NUTRI-Beta dietary counseling) + standard insulin treatment (either insulin injections or insulin pump per patient preference)+ standard of care insulin therapy and use of a 24-hour continuous glucose monitor, and
2. Control group will receive the standard nutrition counseling per the American Dietary Association (ADA) Guidelines \[2\] + weekly grocery store gift cards + standard of care insulin therapy and use of a 24-hour continuous glucose monitor.

The NUTRI-Beta clinical trial study visits will include a total of 10 visits during the 24 weeks of the study: Screening visit (V0), baseline visit (enrolment visit= V1), nutrition counseling visit 2 (week 2 post enrollment), nutrition counseling visit 3 (V3-virtual, week 3), nutrition counseling visit 4 (V4-in person, week 4), nutrition counseling visit 5 (V5-virtual, week 6), nutrition counseling visit 6 (V6-in person, week 8), nutrition counseling visit 7 (V7-virtual, week 10), visit 8 ( 12 weeks after enrollment- end of nutrition intervention), and visit 9 (24 weeks after enrollment).

We expect that this nutrition intervention (NUTRI-Beta) will be acceptable to children with new diagnosis of clinical diabetes (stage 3 of T1D) and will improve their diet intake and quality, their nutrition status and may increase their likelihood of residual beta-cell function in the treatment group. Evaluation of the partial remission of T1D will be completed through the determination of the insulin dose-adjusted A1C (IDAA1C) and residual beta cell function through the measurement of peak C-peptide levels during a 2-hour mixed-meal tolerance test (MMTT) after 12 and 24 weeks of the nutrition intervention.

The treatment group is expected to have higher rates of partial remission of T1D measured by the IDAA1C, better diet quality, better glycemic metrics and reduced needs of total daily dose of insulin (TDD) (unit/kg/day).

Eligibility criteria: Inclusion Criteria:

1. Willing and able to give assent and to have a parent or legal guardian to provide informed consent
2. Less or equal than 60 days from T1D diagnosis based on American Diabetes Association criteria, and metabolically stable per study physician assessment
3. Boys and girls (Any Tanner stage), 6-17 years of age, at time of enrollment visit
4. Evidence of at least one positive T1D autoantibody (excluding insulin antibodies in those who have received ≥ 2 weeks of exogenous insulin therapy) either through clinically obtained labs at time of diagnosis or as obtained at the screening visit
5. Children with new diagnosis of T1D need to be established patients from Penn State Health- Pediatric diabetes clinic at the time of the enrollment visit
6. Capability to eat different types of food by mouth
7. Daily use of a 24-hour continuous glucose monitor by the time of the enrollment visit
8. Willing and being able to give assent and have a parent or legal guardian provide informed consent

Exclusion Criteria:

1. Children with new diagnosis of T1D who are not metabolically stable (E.g. acute dehydration, severe hyperglycemia with moderate/large ketones at the time of the enrollment visit)
2. Concurrent or recent (within the past 30 days of screening) use of non-insulin therapies to control hyperglycemia including immunosuppressive therapies
3. Chronic inflammatory or autoimmune diseases with exception of stable autoimmune thyroid disease
4. Children requiring enteral feeds or parenteral nutrition support
5. Diagnosis of celiac disease or being actively evaluated for possible celiac disease, inflammatory bowel disease or any underlying illness cause acute or chronic intestinal malabsorption.
6. Use of glucocorticoids or other immunosuppressive agents within 30 days of T1D diagnosis
7. Use of medications known to influence glucose intolerance within 30 days of T1D diagnosis
8. Food allergies (nuts, soy, seafood, milk-protein, or as deemed by the principal investigator) that are a barrier for consumption of a balanced diet that meets nutrient requirements
9. Prior diagnosis or positive screening of food sensory disorders
10. Any condition that, in the investigator's opinion, may compromise study participation or may confound the interpretation to the study results

Primary outcomes:
measure: Recruitment rates
timeFrame: 6 months
measure: Enrollment rates
timeFrame: 6 months
measure: Amount of time required to recruit the target sample (approx. 12- 20 people)
timeFrame: 6 months
measure: Number of subjects required to be screened to meet required sample size (approx. 12- 20 people)
timeFrame: 6 months
measure: Number of participants who completed the 12-week intervention
timeFrame: 12 weeks
measure: Average number of provided foods consumed during the day over the course of the intervention
timeFrame: 12 weeks
measure: Number of participants who completed the Mixed-meal tolerance test at the enrollment visit
timeFrame: Baseline
measure: Number of participants who completed the Mixed-meal tolerance test at the 12-week visit
timeFrame: 12 weeks
measure: Number of participants who completed the Mixed-meal tolerance test at the 24-week visit
timeFrame: 24 weeks
Secondary outcomes:
measure: Healthy Eating Index (HEI) change from baseline to the 12-week visit
timeFrame: 12 weeks
measure: Healthy Eating Index (HEI) change from baseline to the 24-week visit.
timeFrame: 24 weeks
measure: Weight changes from baseline visit to the 12-week visit
timeFrame: 12weeks
measure: Weight changes from baseline visit to the 24-week visit
timeFrame: 24 weeks
measure: Weight Z-score changes from baseline visit to the 12 week visit
timeFrame: 12 weeks
measure: Weight Z-score changes from baseline visit to the 24 week visit
timeFrame: 24 weeks
measure: Height changes from baseline to the 12 week visit
timeFrame: 12 weeks
measure: Height changes from baseline to the 24 week visit
timeFrame: 24 weeks
measure: Height Z-score changes from baseline to the 12 week visit
timeFrame: 12 weeks
measure: Height Z-score changes from baseline to the 24 week visit
timeFrame: 24 weeks
measure: Body Mass Index (BMI) changes from baseline to the 12 week visit
timeFrame: 12 weeks
measure: Body Mass Index (BMI) changes from baseline to the 24 week visit
timeFrame: 24 weeks
measure: BMI Z-score changes from baseline to 12 weeks
timeFrame: 12 weeks
measure: BMI Z-score changes from baseline to 24 weeks
timeFrame: 24 weeks
measure: Height velocity changes from baseline visit to the 12-week visit
timeFrame: 12 weeks
measure: Height velocity changes from baseline visit to the 24-week visit
timeFrame: 24 weeks
measure: Percentage of time in range (TIR) glucose levels from baseline to 3 month intervention visit
timeFrame: 3 months
measure: Percentage of time in range (TIR) glucose levels from baseline to 6-month post intervention visit
timeFrame: 24 weeks
measure: Percentage of time above range (TAR) glucose levels from baselines to 3 month intervention visit
timeFrame: 3 months
measure: Percentage of time above range (TAR) glucose levels from baseline to the 6 -month post intervention visit
timeFrame: 6 months
measure: Percentage of time below range (TBR) glucose levels from baselines to 3 month intervention visit
timeFrame: 3 months
measure: Percentage of time below range (TBR) glucose levels from baselines to 6 month post intervention visit
timeFrame: 6 months
measure: Percentage of mean glucose level from baseline to 12-week visit
timeFrame: 12 weeks
measure: Percentage of average glucose levels from baseline to 6 month post intervention visit
timeFrame: 6 months
measure: Percentage of standard deviation of glucose levels from baseline to 3 month intervention visit
timeFrame: 3 months
measure: Percentage of standard deviation of glucose levels from baseline to 6 month post intervention visit
timeFrame: 6 months
measure: Percentage of coefficient of variation (CV) of glucose levels from baseline to 3 month intervention visit
timeFrame: 3 months
measure: Percentage of coefficient of variation (CV) of glucose levels from baseline to 6 month post intervention visit
timeFrame: 6 months
measure: Percentage of glucose management index (GMI) of glucose levels from baseline to 3 month intervention visit
timeFrame: 3 months
measure: Percentage of glucose management index (GMI) of glucose levels from baseline to 6 month post intervention visit
timeFrame: 6 months
measure: Percentage of hemoglobin A1C (HbA1C) of glucose levels from baseline to 3-month intervention visit
timeFrame: 3 months
measure: Percentage of hemoglobin A1C (HbA1C) of glucose levels from baseline to 6 month post intervention visit
timeFrame: 6 months
measure: Dietary intake changes on daily total K- calories from baseline visit to 12 week visit
timeFrame: 12 weeks
measure: Dietary intake changes on daily total K- calories from baseline visit to 24 week visit
timeFrame: 24 weeks
measure: Macronutrient intake composition from baseline to 12 week visit
timeFrame: 12 weeks
measure: Macronutrient intake composition from baseline to 24 week visit
timeFrame: 24 weeks
measure: Micronutrient intake composition from baseline to 12 week visit
timeFrame: 12 weeks
measure: Micronutrient intake composition from baseline to 24 week visit
timeFrame: 24 weeks
measure: Changes in the baseline levels of carotenoids, vitamin C and vitamin E
timeFrame: 12 weeks
measure: Changes in the baseline levels of carotenoids, vitamin C and vitamin E
timeFrame: 24 weeks
measure: Changes on the levels of 25-hydroxy vitamin D
timeFrame: 12 weeks
measure: Changes on the levels of 25-hydroxy vitamin D
timeFrame: 24 weeks
measure: Omega 3 index (O3i) levels changes during the clinical trial
timeFrame: 12 weeks
measure: Omega 3 index levels during clinical trial
timeFrame: 24 weeks
measure: Middle Upper Arm Circumference (MUAC) changes
timeFrame: 12 weeks
measure: Middle Upper Arm Circumference (MUAC)
timeFrame: 24 weeks
Other outcomes:
measure: Area under the curve and peak C-peptide level determined by MMTT (Mixed Meal Tolerance Test)
timeFrame: 2 hours
measure: Change in the total daily dose of exogenous insulin (TDD) as units/kg/day from baseline to the 12-week visit
timeFrame: 12 weeks
measure: Change in the total daily dose of exogenous insulin (TDD) as units/kg/day from baseline to the 24-week visit.
timeFrame: 24 weeks
measure: Change in the IDAA1C from enrollment (baseline) visit to the 12-week study visit
timeFrame: 12 weeks
measure: Change on the IDAA1C from enrollment (baseline) visit to the 24-week study visit
timeFrame: 24 weeks
Locations:
city: Hershey
country: United States
facility: Penn State Health Children's
state: Pennsylvania
city: Hershey
country: United States
facility: Penn State Milton S. Hershey Medical Center
state: Pennsylvania
Study officials:
affiliation: Pediatric Endocrinologist, Assistant Professor of Pediatrics, Penn State Health Milton Hershey Medical Center, Penn State College of Medicine
name: Lina Huerta Saenz, MD, FAAP
role: PRINCIPAL_INVESTIGATOR
References: