Clinical trial NCT03611972: Sucrose-sweetened Beverage in African-American and Caucasian Women.
Official title: Effects of Sucrose-sweetened Beverage in African-American and Caucasian Women.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Healthy
Lead sponsor: University of California, Davis
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: Office of Research on Women's Health (ORWH)
name: National Center for Advancing Translational Sciences (NCATS)
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2018-08-02
Enrollment: 9
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Dietary intervention
Primary purpose: BASIC_SCIENCE

Brief summary: The main objective of this pilot study is to measure changes in metabolic risk factors of cardiovascular disease and type 2 diabetes in response to sugar-sweetened beverages in African-American and non-Hispanic white women.

Detailed description: This is a dietary intervention during which participants will consume a SSB daily, with each meal for two weeks. At the beginning and end of the two-week intervention, participants will have blood drawn under fasting and postprandial (after a meal) conditions for the measurement of lipid risk factors associated with cardiovascular disease. Participants will also undergo an oral glucose tolerance test (OGTT) to assess insulin sensitivity. All sugar-sweetened beverages will be provided.

Eligibility criteria: Inclusion Criteria:

* BMI 25 - 35 kg/m2

Exclusion Criteria:

* Does not identify as African-American or non-hispanic White
* Glucose intolerance (fasting glucose \>100 mg/dl)
* Evidence of liver disorder (AST or ALT \>200% upper limit of normal range)
* Evidence of kidney disorder (\>2.0mg/dl creatinine)
* Evidence of thyroid disorder (out of normal range)
* Systolic blood pressure consistently over 140mmHg or diastolic blood pressure over 90mmHg
* Triglycerides \> 150mg/dl
* LDL-C \> 130mg/dl
* Hemoglobin \< 8.5 g/dL
* Pregnant or lactating women
* Current, prior (within 12 months), or anticipated use of any hypolipidemic or anti-diabetic agents PROTOCOL TITLE: The Effects of Sucrose Beverage on African-American and Caucasian Women (SAAC) Study Page 4 of 18 Revised: November 27, 2013
* Use of thyroid, anti-hypertensive, anti-depressant, weight loss medications or any other medication which, in the opinion of the investigator, may confound study results
* Use of chronic corticosteroids (everyday use for a month or longer)
* Use of tobacco
* Strenuous exerciser (\>3.5 hours/week at a level more vigorous than walking)
* Surgery for weight loss
* Diet exclusions: Food allergies, special dietary restrictions, food allergies, routine consumption of less than 3 meals/day, routine ingestion of more than 2 sugar-sweetened beverages or 1 alcoholic beverage/day, unwillingness to consume any food on study menu
* Veins that are assessed by the CCRC R.N.s as being unsuitable for long-term infusions and multiple blood draws from a catheter
* Any other condition that, in the opinion of the investigators, would put the subject at risk
* We will exclude individuals from each of the following special populations:

  * Adults unable to consent
  * Individuals who are not yet adults (infants, children, teenagers \< 18 years)
  * Pregnant women
  * Prisoners

Primary outcomes:
measure: Triglycerides
timeFrame: 2 weeks
measure: Total cholesterol
timeFrame: 2 weeks
measure: Low-density lipoprotein (LDL)
timeFrame: 2 weeks
measure: Oral glucose tolerance test (OGTT)
timeFrame: 2 weeks
Secondary outcomes:
measure: Waist circumference
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Davis
country: United States
facility: University of California, Davis
state: California
city: Sacramento
country: United States
facility: University of California, Davis CTSC Clinical Research Center
state: California
Study officials:
affiliation: University of California, Davis
name: Candice Price, PhD
role: PRINCIPAL_INVESTIGATOR
References: