Sucrose-sweetened Beverage in African-American and Caucasian Women.

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effects of Sucrose-sweetened Beverage in African-American and Caucasian Women.

Conditions
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Healthy

Intervention / Treatment
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* Dietary Supplement: Sugar-sweetened beverage


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Interventional Model Description: Dietary intervention
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sugar-sweetened beverage (SSB)<br>SSB provided at 25% of daily energy requirement Frequency: Divided into 3 servings/day Duration: 2 weeks | Dietary Supplement: Sugar-sweetened beverage<br>* Sugar-sweetened koolaid-flavored water.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Triglycerides | Fasting and postprandial plasma triglycerides | 2 weeks | 
| Total cholesterol | Fasting and postprandial plasma cholesterol | 2 weeks | 
| Low-density lipoprotein (LDL) | Fasting and postprandial plasma low-density lipoprotein (LDL) | 2 weeks | 
| Oral glucose tolerance test (OGTT) | Participants will drink a beverage containing 75g of glucose and blood will be drawn before the drink and at 30 minutes, 60 minutes, 90 minutes, 120 minutes and 180 minutes after the drink. Plasma glucose and insulin will be measured at each time point. | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Waist circumference | Waist circumference | 2 weeks |