Healthy
Conditions
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.
Interventions
DIETARY_SUPPLEMENTSugar-sweetened beverage
Sugar-sweetened koolaid-flavored water.
Sponsors
National Institutes of Health (NIH)
Office of Research on Women's Health (ORWH)
National Center for Advancing Translational Sciences (NCATS)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
University of California, Davis
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Masking description
All outcomes measures are analyzed using only the participant's study ID number.
Intervention model description
Dietary intervention
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Triglycerides | 2 weeks | Fasting and postprandial plasma triglycerides |
| Total cholesterol | 2 weeks | Fasting and postprandial plasma cholesterol |
| Low-density lipoprotein (LDL) | 2 weeks | Fasting and postprandial plasma low-density lipoprotein (LDL) |
| Oral glucose tolerance test (OGTT) | 2 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Waist circumference | 2 weeks | Waist circumference |
Countries
United States
Outcome results
None listed