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| ID | Type | Description | Link |
|---|---|---|---|
| K12HD051958 | U.S. NIH Grant/Contract | View source | |
| UL1TR001860 | U.S. NIH Grant/Contract | View source |
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PI resigned
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| Office of Research on Women's Health (ORWH) | NIH |
| National Center for Advancing Translational Sciences (NCATS) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sugar-sweetened beverage (SSB) | Experimental | SSB provided at 25% of daily energy requirement Frequency: Divided into 3 servings/day Duration: 2 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sugar-sweetened beverage | Dietary Supplement | Sugar-sweetened koolaid-flavored water. |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Waist circumference | Waist circumference | 2 weeks |
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Inclusion Criteria:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Candice Price, PhD | University of California, Davis | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, Davis | Davis | California | 95616 | United States | ||
| University of California, Davis CTSC Clinical Research Center |
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| Label | URL |
|---|---|
| Learn more or sign up for the study here! | View source |
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| ID | Term |
|---|---|
| D000080845 | Sugar-Sweetened Beverages |
| ID | Term |
|---|---|
| D001628 | Beverages |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
| NIH |
Dietary intervention
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All outcomes measures are analyzed using only the participant's study ID number.
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| Sacramento |
| California |
| 95817 |
| United States |