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

Healthy Clinical Trial

— SAAC  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03611972
• Other study ID #: 1243331
• Secondary ID: K12HD051958UL1TR
• Status: Terminated
• Phase: N/A
• Start date: August 20, 2018
• Est. completion date: March 30, 2022

Study information

• Verified date: June 2023
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 9
• Est. completion date: March 30, 2022
• Est. primary completion date: March 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Dietary Supplement:
• Sugar-sweetened beverage
Sugar-sweetened koolaid-flavored water.

Locations

Country	Name	City	State
United States	University of California, Davis	Davis	California
United States	University of California, Davis CTSC Clinical Research Center	Sacramento	California

Sponsors (5)

Lead Sponsor	Collaborator
University of California, Davis	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Center for Advancing Translational Sciences (NCATS), National Institutes of Health (NIH), Office of Research on Women's Health (ORWH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Triglycerides	Fasting and postprandial plasma triglycerides	2 weeks
Primary	Total cholesterol	Fasting and postprandial plasma cholesterol	2 weeks
Primary	Low-density lipoprotein (LDL)	Fasting and postprandial plasma low-density lipoprotein (LDL)	2 weeks
Primary	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	Waist circumference	Waist circumference	2 weeks

External Links

•   Learn more or sign up for the study here!