Sucrose-sweetened Beverage in African-American and Caucasian Women. (SAAC)

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

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.

Study Overview

• Status: Terminated
• Conditions: Healthy
• Intervention / Treatment: Dietary supplement: Sugar-sweetened beverage

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.

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Candice Price, PhD; Phone Number: 530-752-5379; Email: caaprice@ucdavis.edu

Study Locations

• United States
  • California
    • Davis, California, United States, 95616
      • University of California, Davis
    • Sacramento, California, United States, 95817
      • University of California, Davis CTSC Clinical Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of California, Davis
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); National Institutes of Health (NIH); National Center for Advancing Translational Sciences (NCATS); Office of Research on Women's Health (ORWH)
• Investigators: Principal Investigator: Candice Price, PhD, University of California, Davis

Publications and helpful links

Helpful Links

• Learn more or sign up for the study here!

Study record dates

Study Major Dates

• Study Start (Actual): August 20, 2018
• Primary Completion (Actual): March 30, 2022
• Study Completion (Actual): March 30, 2022

Study Registration Dates

• First Submitted: July 27, 2018
• First Submitted That Met QC Criteria: July 27, 2018
• First Posted (Actual): August 2, 2018

Study Record Updates

• Last Update Posted (Actual): June 15, 2023
• Last Update Submitted That Met QC Criteria: June 13, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 1243331; K12HD051958 (U.S. NIH Grant/Contract); UL1TR001860 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No