NCT03611972

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for not_applicable healthy

Timeline
Completed

Started Aug 2018

Longer than P75 for not_applicable healthy

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 27, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 2, 2018

Completed
18 days until next milestone

Study Start

First participant enrolled

August 20, 2018

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2022

Completed
Last Updated

June 15, 2023

Status Verified

June 1, 2023

Enrollment Period

3.6 years

First QC Date

July 27, 2018

Last Update Submit

June 13, 2023

Conditions

Healthy

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (1)

  • Waist circumference

    2 weeks

Study Arms (1)

Sugar-sweetened beverage (SSB)

EXPERIMENTAL

SSB provided at 25% of daily energy requirement Frequency: Divided into 3 servings/day Duration: 2 weeks

Dietary Supplement: Sugar-sweetened beverage

Interventions

Sugar-sweetened beverageDIETARY_SUPPLEMENT

Sugar-sweetened koolaid-flavored water.

Sugar-sweetened beverage (SSB)

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • BMI 25 - 35 kg/m2

You may not qualify if:

  • 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)
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of California, Davis

Davis, California, 95616, United States

Location

University of California, Davis CTSC Clinical Research Center

Sacramento, California, 95817, United States

Location

Related Links

MeSH Terms

Interventions

Sugar-Sweetened Beverages

Intervention Hierarchy (Ancestors)

BeveragesDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Candice Price, PhD

    University of California, Davis

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
All outcomes measures are analyzed using only the participant's study ID number.
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Model Details: Dietary intervention
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 27, 2018

First Posted

August 2, 2018

Study Start

August 20, 2018

Primary Completion

March 30, 2022

Study Completion

March 30, 2022

Last Updated

June 15, 2023

Record last verified: 2023-06

Locations

US(2)