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TerminatedNCT03611972SAACUpdated Jun 15, 2023

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

An interventional study of Sugar-sweetened beverage in Healthy, sponsored by University of California, Davis. Terminated at 2 sites in United States. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-06-15.

Sponsored by University of California, Davis · Not applicable, Interventional, and Basic science

Why this study was terminated
PI resigned
Phase
Not applicable
Study type
Interventional
Enrollment
9
Allocation
Not applicable
Ages
18 Years to 45 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Healthy
03

In context

Lead sponsor

University of California, Davis is the lead sponsor of 798 studies on the registry; 146 are open to participants now.

Of its 65 completed or terminated interventional studies of FDA-regulated products, 43 (66%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • BMI 25 - 35 kg/m2

Exclusion 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:

    • Adults unable to consent
    • Individuals who are not yet adults (infants, children, teenagers \< 18 years)
    • Pregnant women
    • Prisoners
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
9 participants (actual)

Study arms

  • 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

Interventions

  • Dietary supplementSugar-sweetened beverage

    Sugar-sweetened koolaid-flavored water.

06

What researchers measure

Primary outcomes

  1. Triglycerides

    Fasting and postprandial plasma triglycerides

    Time frame: 2 weeks

  2. Total cholesterol

    Fasting and postprandial plasma cholesterol

    Time frame: 2 weeks

  3. Low-density lipoprotein (LDL)

    Fasting and postprandial plasma low-density lipoprotein (LDL)

    Time frame: 2 weeks

  4. 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.

    Time frame: 2 weeks

Secondary outcomes

  1. Waist circumference

    Waist circumference

    Time frame: 2 weeks

07

Study locations

2 sites
  • University of California, Davis
    Davis, California 95616, United States
  • University of California, Davis CTSC Clinical Research Center
    Sacramento, California 95817, United States
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 15, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03611972
Lead sponsor
University of California, Davis
Collaborators
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)
Responsible party
Sponsor
First posted
Aug 2, 2018
Start date
Aug 20, 2018
Primary completion
Mar 30, 2022
Completion
Mar 30, 2022
Last update
Jun 15, 2023

Study contacts

Candice Price, PhD
principal investigator · University of California, Davis

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.

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