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

  • STATUS
    Recruiting
  • days left to enroll
    35
  • participants needed
    20
  • sponsor
    University of California, Davis
Updated on 22 March 2022
Accepts healthy volunteers

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.

Details
Condition Healthy
Treatment Sugar-sweetened beverage
Clinical Study IdentifierNCT03611972
SponsorUniversity of California, Davis
Last Modified on22 March 2022

Eligibility

Yes No Not Sure

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
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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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