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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03611972
Recruitment Status : Recruiting
First Posted : August 2, 2018
Last Update Posted : November 21, 2019
Sponsor:
Collaborators:
National Institutes of Health (NIH)
Office of Research on Women's Health (ORWH)
National Center for Advancing Translational Science (NCATS)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
University of California, Davis

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.

Condition or disease Intervention/treatment Phase
Healthy Dietary Supplement: Sugar-sweetened beverage Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Dietary intervention
Masking: None (Open Label)
Masking Description: All outcomes measures are analyzed using only the participant's study ID number.
Primary Purpose: Basic Science
Official Title: Effects of Sucrose-sweetened Beverage in African-American and Caucasian Women.
Actual Study Start Date : August 20, 2018
Estimated Primary Completion Date : August 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Sucrose

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.




Primary Outcome Measures :
  1. Triglycerides [ Time Frame: 2 weeks ]
    Fasting and postprandial plasma triglycerides

  2. Total cholesterol [ Time Frame: 2 weeks ]
    Fasting and postprandial plasma cholesterol

  3. Low-density lipoprotein (LDL) [ Time Frame: 2 weeks ]
    Fasting and postprandial plasma low-density lipoprotein (LDL)

  4. Oral glucose tolerance test (OGTT) [ Time Frame: 2 weeks ]
    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.


Secondary Outcome Measures :
  1. Waist circumference [ Time Frame: 2 weeks ]
    Waist circumference



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03611972


Contacts
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Contact: Candice Price, PhD 530-752-5379 caaprice@ucdavis.edu

Locations
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United States, California
University of California, Davis Recruiting
Davis, California, United States, 95616
Contact: Candice Price, PhD    530-752-5379    caaprice@ucdavis.edu   
University of California, Davis CTSC Clinical Research Center Recruiting
Sacramento, California, United States, 95817
Contact: Christopher Kain, RN, MSN, CNL    916-703-5595      
Sponsors and Collaborators
University of California, Davis
National Institutes of Health (NIH)
Office of Research on Women's Health (ORWH)
National Center for Advancing Translational Science (NCATS)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
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Principal Investigator: Candice Price, PhD University of California, Davis
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Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT03611972    
Other Study ID Numbers: 1243331
K12HD051958 ( U.S. NIH Grant/Contract )
UL1TR001860 ( U.S. NIH Grant/Contract )
First Posted: August 2, 2018    Key Record Dates
Last Update Posted: November 21, 2019
Last Verified: November 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No