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

University of California (UC) Davis

Status: Terminated

Conditions: Healthy

Treatments: Dietary Supplement: Sugar-sweetened beverage

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03611972

1243331

K12HD051958 (U.S. NIH Grant/Contract)

UL1TR001860 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 9 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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9 participants in 1 patient group

Sugar-sweetened beverage (SSB)

Experimental group

Description:

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

Treatment:

Dietary Supplement: Sugar-sweetened beverage