The Effects of Sucrose-sweetened Beverage in African-American and Caucasian Women (SAAC) Study

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"In this study, we hope to learn about the metabolism of koolaid beverages that contain added sucrose (table sugar)."
Age: 18-45
Gender:
Female
Healthy Volunteers: Yes
Keywords: sugar, african american women, caucasian women, healthy volunteer, sugar-sweetened beverages
Type: Biological Study
Target:
58 Participants
Investigator:
Description
The main goal of this research study is to learn about the metabolism of koolaid beverages that contain added sucrose (table sugar). We hope that what we learn will help patients in the future. As with all research studies, no one can guarantee that participating in a research study will help you.

We invite you to take part in a research study if you:
- identify as either an African-American or non-hispanic White woman.
- are a woman between the ages of 18-45 years.
- are a nonsmoker who does not have diabetes mellitus or liver, kidney or thyroid disorders.
- do not take hypolipidemic, anti-diabetic, anti-hypertensive or anti-depression medication.
- have a stable body weight during the prior 6 months
This study requires

The study team will make sure you qualify to take part in the study. If you qualify, you may undergo the study-related procedures below.

Dietary protocol: Standardized meals: You will be provided with a standardized diet based on the calories you need for your body weight. You will be asked to consume this the day before and the day of your procedure days.

Study beverages: Study beverages are sucrose (granulated sugar cane)-sweetened koolaid drinks.

Procedure Visits Blood collections: During study days 1 and 15, you have blood drawn after dinner at 4 time points at night (6:00 PM, 7:00PM, 8:00PM, and 9:00 PM). On study days 2 and 16, you will have blood drawn after a 12-hour overnight fast at 6 time points in the morning (8:00 AM, 8:30 AM, 9:00AM, 9:30AM, 10:00AM, 11:00AM).

Oral Glucose Tolerance Test (OGTT): On Study Days 2 and 16, we will perform the OGTT procedure. You will drink 11 ounces of a glucose solution. It will be necessary that you drink all the glucose solution within 5 minutes. Your blood will be sampled at 0 (before the glucose solution) minutes and again 30, 60, 90, 120 and 180 minutes later.

Saliva: On Study Days 1 and 15, in the morning (30 minutes after you awake) and evening (just before you go to bed), we will obtain saliva samples by asking you to drool into a tube.

Breath: On Study Days 1 and 15, we will obtain breath samples by asking you to exhale normally into a collection bag for 1-2 seconds. Your breath samples will be tested for gases and compounds that represent microbial activity in your digestive tract or metabolic processes in body organs.

Urine collection: On Study Days 1, 2, 15 and 16, you will be asked to provide 2 urine samples (one in the morning before fasting blood draw and one at night following dinner). During the outpatient Study Day 8, you will also provide urine samples during the beverage and study meal pick-up visit.

Stool collection: You will be asked to provide a stool sample to test the effects of the sweetened beverages on the types of microorganisms contained in the stools.

Questionnaires: You will be asked to fill out questionnaires about life experiences you may have had that can be challenging, as well as emotional responses and eating behaviors.

Upon completion of the study, you will be asked to complete a brief questionnaire inquiring about your initial interest in our study.

Who can participate

Inclusion criteria:

  • We will study women who self-identify as African-American or non-hispanic White (age 18-45 y; BMI 25-35 kg/m2) with self-reported stable body weight during the prior six months.

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

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

Benefits and risks of participating
BENEFITS:

We cannot promise any benefits to you as a result of taking part in this research study.


RISKS:

The study doctor will discuss the risks associated with taking part in this research study.
Compensation
If you agree to take part in this research study, we will compensate you $305 for your time and effort. If you do not complete the study, you will receive a prorated payment based on the number of study days and procedures completed.
Resources
Schedule
Study duration and period
We expect that you will be in this research study for 17 days.
Recruitment period
From Aug. 20, 2018
Location
UC Davis CTSC Clinical Research Center (CCRC)
2221 Stockton Boulevard
Suite D
Sacramento, CA 95817
Contact
Candice Price, Ph.D.

Have any questions or want to learn more? Leave your contact details below and the research team will reach out to you.


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