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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-20

Study Completion Date

2022-03-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

The Metabolic Effects of Consuming Sugar-Sweetened Beverages for Two Weeks

NCT01103921

Metabolic Syndrome Insulin Resistance Dyslipidemia

COMPLETED NA

Short-term Sugary Beverage Consumption on Glucose Control and Cardiovascular Disease Risk Factors

NCT04118257

Metabolic Syndrome

COMPLETED NA

Effects of Sugar Sweetened Beverage on Metabolic Health in Male and Female Adolescents

NCT02058914

Insulin Sensitivity Insulin Tolerance

COMPLETED NA

Online Study of the Effects of Sugary Drink Warning Labels on Consumption

NCT05079477

Food Preferences

COMPLETED NA

Comparison of the Effects of a 12-Week Consumption of Two Carbonated Beverages on Insulin Sensitivity

NCT02031497

Glucose Homeostasis

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Dietary intervention

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

All outcomes measures are analyzed using only the participant's study ID number.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Sugar-sweetened beverage (SSB)

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

Group Type EXPERIMENTAL

Sugar-sweetened beverage

Intervention Type DIETARY_SUPPLEMENT

Sugar-sweetened koolaid-flavored water.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Sugar-sweetened beverage

Sugar-sweetened koolaid-flavored water.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes