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Dietary Intervention for Visceral Adiposity

NCT01350518 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2018-08-28

No results posted yet for this study

Summary

The purpose of this research study is to determine whether increased intake of dietary fiber during a 12-week, low-calorie weight loss intervention affects abdominal fat change and improves cardiovascular risk factors in African-American women more than a standard weight loss intervention.

The investigators are testing two main hypothesis:

Hypothesis 1: Women in the high dietary fiber intervention group will lose significantly more abdominal fat around their organs than women in the standard fiber group.

Hypothesis 2: Women in the high dietary fiber intervention group will have lower blood pressure, fasting glucose, fasting lipids and inflammatory factors at 3-months compared to women in the control group.

Conditions

Interventions

DIETARY_SUPPLEMENT

TrueLemon

Each placebo dietary supplement packet contains 8 grams of Splenda and 3 grams of TRUE® Lemon sweetener. Each packet is designed to be added to 8 oz of fluid. The three packets should be consumed each day in a total of 24 fluid ounces.

DIETARY_SUPPLEMENT

Benefiber

Benefiber® powder will be used as our dietary supplement intervention. Benefiber® powder contains wheat dextrin, a 100% natural fiber. Participants in the intervention arm will receive 3 supplement packets to be consumed per day. Each active dietary supplement packet contains 8 grams of Benefiber® powder and 3 grams of TRUE® lemon flavoring, a 100% natural with no artificial ingredients or sweeteners, preservatives, sodium or gluten.

Sponsors & Collaborators

  • Wake Forest University Health Sciences

    lead OTHER

Principal Investigators

  • Kristen G Hairston, MD MPH · Wake Forest Unversity Health Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-02-28
Primary Completion
2014-03-31
Completion
2014-03-31

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01350518 on ClinicalTrials.gov