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Dietary Intervention for Visceral Adiposity (DIVA-Pilot)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by Wake Forest University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Wake Forest University
ClinicalTrials.gov Identifier:
NCT01350518
First received: May 6, 2011
Last updated: August 15, 2011
Last verified: March 2011
History of Changes
  Purpose

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.


Condition Intervention
Obesity
 Dietary Supplement: Benefiber
Dietary Supplement: TrueLemon

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Dietary Intervention for Visceral Adiposity-Pilot

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Wake Forest University:

Primary Outcome Measures:
  • Change in abdominal adiposity measured by CT [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    Change in area of three abdominal fat depots,namely visceral,subcutaneous and liver fat.


Secondary Outcome Measures:
  • Change in metabolic risk factors [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    glucose, insulin, lipids, inflammatory markers, adipokines, blood pressure, BMI, 25-OH vitamin D


Estimated Enrollment: 30
Study Start Date: February 2011
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Study prepared meals and placebo
Participants will have meals designed specifically for them based on their caloric needs. Participants will choose a weeks worth of meals (from a menu) and pick them up from the Clinical Research Unit twice a week. Participants will not receive any fiber supplementation.
 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.
Active Comparator: Nutritional Counseling with fiber
Participants receiving nutritional education will have two individual sessions (spaced approx. 2 weeks apart). The nutritional sessions will focus on knowledge, self-regulation, motivation, experience and environment. Participants will receive fiber supplementation.
 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.
Placebo Comparator: Nutrition counseling and placebo
Participants receiving nutritional education will have two individual sessions (spaced approx. 2 weeks apart). The nutritional sessions will focus on knowledge, self-regulation, motivation, experience and environment.Participants will receive no fiber supplementation.
 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.
Active Comparator: Study prepared meals and fiber
Participants will have meals designed specifically for them based on their caloric needs. Participants will choose a weeks worth of meals (from a menu) and pick them up from the Clinical Research Unit twice a week. Participants will receive fiber supplementation.
 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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   20 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Pre-menopausal
  • Self-identified as an African-American woman
  • Aged 20-50 years
  • Willing and able to provide informed consent
  • No contraindication to weight loss

Exclusion Criteria:

  • Diabetes or currently taking medication to lower blood sugar
  • Currently on lipid lowering medications
  • Currently taking chronic steroids
  • Current diagnosis of kidney or heart failure
  • Untreated hypothyroidism or hyperthyroidism
  • BMI < 30 kg/m2 or waist circumference < 88 cm
  • Current fiber supplementation
  • Current pregnancy
  • Body mass > 140 kg (CT limit)
  • Inability to speak or read English
  • Gastrointestinal disorders that prohibit the increased consumption of fiber
  • Current participation in a structured weight loss/diet intervention program
  • Inability to consume artificial sweeteners
  • Inability or unwillingness to travel to the CRU during operating hours at the required frequency.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01350518

Contacts
Contact: Kristen G Hairston, MD, MPH 3367137616 kghairst@wfubmc.edu
Contact: Nancy Lawlor, RN

Locations
United States, North Carolina
Wake Forest University Clinical Research Unit Recruiting
Winston Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Wake Forest University
Investigators
Principal Investigator: Kristen G Hairston, MD MPH Wake Forest Unversity Health Sciences
  More Information

Publications:

Responsible Party: Kristen Gill Hairston, MD, MPH, Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT01350518     History of Changes
Other Study ID Numbers: 00579
Study First Received: May 6, 2011
Last Updated: August 15, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Wake Forest University:
Intra-Abdominal Fat
Metabolic Syndrome
Hepatic steatosis

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
 Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on May 23, 2013