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Dietary Intervention for Visceral Adiposity (DIVA-Pilot)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01350518
First Posted: May 9, 2011
Last Update Posted: November 7, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Wake Forest University Health Sciences
  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 (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Dietary Intervention for Visceral Adiposity-Pilot

Resource links provided by NLM:


Further study details as provided by Wake Forest University Health Sciences:

Primary Outcome Measures:
  • Change in abdominal adiposity measured by CT [ Time Frame: 12 weeks ]
    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 ]
    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 2018
Primary Completion Date: March 2013 (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 (Benefiber) supplementation in their TrueLemon mixture.
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 (Benefiber) supplementation as the fiber intervention in their TrueLemon mixture .
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 (interventions) will focus on knowledge, self-regulation, motivation, experience and environment.Participants will receive no fiber supplementation in their TrueLemon mixture .
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 (Benefiber) supplementation as the fiber intervention in their TrueLemon mixture.
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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01350518


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