Dietary Intervention for Visceral Adiposity

NCT01350518 | Completed DMC

• 1 other identifier: IRB00013678
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Obesity

Keywords

Intra-Abdominal Fat; Metabolic Syndrome; Hepatic steatosis

Outcome Measures

Primary Outcomes (1)

• Change in abdominal adiposity measured by CT

  Change in area of three abdominal fat depots,namely visceral,subcutaneous and liver fat.

  12 weeks

Secondary Outcomes (1)

• Change in metabolic risk factors

  12 weeks

Study Arms (4)

Study prepared meals and placebo

PLACEBO COMPARATOR

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

Nutritional Counseling with fiber

ACTIVE COMPARATOR

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

Nutrition counseling and placebo

PLACEBO COMPARATOR

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

Study prepared meals and fiber

ACTIVE COMPARATOR

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

Interventions

Benefiber DIETARY_SUPPLEMENT

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.

Nutritional Counseling with fiber; Study prepared meals and fiber

TrueLemon DIETARY_SUPPLEMENT

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.

Nutrition counseling and placebo; Study prepared meals and placebo

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Wake Forest University Clinical Research Unit

Winston-Salem, North Carolina, 27157, United States

Location

Related Publications (3)

• Hairston KG, Scherzinger A, Foy C, Hanley AJ, McCorkle O, Haffner S, Norris JM, Bryer-Ash M, Wagenknecht LE. Five-year change in visceral adipose tissue quantity in a minority cohort: the Insulin Resistance Atherosclerosis Study (IRAS) family study. Diabetes Care. 2009 Aug;32(8):1553-5. doi: 10.2337/dc09-0336. Epub 2009 Jun 1.

  PMID: 19487643 BACKGROUND

• Hairston KG, Bryer-Ash M, Norris JM, Haffner S, Bowden DW, Wagenknecht LE. Sleep duration and five-year abdominal fat accumulation in a minority cohort: the IRAS family study. Sleep. 2010 Mar;33(3):289-95. doi: 10.1093/sleep/33.3.289.

  PMID: 20337186 BACKGROUND

• Liu J, Fox CS, Hickson DA, May WD, Hairston KG, Carr JJ, Taylor HA. Impact of abdominal visceral and subcutaneous adipose tissue on cardiometabolic risk factors: the Jackson Heart Study. J Clin Endocrinol Metab. 2010 Dec;95(12):5419-26. doi: 10.1210/jc.2010-1378. Epub 2010 Sep 15.

  PMID: 20843952 BACKGROUND

MeSH Terms

Conditions

Obesity; Metabolic Syndrome; Fatty Liver

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Liver Diseases; Digestive System Diseases

Study Officials

• Kristen G Hairston, MD MPH

  Wake Forest Unversity Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2011
• First Posted: May 9, 2011
• Study Start: February 1, 2011
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: August 28, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)