Effects of NUTRIOSE®FB Dietary Fiber Supplementation on Satiety, Body Fat, and Metabolic Syndrome in Overweight Adult Men

NCT01044680 | Completed Phase 2

• 1 other identifier: 06-10- CN-Roquette-01
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study was to determine the effects of NUTRIOSE® supplementation on body composition, satiety, and determinants of metabolic syndrome in overweight men.

Conditions

Overweight; Metabolic Syndrome X

Keywords

fiber; metabolic syndrome; overweight; satiety

Outcome Measures

Primary Outcomes (1)

• Determinants of metabolic syndrome

  12 weeks

Study Arms (2)

Nutriose

EXPERIMENTAL

17 g NUTRIOSE consumed twice daily for 12 weeks

Dietary Supplement: NUTRIOSE

Placebo

PLACEBO COMPARATOR

17 g maltodextrin consumed twice daily for 12 weeks

Dietary Supplement: Placebo

Interventions

NUTRIOSE DIETARY_SUPPLEMENT

17 grams of NUTRIOSE consumed twice daily for 12 weeks

Nutriose

Placebo DIETARY_SUPPLEMENT

17 g maltodextrin consumed twice daily for 12 weeks

Placebo

Eligibility Criteria

• Age: 20 Years - 35 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• males 20-35 years
• body mass index of 24-28 kg/m2
• current employment and residence at one of three manufacturing plants with a controlled setting and with similar regimented working conditions 7 days a week

You may not qualify if:

• current or recent dietary fiber supplementation
• use of lipid-lowering/hypertension medication
• current insulin injection use
• contraindication to fiber supplements, e.g. Crohn's disease
• allergy to wheat products
• recent or current antibiotic use

Sponsors & Collaborators

• Roquette Freres: lead
• Sprim Advanced Life Sciences: collaborator

Study Sites (1)

Tongji University Medical College

Shanghai, China

Location

Related Publications (4)

• Pasman W, Wils D, Saniez MH, Kardinaal A. Long-term gastrointestinal tolerance of NUTRIOSE FB in healthy men. Eur J Clin Nutr. 2006 Aug;60(8):1024-34. doi: 10.1038/sj.ejcn.1602418. Epub 2006 Feb 15.

  PMID: 16482066 BACKGROUND

• van den Heuvel EG, Wils D, Pasman WJ, Saniez MH, Kardinaal AF. Dietary supplementation of different doses of NUTRIOSE FB, a fermentable dextrin, alters the activity of faecal enzymes in healthy men. Eur J Nutr. 2005 Oct;44(7):445-51. doi: 10.1007/s00394-005-0552-0. Epub 2005 Feb 9.

  PMID: 15696402 BACKGROUND

• van den Heuvel EG, Wils D, Pasman WJ, Bakker M, Saniez MH, Kardinaal AF. Short-term digestive tolerance of different doses of NUTRIOSE FB, a food dextrin, in adult men. Eur J Clin Nutr. 2004 Jul;58(7):1046-55. doi: 10.1038/sj.ejcn.1601930.

  PMID: 15220947 BACKGROUND

• Li S, Guerin-Deremaux L, Pochat M, Wils D, Reifer C, Miller LE. NUTRIOSE dietary fiber supplementation improves insulin resistance and determinants of metabolic syndrome in overweight men: a double-blind, randomized, placebo-controlled study. Appl Physiol Nutr Metab. 2010 Dec;35(6):773-82. doi: 10.1139/H10-074.

  PMID: 21164548 DERIVED

MeSH Terms

Conditions

Overweight; Metabolic Syndrome

Interventions

NUTRIOSE

Condition Hierarchy (Ancestors)

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

Study Officials

• Shuguang Li, MD

  Tongji University Medical College

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 6, 2010
• First Posted: January 8, 2010
• Study Start: October 1, 2006
• Primary Completion: February 1, 2007
• Study Completion: February 1, 2007
• Last Updated: January 8, 2010

Record last verified: 2010-01

Locations

CN (1)