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

This study has been completed.
Sponsor:
Collaborator:
Sprim Advanced Life Sciences
Information provided by:
Roquette Freres
ClinicalTrials.gov Identifier:
NCT01044680
First received: January 6, 2010
Last updated: January 7, 2010
Last verified: January 2010
History of Changes
  Purpose

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.


Condition Intervention Phase
Overweight
Metabolic Syndrome X
 Dietary Supplement: NUTRIOSE
Dietary Supplement: Placebo
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: The Effects of NUTRIOSE®FB Dietary Fiber Supplementation on the Satiety, Body Fat Distribution, and Metabolic Syndrome Biomarkers of Overweight Adult Chinese Men 20-35 Years of Age.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Roquette Freres:

Primary Outcome Measures:
  • Determinants of metabolic syndrome [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 120
Study Start Date: October 2006
Study Completion Date: February 2007
Primary Completion Date: February 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Nutriose
17 g NUTRIOSE consumed twice daily for 12 weeks
 Dietary Supplement: NUTRIOSE
17 grams of NUTRIOSE consumed twice daily for 12 weeks
Placebo Comparator: Placebo
17 g maltodextrin consumed twice daily for 12 weeks
 Dietary Supplement: Placebo
17 g maltodextrin consumed twice daily for 12 weeks

Detailed Description:

Previous trials of fiber supplementation have yielded equivocal results on body composition, satiety, and determinants of metabolic syndrome. This double-blind, randomized, placebo-controlled study was conducted to determine the effects of a proprietary soluble dextrin dietary fiber supplement (NUTRIOSE®) on these parameters in overweight males.

  Eligibility

Ages Eligible for Study:   20 Years to 35 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01044680

Locations
China
Tongji University Medical College
Shanghai, China
Sponsors and Collaborators
Roquette Freres
Sprim Advanced Life Sciences
Investigators
Principal Investigator: Shuguang Li, MD Tongji University Medical College
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Laetitia Guerin-Deremaux, Roquette Freres
ClinicalTrials.gov Identifier: NCT01044680     History of Changes
Other Study ID Numbers: 06-10- CN-Roquette-01
Study First Received: January 6, 2010
Last Updated: January 7, 2010
Health Authority: China: Ethics Committee

Keywords provided by Roquette Freres:
fiber
metabolic syndrome
overweight
satiety

Additional relevant MeSH terms:
Overweight
Metabolic Syndrome X
Body Weight
Signs and Symptoms
 Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on June 18, 2013