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
  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:


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
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, see Learn About Clinical Studies.

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 July 22, 2014