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

Primary Purpose

Overweight, Metabolic Syndrome X

Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
NUTRIOSE
Placebo
Sponsored by
Roquette Freres
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Overweight focused on measuring fiber, metabolic syndrome, overweight, satiety

Eligibility Criteria

20 Years - 35 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • Tongji University Medical College

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Nutriose

Placebo

Arm Description

17 g NUTRIOSE consumed twice daily for 12 weeks

17 g maltodextrin consumed twice daily for 12 weeks

Outcomes

Primary Outcome Measures

Determinants of metabolic syndrome

Secondary Outcome Measures

Full Information

First Posted
January 6, 2010
Last Updated
January 7, 2010
Sponsor
Roquette Freres
Collaborators
Sprim Advanced Life Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT01044680
Brief Title
Effects of NUTRIOSE®FB Dietary Fiber Supplementation on Satiety, Body Fat, and Metabolic Syndrome in Overweight Adult Men
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.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2010
Overall Recruitment Status
Completed
Study Start Date
October 2006 (undefined)
Primary Completion Date
February 2007 (Actual)
Study Completion Date
February 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Roquette Freres
Collaborators
Sprim Advanced Life Sciences

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Metabolic Syndrome X
Keywords
fiber, metabolic syndrome, overweight, satiety

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nutriose
Arm Type
Experimental
Arm Description
17 g NUTRIOSE consumed twice daily for 12 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
17 g maltodextrin consumed twice daily for 12 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
NUTRIOSE
Intervention Description
17 grams of NUTRIOSE consumed twice daily for 12 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
17 g maltodextrin consumed twice daily for 12 weeks
Primary Outcome Measure Information:
Title
Determinants of metabolic syndrome
Time Frame
12 weeks

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shuguang Li, MD
Organizational Affiliation
Tongji University Medical College
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tongji University Medical College
City
Shanghai
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
16482066
Citation
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.
Results Reference
background
PubMed Identifier
15696402
Citation
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.
Results Reference
background
PubMed Identifier
15220947
Citation
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.
Results Reference
background
PubMed Identifier
21164548
Citation
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.
Results Reference
derived

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

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