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

R

Roquette

Status and phase

Completed
Phase 3
Phase 2

Conditions

Overweight
Metabolic Syndrome X

Treatments

Dietary Supplement: NUTRIOSE
Dietary Supplement: Placebo

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT01044680
06-10- CN-Roquette-01

Details and patient eligibility

About

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.

Full 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.

Enrollment

120 patients

Sex

Male

Ages

20 to 35 years old

Volunteers

Accepts 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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

120 participants in 2 patient groups, including a placebo group

Nutriose
Experimental group
Description:
17 g NUTRIOSE consumed twice daily for 12 weeks
Treatment:
Dietary Supplement: NUTRIOSE
Placebo
Placebo Comparator group
Description:
17 g maltodextrin consumed twice daily for 12 weeks
Treatment:
Dietary Supplement: Placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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