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Effects of a High Viscosity Dietary Fibre, as Part of a Medically Supervised Weight Management Program

C

Canadian Center for Functional Medicine

Status and phase

Withdrawn
Phase 3

Conditions

Obesity

Treatments

Dietary Supplement: Novel fibre supplement

Study type

Interventional

Funder types

Other
Industry

Identifiers

Details and patient eligibility

About

The aim of this study is to investigate whether the supplementation of a medically supervised weight management program with a novel fibre supplement, improves body weight, body composition, and laboratory measurements in overweight and obese individuals. All subjects will participate in the medical weight management program however the intervention group will have 5 grams of a novel fibre supplemented to each meal while the control group will not.

Sex

All

Ages

20 to 55 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • BMI 27 - 30 Kg/m2 with 1 weight-related comorbidity and/or BMI 30 - 50 Kg/m2
  • Ability to provide written informed consent in accordance with Good Clinical Practice (GCP) and local legislation in English

Exclusion criteria

  • Medications and supplements that affect body weight and appetite
  • Type 2 diabetes on insulin treatment
  • Contraindications to low calorie diet
  • Any allergies to study product ingredients
  • Any other medical, social or geographic condition, which, in the opinion of the investigator would not allow safe completion of the protocol.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

0 participants in 2 patient groups

Novel fibre supplement
Experimental group
Description:
The full dose of the study intervention is 15 grams per day.
Treatment:
Dietary Supplement: Novel fibre supplement
Weight management program
No Intervention group

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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