NCT03257449

Brief Summary

Abstract: Background: Obesity is a global pandemic affects all age groups and is independent risk factors for most chronic diseases. Dietary intervention is an essential component of obesity management. Dietary fibre supplements have the potential to facilitate weight reduction based on their viscosity. Up to date, the evidence of effects of some fibres on weight is inadequate, and literature provides insufficient information about the effects of the fibre viscosity in weight management. Objective: Two systematic reviews and meta-analyses of RCTs will be conducted to evaluate the effectiveness of viscous fibres, (agar, alginate, b-glucan from oat and barley, guar gum, glucomannan, pectin, PGX, psyllium), on body weight reduction. Methods: Only randomised controlled trials are accepted. The trails must have one of the selected fibres as a supplement, and the outcomes must have body weight, BMI, waist circumference, or body fat percentage. Studies shorter than 4 weeks are excluded. Three databases, (Medline, EMBASE, and Cochrane library), were searched through 04/03/2016. Results: After removing duplicates, 82 studies will be reviewed in full. Significance: This meta-analysis is the first meta-analysis that is based on fibre viscosity, and it will quantify the effect of each fibre in improving weight loss. It will also direct future research in the best direction to further explore this area.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,268

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2016

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2016

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

August 17, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 22, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2017

Completed
Last Updated

August 22, 2017

Status Verified

August 1, 2017

Enrollment Period

1.7 years

First QC Date

August 17, 2017

Last Update Submit

August 17, 2017

Conditions

Overweight and ObesityT2DM (Type 2 Diabetes Mellitus)General Population

Keywords

Body WeightWeight lossBMIWaist CircumferenceBody Fat PercentageViscofiberViscous Fibressupplement

Outcome Measures

Primary Outcomes (4)

  • Body weight chang

    unit of measure: Kg

    in 4 weeks or more

  • BMI change

    unit of measure: Kg/m2

    in 4 weeks or more

  • Waist circumference change

    unit of measure: Cm

    in 4 weeks or more

  • Body fat percentage change

    unit of measure: %

    in 4 weeks or more

Interventions

Viscous FibreDIETARY_SUPPLEMENT

Meta-analysis of Randomized Controlled Trials

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

This study includes all population types.

You may qualify if:

  • Must be a randomized controlled clinical trial with either a parallel or cross-over design
  • Must have a treatment period of at least 4 week.
  • Healthy children and adults, overweight and obese individuals or individuals with diabetes were all acceptable
  • Must have one of the selected viscous fibres, (agar, alginate, β-glucan, guar gum, pectin, polyglycoplex(PGX), Psyllium, Xanthan), as a supplemented treatment.
  • Only β-glucan sources from barley or oat were accepted The amount of barley product or barley β-glucan must be reported or measured, or must be computable. β-glucan was considered to be 4.75% in barley, and 3-5% in oat.
  • Must be appropriately controlled.
  • Must measure one of outcomes: body weight, BMI, waist circumference, or Body fat percentage.
  • These Anthropometry measures can be either primary or secondary outcomes.
  • Enough information must be provided to calculate the magnitude of effect, i.e. end of treatment measures and/or change from baseline measures
  • Ad lipitum diet only.

You may not qualify if:

  • If the soluble fibre was not one of the selected viscous fibre or a combination.
  • supplement where these fibers could not be isolated each one alone.
  • If the study was insufficiently controlled, i.e. the control was another soluble fibre.
  • If the outcome measures did not include body weight, BMI, waist circumference, or Body fat percentage.
  • If the intervention was a diet with no supplemented fibre.
  • If the study provided insufficient information to calculate a magnitude of effect
  • If the study protocol maintains baseline weight.
  • Secondary information such as reviews, editorials, commentaries, were excluded
  • If the diet is hypo-caloric, energy restricted diet, or metabolically controlled diet.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Toronto 3D Knowledge Synthesis and Clinical Trials Unit, Clinical Nutrition and Risk Factor Modification Centre

Toronto, Ontario, M5C 2T2, Canada

Location

Related Publications (2)

  • Jovanovski E, Mazhar N, Komishon A, Khayyat R, Li D, Blanco Mejia S, Khan T, Jenkins AL, Smircic-Duvnjak L, Sievenpiper JL, Vuksan V. Effect of viscous fiber supplementation on obesity indicators in individuals consuming calorie-restricted diets: a systematic review and meta-analysis of randomized controlled trials. Eur J Nutr. 2021 Feb;60(1):101-112. doi: 10.1007/s00394-020-02224-1. Epub 2020 Mar 20.

    PMID: 32198674DERIVED

  • Jovanovski E, Mazhar N, Komishon A, Khayyat R, Li D, Blanco Mejia S, Khan T, L Jenkins A, Smircic-Duvnjak L, L Sievenpiper J, Vuksan V. Can dietary viscous fiber affect body weight independently of an energy-restrictive diet? A systematic review and meta-analysis of randomized controlled trials. Am J Clin Nutr. 2020 Feb 1;111(2):471-485. doi: 10.1093/ajcn/nqz292.

    PMID: 31897475DERIVED

MeSH Terms

Conditions

OverweightObesityDiabetes Mellitus, Type 2Body WeightWeight Loss

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesEndocrine System DiseasesBody Weight Changes

Study Officials

  • Nourah Mazhar, MSc (C)

    St.Michael Hospital

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 17, 2017

First Posted

August 22, 2017

Study Start

March 1, 2016

Primary Completion

November 1, 2017

Study Completion

November 1, 2017

Last Updated

August 22, 2017

Record last verified: 2017-08

Locations

CA(1)