Viewing Study NCT03257449



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Last Modification Date: 2024-10-26 @ 12:30 PM
Study NCT ID: NCT03257449
Status: UNKNOWN
Last Update Posted: 2017-08-22
First Post: 2017-08-17

Brief Title: Effect of Viscous Soluble Fibres on Body Weight
Sponsor: Unity Health Toronto
Organization: Unity Health Toronto

Study Overview

Official Title: Effect of Viscous Soluble Fibres on Body Weight Parameters Review and Meta-analyses
Status: UNKNOWN
Status Verified Date: 2017-08
Last Known Status: ACTIVE_NOT_RECRUITING
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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 04032016

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
Detailed Description: Background Obesity is a global pandemic and is an independent risk factor for chronic disease Dietary intervention is an essential component of obesity management Observational studies show an inverse relationship between dietary fibres and body weight Therefore supplements of dietary fibres have the potential to facilitate weight reduction possibly on the basis of the viscous properties of the fibre Viscosity is the ability of gel forming that holds water and increase satiety and decreases the amount of intake food This ability makes dietary fibre supplements considered as appetite suppressants To date the evidence of the effect of dietary fibre on weight is inconsistent and controversial and may be dependent on the ability of fibre to induce viscosity Three previous meta-analyses on Konjac show inconsistency on the effect and its significance In addition other meta-analyses on individual viscous fibres show that some viscous fibre does not has an effect on body weight This is the first meta-analysis that studies the effect of all these fibres together based on their viscosity

Objective Two systematic reviews and meta-analyses of RCTs will be conducted to evaluate the effect of viscous and non-viscous fibres on body weight BMI waist circumference and body fat percentage

Methods To meet eligibility criteria the study should be randomized controlled include one of the selected fibres agar alginate b-glucan from oat and barley guar gum konjac pectin PGX Psyllium and xanthan as a supplement and one of the required outcomes body weight BMI waist circumference or body fat percentage Studies shorter than 4 weeks in duration will be excluded Three databases Medline EMBASE and Cochrane Library were searched After the search a titleabstract screening was done to exclude the ineligible articles before extracting data from full eligible studies Data were extracted using a PROFORMA Review Manager 53 RevMan was used to carry out the analysis using generic inverse variance method GIVM Change from baseline and standard deviation were utilized in random effect model to get the pooled mean difference effect Subgroup analyses were done using meta-regression in STATA to explore confounders GRADE approach was conducted to evaluate the quality of evidence and the strength of recommendations

Results Databases were searched through 04032016 and updated on 11042017 Twenty-seven studies were eligible for analyses The overall effect of viscous fibres on body weight was a significant reduction of -038 kg 95CI -03 -013 P0003 BMI waist circumference and body fat were also significantly reduced -041 kgm2 95 CI -061 -021p 00001 -078 cm95CI -133 -024 p and -128 95 CI -209 -046 p respectively

Significance This study is the first systematic review and meta-analysis that evaluated separately the effect of viscous and non-viscous fibres on weight in the general population The analysis may help guide diet recommendations for obesity and identify the effect of fibres to direct future research this area

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: False
Is an FDA AA801 Violation?: None