ClinicalTrials.gg
Status unknownNCT03257449Updated Aug 22, 2017

Effect of Viscous Soluble Fibres on Body Weight

An observational study in Overweight and Obesity, T2DM (Type 2 Diabetes Mellitus) and General Population, sponsored by Unity Health Toronto. Status unknown at 1 site in Canada. Per ClinicalTrials.gov, last updated 2017-08-22.

Primary conditionObesityRegistry: OverweightReclassifiedWhy we changed it
Registry
Overweight — the first condition term the registry derived for this study.
ClinicalTrials.gg
Obesity
Why
  1. The study's listed conditions name Obesity, a narrower term within Overweight.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Unity Health Toronto · Observational

The sponsor has not verified this record recently (last verified Aug 2017), so the status shown — last known as Active, not recruiting — may be out of date.
Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
1,268
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 574 studies in Obesity with a site in Canada — 101 open to participants now, 150 under way, 46 of them phase 3. Obesity · Canada.

Planned enrollment
11th of 91
1,268 · median 52
Started
2016
with 20 others
Observational
91 of 574
16 open now
Registered
270th of 574
by date

Among the 574 studies in Obesity with a site in Canada, this one is the 11th largest by planned enrollment of the 91 observational ones that give a count, is one of 21 that started in 2016, is one of 91 observational ones, and was the 270th registered.

Obesity

11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.

Browse Obesity studies →

Open to participants now

101 of the 574 studies in Obesity with a site in Canada are open now. Recruiting first, the newest first:

96 more — sign in →

All 101 open studies →

A study can be open while its sites in Canada have not opened yet or have stopped. Only those recruiting at a site in Canada →

Who these studies take

Of the 1,336 Obesity studies recruiting now, 377 (28%) set no upper age limit and 856 (64%) stop at 75 or younger; 168 take children under 18; 491 take healthy volunteers.

This study: all sexes · healthy volunteers too.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 574 studies in Obesity with a site in Canada, or all of them as a file.
02

Study 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.

Read the 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 title/abstract screening was done to exclude the ineligible articles before extracting data from full eligible studies. Data were extracted using a PROFORMA. Review Manager 5.3 (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 04/03/2016 and updated on 11/04/2017. Twenty-seven studies were eligible for analyses . The overall effect of viscous fibres on body weight was a significant reduction of -0.38 kg [95%CI: -0.3, -0.13] (P=0.003). BMI, waist circumference and body fat were also significantly reduced: -0.41 kg/m2 [95% CI: -0.61, -0.21](p = 0.0001) -0.78 cm[95%CI: -1.33, -0.24] (p = ) and -1.28 %[95% CI: -2.09, -0.46] (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.

03

Conditions studied

  • Overweight and Obesity
  • T2DM (Type 2 Diabetes Mellitus)
  • General Population

Keywords

  • Body Weight
  • Weight loss
  • BMI
  • Waist Circumference
  • Body Fat Percentage
  • Viscofiber
  • Viscous Fibres
  • supplement
04

In context

Obesity Reclassified

11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.

This study's planned enrollment of 1,268 is above the median of 114 across 2,154 observational studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

Unity Health Toronto is the lead sponsor of 447 studies on the registry; 82 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 1 (20%) have results posted.

Compared within Obesity, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Overweight. The counts are of registry records indexed under each term, refreshed daily. How we classify →

05

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

This study includes all population types.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Must be a randomized controlled clinical trial with either a parallel or cross-over design
  2. Must have a treatment period of at least 4 week.
  3. Healthy children and adults, overweight and obese individuals or individuals with diabetes were all acceptable
  4. Must have one of the selected viscous fibres, (agar, alginate, β-glucan, guar gum, pectin, polyglycoplex(PGX), Psyllium, Xanthan), as a supplemented treatment.
  5. 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.
  6. Must be appropriately controlled.
  7. Must measure one of outcomes: body weight, , waist circumference, or Body fat percentage.
  8. These Anthropometry measures can be either primary or secondary outcomes.
  9. Enough information must be provided to calculate the magnitude of effect, i.e. end of treatment measures and/or change from baseline measures
  10. Ad lipitum diet only.

Exclusion criteria

Exclusion Criteria:

  1. If the soluble fibre was not one of the selected viscous fibre or a combination.
  2. supplement where these fibers could not be isolated each one alone.
  3. If the study was insufficiently controlled, i.e. the control was another soluble fibre.
  4. If the outcome measures did not include body weight, , waist circumference, or Body fat percentage.
  5. If the intervention was a diet with no supplemented fibre.
  6. If the study provided insufficient information to calculate a magnitude of effect
  7. If the study protocol maintains baseline weight.
  8. Secondary information such as reviews, editorials, commentaries, were excluded
  9. If the diet is hypo-caloric, energy restricted diet, or metabolically controlled diet.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

06

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
1,268 participants (estimated)
Patient registry
No

Interventions

  • Dietary supplementViscous Fibre

    Meta-analysis of Randomized Controlled Trials

07

What researchers measure

Primary outcomes

  1. Body weight chang

    unit of measure: Kg

    Time frame: in 4 weeks or more

  2. BMI change

    unit of measure: Kg/m2

    Time frame: in 4 weeks or more

  3. Waist circumference change

    unit of measure: Cm

    Time frame: in 4 weeks or more

  4. Body fat percentage change

    unit of measure: %

    Time frame: in 4 weeks or more

08

Study locations

1 site
  • The Toronto 3D Knowledge Synthesis and Clinical Trials Unit, Clinical Nutrition and Risk Factor Modification Centre
    Toronto, Ontario M5C 2T2, Canada
09

References and documents

Publications

  • 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. PubMed 32198674 ↗
  • 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. PubMed 31897475 ↗
10

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Mar 2016, a primary completion of Nov 2017 and a completion of Nov 2017. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 17, 2017
First posted
Aug 22, 2017
Start
Mar 2016
Primary completionEst.
Nov 2017
CompletionEst.
Nov 2017
Last update
Aug 22, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 22, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03257449
Responsible party
Sponsor
First posted
Aug 22, 2017
Start date
Mar 2016
Primary completion
Nov 2017 (estimated)
Completion
Nov 2017 (estimated)
Last update
Aug 22, 2017

Study contacts

Nourah Mazhar, MSc (C)
study director · St.Michael Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.

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