Overweight and ObesityNCT03257449
Effect of Viscous Soluble Fibres on Body Weight
An observational study of Overweight and Obesity and T2DM (Type 2 Diabetes Mellitus), run by Unity Health Toronto at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity, T2DM (Type 2 Diabetes Mellitus), General Population
- What is being tested?
- Viscous Fibre
- How many people
- 1,268 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2016to Nov 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: This study includes all population types.
Who may be able to join
- 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.
Show all 10Show fewer
- 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.
Who cannot join
- 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
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site
The Toronto 3D Knowledge Synthesis and Clinical Trials Unit, Clinical Nutrition and Risk Factor Modification Centre
Toronto, Ontario, M5C 2T2
About this study
Official title: Effect of Viscous Soluble Fibres on Body Weight Parameters: Review and Meta-analyses
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.
Read more
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.
- Being tested
- Viscous Fibre
- Keywords
- Body Weight, Weight loss, BMI, Waist Circumference, Body Fat Percentage, Viscofiber, Viscous Fibres, supplement
- Medical subject headings
- Overweight, Obesity, Diabetes Mellitus, Type 2, Body Weight, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Viscous FibreDietary supplement
Meta-analysis of Randomized Controlled Trials
What is being measured
The primary outcome is the main question the study is designed to answer.
Body weight chang
unit of measure: Kg
Measured: in 4 weeks or more
BMI change
unit of measure: Kg/m2
Measured: in 4 weeks or more
Waist circumference change
unit of measure: Cm
Measured: in 4 weeks or more
Body fat percentage change
unit of measure: %
Measured: in 4 weeks or more
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2017
- Study startMar 2016
- Primary completionNov 2017 (estimated)
- Study completionNov 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- More trials run by Unity Health TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 1,268 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nourah Mazhar, MSc (C), Study director, St.Michael Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03257449
- Sponsor's protocol ID
- Body Weight Loss Meta
- Status last verified
- Aug 2017
- First submitted
- 17 Aug 2017
- Last updated
- 22 Aug 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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 32198674Jovanovski 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
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Viscous Soluble Fibres on Body Weight Parameters: Review and Meta-analyses
- ClinicalTrials.gov ID
- NCT03257449
- Acronym / sponsor ID
- Body Weight Loss Meta
- Keywords
- Body Weight, Weight loss, BMI, Waist Circumference, Body Fat Percentage, Viscofiber, Viscous Fibres, supplement
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,268 participants (estimated)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Nov 2017 (estimated)
- Study completion
- Nov 2017 (estimated)
- First posted
- 22 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This study includes all population types.
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Viscous FibreMeta-analysis of Randomized Controlled Trials | Dietary supplement | – |
Primary outcome
Body weight chang
Time frame: in 4 weeks or more
unit of measure: Kg
BMI change
Time frame: in 4 weeks or more
unit of measure: Kg/m2
Waist circumference change
Time frame: in 4 weeks or more
unit of measure: Cm
Body fat percentage change
Time frame: in 4 weeks or more
unit of measure: %
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2017.
- Derived from this study: PubMed 32198674Jovanovski 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.
- Derived from this study: PubMed 31897475Jovanovski 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nourah Mazhar, MSc (C) study director
St.Michael Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Overweight and Obesity and T2DM (Type 2 Diabetes Mellitus), run by Unity Health Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body weight chang (time frame: in 4 weeks or more). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03257449, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2017.