Status:
UNKNOWN
Effect of Viscous Soluble Fibres on Body Weight
Lead Sponsor:
Unity Health Toronto
Conditions:
Overweight and Obesity
T2DM (Type 2 Diabetes Mellitus)
Eligibility:
All Genders
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 manageme...
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 inve...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
March 1 2016
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
November 1 2017
Estimated Enrollment :
1268 Patients enrolled
Trial Details
Trial ID
NCT03257449
Start Date
March 1 2016
End Date
November 1 2017
Last Update
August 22 2017
Active Locations (1)
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1
The Toronto 3D Knowledge Synthesis and Clinical Trials Unit, Clinical Nutrition and Risk Factor Modification Centre
Toronto, Ontario, Canada, M5C 2T2