Evaluation of Pulse Fibre Supplementation on Obesity and the Metabolic Syndrome

Study Overview
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Brief Summary
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The recent dramatic increase in obesity has been linked to a reduction of dietary fibre intake. We hypothesized that supplementing the diet of overweight and obesity adults with pulse fibre will improve their metabolic status, chiefly defined as greater weight loss. Other metabolic health improvements may include improved glucose control and reduced inflammatory markers.

Detailed Description
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The main objective of our study is to assess the effects of pulse fibre supplementation on weight loss in an overweight and obese adult population. Primary objective - To determine the effects of a 12 week intake of 15g/day of pea hull fibre on weight loss supported by body composition measures. Secondary objective - To measure glucose control and appetite regulation in overweight and obese adults consuming 15g/day of pea hull fibre compared to a placebo control with the use of plasma HbA1c and an oral glucose tolerance test (OGTT). Tertiary objective - To examine mechanisms of action of pulse fibre supplementation by determining the impact of pulse fibre supplementation on gut microbiota, serum metabolomics and fecal short-chain fatty acid and bile acid concentrations.

Official Title
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Evaluation of Pulse Fibre Supplementation in Obesity and the Metabolic Syndrome: Generating Evidence in Support of Health Claims

Conditions
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Obesity

Intervention / Treatment
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* Dietary Supplement: Pulse fibre
* Dietary Supplement: Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males and females Age 18 - 70 years BMI 25 - 38 kg/m-2 Stable body weight for at least 3 months prior to the study Exclusion Criteria: Concomitant use of any weight loss medication, diet or exercise regime Use of corticosteroids, anti-depressants, anti-epileptic medications, lipid lowering medication, diabetes medications Previous bariatric or other intestinal surgeries Pregnancy or lactation Weight loss > 3 kg within preceding 3 months to enrollment Use of bulk laxatives or probiotics/prebiotics supplements Antibiotic use in the past month Clinically significant cardiovascular or respiratory or liver disease

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pulse Fibre<br>The intervention group will receive a biscuit containing 5g/serving of yellow pea fibre to be eaten 3 times per day approximately 30 minutes prior to their 3 largest meals. | Dietary Supplement: Pulse fibre<br>* Yellow pea hull fibre incorporated into a biscuit at 5 g/serving.<br>|
| Placebo Comparator: Control<br>The placebo group will receive a biscuit an isocaloric control biscuit that is similar in taste and texture and without pulse fibre to be eaten 3 times per day approximately 30 minutes prior to their 3 largest meals. | Dietary Supplement: Control<br>* Control biscuit with no yellow pea hull fibre.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Fat Mass at 12 Weeks | Value at 12 weeks minus value at baseline assessed with dual energy x-ray absorptiometry. | Value at 12 weeks minus value at baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c at 12 Weeks | Assessed via HbA1c | 12 weeks | 
| Change in Objective Appetite at 12 Weeks | Value at 12 weeks minus baseline energy intake during weighed lunch buffet. | 12 weeks minus baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dietary intervention, Dietary fibre, Obesity, Metabolic syndrome, Weight loss, Glucose regulation, Pulse fibre