Evaluation of Pulse Fibre Supplementation on Obesity and the Metabolic Syndrome

University of Calgary

Status: Completed

Conditions: Obesity

Treatments: Dietary Supplement: Pulse fibre; Dietary Supplement: Control

Study type: Interventional

Funder types: Other

Identifiers

NCT01719900

24804

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 53 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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53 participants in 2 patient groups, including a placebo group

Pulse Fibre

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Pulse fibre

Control

Placebo Comparator group

Description:

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.

Treatment:

Dietary Supplement: Control