Evaluation of Pulse Fibre Supplementation on Obesity and the Metabolic Syndrome

Not Applicable

Completed

• Conditions: Obesity
• Interventions: Dietary Supplement: Pulse fibre; Dietary Supplement: Control

• Registration Number: NCT01719900
• Lead Sponsor: University of Calgary

Brief Summary

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

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.

Study Timeline

• Study Start: 2012-10
• Study First Submitted: 2012-10-23
• Study First Submitted QC: 2012-10-30
• Study First Posted: 2012-11-01
• Primary Completion: 2013-05
• Study Completion: 2018-11-26
• Results First Submitted: 2019-04-15
• Status Verified: 2020-01
• Results First Submitted QC: 2020-01-16
• Last Update Submitted: 2020-01-16
• Results First Posted: 2020-01-21
• Last Update Posted: 2020-01-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 53

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pulse Fibre	Pulse fibre	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.
Control	Control	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.

Primary Outcome Measures

Name	Time	Method
Change in Fat Mass at 12 Weeks	Value at 12 weeks minus value at baseline	Value at 12 weeks minus value at baseline assessed with dual energy x-ray absorptiometry.

Secondary Outcome Measures

Name	Time	Method
HbA1c at 12 Weeks	12 weeks	Assessed via HbA1c
Change in Objective Appetite at 12 Weeks	12 weeks minus baseline	Value at 12 weeks minus baseline energy intake during weighed lunch buffet.

Trial Locations

Locations (1)

University of Calgary; 🇨🇦 Calgary, Alberta, Canada