Evaluation of Pulse Fibre Supplementation on Obesity and the Metabolic Syndrome

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

53 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2018-11-26

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Meta-analysis of Soluble Fiber Consumption on Body Weight, Glycemia, and Insulinemia in Overweight and Obese Adults.

NCT03003897

Obesity

COMPLETED

Effect of Viscous Soluble Fibres on Body Weight

NCT03257449

Overweight and Obesity T2DM (Type 2 Diabetes Mellitus) General Population

UNKNOWN

The Effects of Glucomannan on Weight Loss

NCT01709955

Obesity

COMPLETED PHASE1

The Effect of a Nutritional Supplement on Post Prandial Glucose and Lipids in an Adult Population

NCT02119325

Impaired Fasting Glucose

COMPLETED NA

Anti-inflammatory Effects of Fiber

NCT02781350

Postprandial Inflammation

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Obesity

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Pulse fibre

Intervention Type DIETARY_SUPPLEMENT

Yellow pea hull fibre incorporated into a biscuit at 5 g/serving.

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.

Group Type PLACEBO_COMPARATOR

Control

Intervention Type DIETARY_SUPPLEMENT

Control biscuit with no yellow pea hull fibre.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Pulse fibre

Yellow pea hull fibre incorporated into a biscuit at 5 g/serving.

Intervention Type DIETARY_SUPPLEMENT

Control

Control biscuit with no yellow pea hull fibre.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes