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Completed

NCT Number: NCT01719900

Evaluation of Pulse Fibre Supplementation on Obesity and the Metabolic Syndrome

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.

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Key information

Conditions

Obesity Body Weight Body Weight Changes Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Metabolic Syndrome Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Loss

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Calgary

Calgary, Alberta, T2N 1N4, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pulse fibre

Dietary Supplement

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

Control

Dietary Supplement

Control biscuit with no yellow pea hull fibre.

Primary outcomes

  1. Change in Fat Mass at 12 Weeks

    Time frame: Value at 12 weeks minus value at baseline

    Value at 12 weeks minus value at baseline assessed with dual energy x-ray absorptiometry.

Secondary outcomes

  1. HbA1c at 12 Weeks

    Time frame: 12 weeks

    Assessed via HbA1c

  2. Change in Objective Appetite at 12 Weeks

    Time frame: 12 weeks minus baseline

    Value at 12 weeks minus baseline energy intake during weighed lunch buffet.

Other outcomes

  1. Cholesterol Profile at 12 Weeks

    Time frame: 12 weeks

    Serum LDL (low density lipoprotein) cholesterol

  2. Serum Cytokine at 12 Weeks

    Time frame: 12 weeks

    Serum cytokine IL-6 measured at 12 weeks

  3. Alpha Diversity of Gut Microbiota at 12 Weeks

    Time frame: 12 weeks

    Gut microbiota alpha diversity measured at 12 weeks as Chao index. Chao index is an abundance-based estimator of species richness within a sample. There are no preset minimum and maximum values but scores typically range from 0 to 4000. A higher score is generally regarded as better.

  4. Serum Metabolomics at 12 Weeks

    Time frame: 12 weeks

    Serum metabolomics measured at 12 weeks using 1H-NMR analysis. Principal component analysis is used to see if two or more groups of samples separate into distinct clusters. The principal components generated in this analysis range from 0-100%. A higher value means that more variability among the samples is explained by this principal component.

  5. Fecal Short-chain Fatty Acid Concentrations

    Time frame: 12 weeks

    Fecal acetate concentration measured at 12 weeks

  6. Fecal Bile Acid Concentration

    Time frame: 12 weeks

    Fecal cholic acid concentration measured at 12 weeks

Sponsors and collaborators

Lead sponsor

University of Calgary

Other

Collaborators

  • Alberta Innovates Bio Solutions
  • Alberta Innovates Health Solutions
  • Alberta Pulse Growers

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2018
First posted
Nov 1, 2012
Registry last updated
Jan 21, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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