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Evaluation of Pulse Fibre Supplementation on Obesity and the Metabolic Syndrome

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ClinicalTrials.gov Identifier: NCT01719900
Recruitment Status : Completed
First Posted : November 1, 2012
Results First Posted : January 21, 2020
Last Update Posted : January 21, 2020
Sponsor:
Collaborators:
Alberta Innovates Health Solutions
Alberta Innovates Bio Solutions
Alberta Pulse Growers
Information provided by (Responsible Party):
Dr. Raylene Reimer, 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.

Condition or disease Intervention/treatment Phase
Obesity Dietary Supplement: Pulse fibre Dietary Supplement: Control Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 53 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Evaluation of Pulse Fibre Supplementation in Obesity and the Metabolic Syndrome: Generating Evidence in Support of Health Claims
Study Start Date : October 2012
Actual Primary Completion Date : May 2013
Actual Study Completion Date : November 26, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
Dietary Supplement: Pulse fibre
Yellow pea hull fibre incorporated into a biscuit at 5 g/serving.

Placebo Comparator: 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.
Dietary Supplement: Control
Control biscuit with no yellow pea hull fibre.




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01719900


Locations
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Canada, Alberta
University of Calgary
Calgary, Alberta, Canada, T2N 1N4
Sponsors and Collaborators
University of Calgary
Alberta Innovates Health Solutions
Alberta Innovates Bio Solutions
Alberta Pulse Growers
Investigators
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Principal Investigator: Raylene Reimer, PhD, RD University of Calgary
Publications of Results:
Other Publications:
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Responsible Party: Dr. Raylene Reimer, Professor, Faculty of Kinesiology, University of Calgary
ClinicalTrials.gov Identifier: NCT01719900    
Other Study ID Numbers: 24804
First Posted: November 1, 2012    Key Record Dates
Results First Posted: January 21, 2020
Last Update Posted: January 21, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Dr. Raylene Reimer, University of Calgary:
Dietary intervention
Dietary fibre
Obesity
Metabolic syndrome
Weight loss
Glucose regulation
Pulse fibre
Additional relevant MeSH terms:
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Obesity
Metabolic Syndrome
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases