We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Evaluation of Pulse Fibre Supplementation on Obesity and the Metabolic Syndrome

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01719900
First Posted: November 1, 2012
Last Update Posted: October 26, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Alberta Innovates Health Solutions
Alberta Innovates Bio Solutions
Alberta Pulse Growers
Information provided by (Responsible Party):
Dr. Raylene Reimer, University of Calgary
  Purpose
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 Intervention
Obesity Dietary Supplement: Pulse fibre Dietary Supplement: Control

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Dr. Raylene Reimer, University of Calgary:

Primary Outcome Measures:
  • Change in baseline fat mass at 12 weeks [ Time Frame: 12 weeks ]
    Assessed with dual energy x-ray absorptiometry.


Secondary Outcome Measures:
  • Change in baseline glucose tolerance at 12 weeks [ Time Frame: 12 weeks ]
    Assessed via HbA1c and an oral glucose tolerance test.

  • Change in baseline appetite at 12 weeks [ Time Frame: 12 weeks ]
    Subjective appetite assessed with visual analog scales and objective appetite with a weighed lunch buffet.


Other Outcome Measures:
  • Change in baseline lipid profile at 12 weeks [ Time Frame: 12 weeks ]
    Serum lipid

  • Change in baseline inflammatory markers at 12 weeks [ Time Frame: 12 weeks ]
    Serum cytokine


Estimated Enrollment: 60
Study Start Date: October 2012
Estimated Study Completion Date: December 2017
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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).

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
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
  Contacts and Locations
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
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
Principal Investigator: Raylene Reimer, PhD, RD University of Calgary
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. Raylene Reimer, Professor, Faculty of Kinesiology, University of Calgary
ClinicalTrials.gov Identifier: NCT01719900     History of Changes
Other Study ID Numbers: 24804
First Submitted: October 23, 2012
First Posted: November 1, 2012
Last Update Posted: October 26, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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:
Obesity
Metabolic Syndrome X
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases