Evaluation of Pulse Fibre Supplementation on Obesity and the Metabolic Syndrome

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Alberta Innovates Health Solutions
Alberta Innovates - Bio Solutions
Alberta Pulse Growers Commission
Information provided by (Responsible Party):
Dr. Raylene Reimer, University of Calgary
ClinicalTrials.gov Identifier:
NCT01719900
First received: October 23, 2012
Last updated: May 10, 2013
Last verified: May 2013
  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 Phase
Obesity
Dietary Supplement: Pulse fibre
Dietary Supplement: Control
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 University of Calgary:

Primary Outcome Measures:
  • Change in baseline fat mass at 12 weeks [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Assessed with dual energy x-ray absorptiometry.


Secondary Outcome Measures:
  • Change in baseline glucose tolerance at 12 weeks [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Assessed via HbA1c and an oral glucose tolerance test.

  • Change in baseline appetite at 12 weeks [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Change in baseline inflammatory markers at 12 weeks [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: October 2012
Estimated Study Completion Date: May 2014
Estimated 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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 Commission
  More Information

No publications provided by University of Calgary

Additional 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
Study First Received: October 23, 2012
Last Updated: May 10, 2013
Health Authority: Canada: Ethics Review Committee

Keywords provided by 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

ClinicalTrials.gov processed this record on August 20, 2014