Evaluation of Pulse Fibre Supplementation on Obesity and the Metabolic Syndrome
This study is ongoing, but not recruiting participants.
Sponsor:
University of Calgary
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
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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
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
| 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 May 19, 2013