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Evaluation of Pulse Fibre Supplementation on Obesity and the Metabolic Syndrome

Primary Purpose

Obesity

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Pulse fibre
Control
Sponsored by
University of Calgary
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring Dietary intervention, Dietary fibre, Obesity, Metabolic syndrome, Weight loss, Glucose regulation, Pulse fibre

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Calgary

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Pulse Fibre

Control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in Fat Mass at 12 Weeks
Value at 12 weeks minus value at baseline assessed with dual energy x-ray absorptiometry.

Secondary Outcome Measures

HbA1c at 12 Weeks
Assessed via HbA1c
Change in Objective Appetite at 12 Weeks
Value at 12 weeks minus baseline energy intake during weighed lunch buffet.

Full Information

First Posted
October 23, 2012
Last Updated
January 16, 2020
Sponsor
University of Calgary
Collaborators
Alberta Innovates Health Solutions, Alberta Innovates Bio Solutions, Alberta Pulse Growers
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1. Study Identification

Unique Protocol Identification Number
NCT01719900
Brief Title
Evaluation of Pulse Fibre Supplementation on Obesity and the Metabolic Syndrome
Official Title
Evaluation of Pulse Fibre Supplementation in Obesity and the Metabolic Syndrome: Generating Evidence in Support of Health Claims
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
November 26, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Calgary
Collaborators
Alberta Innovates Health Solutions, Alberta Innovates Bio Solutions, Alberta Pulse Growers

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
Dietary intervention, Dietary fibre, Obesity, Metabolic syndrome, Weight loss, Glucose regulation, Pulse fibre

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
53 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pulse Fibre
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Pulse fibre
Intervention Description
Yellow pea hull fibre incorporated into a biscuit at 5 g/serving.
Intervention Type
Dietary Supplement
Intervention Name(s)
Control
Intervention Description
Control biscuit with no yellow pea hull fibre.
Primary Outcome Measure Information:
Title
Change in Fat Mass at 12 Weeks
Description
Value at 12 weeks minus value at baseline assessed with dual energy x-ray absorptiometry.
Time Frame
Value at 12 weeks minus value at baseline
Secondary Outcome Measure Information:
Title
HbA1c at 12 Weeks
Description
Assessed via HbA1c
Time Frame
12 weeks
Title
Change in Objective Appetite at 12 Weeks
Description
Value at 12 weeks minus baseline energy intake during weighed lunch buffet.
Time Frame
12 weeks minus baseline
Other Pre-specified Outcome Measures:
Title
Cholesterol Profile at 12 Weeks
Description
Serum LDL (low density lipoprotein) cholesterol
Time Frame
12 weeks
Title
Serum Cytokine at 12 Weeks
Description
Serum cytokine IL-6 measured at 12 weeks
Time Frame
12 weeks
Title
Alpha Diversity of Gut Microbiota at 12 Weeks
Description
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.
Time Frame
12 weeks
Title
Serum Metabolomics at 12 Weeks
Description
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.
Time Frame
12 weeks
Title
Fecal Short-chain Fatty Acid Concentrations
Description
Fecal acetate concentration measured at 12 weeks
Time Frame
12 weeks
Title
Fecal Bile Acid Concentration
Description
Fecal cholic acid concentration measured at 12 weeks
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raylene Reimer, PhD, RD
Organizational Affiliation
University of Calgary
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Calgary
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 1N4
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
24712378
Citation
Lambert JE, Parnell JA, Han J, Sturzenegger T, Paul HA, Vogel HJ, Reimer RA. Evaluation of yellow pea fibre supplementation on weight loss and the gut microbiota: a randomized controlled trial. BMC Gastroenterol. 2014 Apr 8;14:69. doi: 10.1186/1471-230X-14-69.
Results Reference
background
PubMed Identifier
26811130
Citation
Lambert JE, Parnell JA, Tunnicliffe JM, Han J, Sturzenegger T, Reimer RA. Consuming yellow pea fiber reduces voluntary energy intake and body fat in overweight/obese adults in a 12-week randomized controlled trial. Clin Nutr. 2017 Feb;36(1):126-133. doi: 10.1016/j.clnu.2015.12.016. Epub 2016 Jan 11.
Results Reference
result
PubMed Identifier
30572270
Citation
Mayengbam S, Lambert JE, Parnell JA, Tunnicliffe JM, Nicolucci AC, Han J, Sturzenegger T, Shearer J, Mickiewicz B, Vogel HJ, Madsen KL, Reimer RA. Impact of dietary fiber supplementation on modulating microbiota-host-metabolic axes in obesity. J Nutr Biochem. 2019 Feb;64:228-236. doi: 10.1016/j.jnutbio.2018.11.003. Epub 2018 Nov 26.
Results Reference
result

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Evaluation of Pulse Fibre Supplementation on Obesity and the Metabolic Syndrome

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