Evaluation of Pulse Fibre Supplementation on Obesity and the Metabolic Syndrome

NCT01719900 | Completed Results DMC

• 1 other identifier: 24804
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Keywords

Dietary intervention; Dietary fibre; Obesity; Metabolic syndrome; Weight loss; Glucose regulation; Pulse fibre

Outcome Measures

Primary Outcomes (1)

• Change in Fat Mass at 12 Weeks

  Value at 12 weeks minus value at baseline assessed with dual energy x-ray absorptiometry.

  Value at 12 weeks minus value at baseline

Secondary Outcomes (2)

• HbA1c at 12 Weeks

  12 weeks

• Change in Objective Appetite at 12 Weeks

  12 weeks minus baseline

Other Outcomes (6)

• Cholesterol Profile at 12 Weeks

  12 weeks

• Serum Cytokine at 12 Weeks

  12 weeks

• Alpha Diversity of Gut Microbiota at 12 Weeks

  12 weeks

Study Arms (2)

Pulse Fibre

EXPERIMENTAL

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

Control

PLACEBO COMPARATOR

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

Interventions

Pulse fibre DIETARY_SUPPLEMENT

Yellow pea hull fibre incorporated into a biscuit at 5 g/serving.

Pulse Fibre

Control DIETARY_SUPPLEMENT

Control biscuit with no yellow pea hull fibre.

Control

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Calgary: lead
• Alberta Innovates Health Solutions: collaborator
• Alberta Innovates Bio Solutions: collaborator
• Alberta Pulse Growers: collaborator

Study Sites (1)

University of Calgary

Calgary, Alberta, T2N 1N4, Canada

Location

Related Publications (3)

• 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.

  PMID: 24712378 BACKGROUND

• 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.

  PMID: 26811130 RESULT

• 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.

  PMID: 30572270 RESULT

MeSH Terms

Conditions

Obesity; Metabolic Syndrome; Weight Loss

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Body Weight Changes

Results Point of Contact

• Title: Dr. Raylene Reimer
• Organization: University of Calgary

reimer@ucalgary.ca

14032208218

Study Officials

• Raylene Reimer, PhD, RD

  University of Calgary

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Faculty of Kinesiology

Study Record Dates

• First Submitted: October 23, 2012
• First Posted: November 1, 2012
• Study Start: October 1, 2012
• Primary Completion: May 1, 2013
• Study Completion: November 26, 2018
• Last Updated: January 21, 2020
• Results First Posted: January 21, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)