Evaluation of Pulse Fibre Supplementation on Obesity and the Metabolic Syndrome

Obesity Clinical Trial

Official title:

Evaluation of Pulse Fibre Supplementation in Obesity and the Metabolic Syndrome: Generating Evidence in Support of Health Claims

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01719900
• Other study ID #: 24804
• Status: Completed
• Phase: N/A
• Start date: October 2012
• Est. completion date: November 26, 2018

Study information

• Verified date: January 2020
• Source: University of Calgary
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: November 26, 2018
• Est. primary completion date: May 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Metabolic Syndrome
• Obesity

Intervention

Dietary Supplement:
• Pulse fibre
Yellow pea hull fibre incorporated into a biscuit at 5 g/serving.
• Control
Control biscuit with no yellow pea hull fibre.

Locations

Country	Name	City	State
Canada	University of Calgary	Calgary	Alberta

Sponsors (4)

Lead Sponsor	Collaborator
University of Calgary	Alberta Innovates Bio Solutions, Alberta Innovates Health Solutions, Alberta Pulse Growers

Country where clinical trial is conducted

Canada, 

References & 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. — View 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: — View 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 Bioc — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Cholesterol Profile at 12 Weeks	Serum LDL (low density lipoprotein) cholesterol	12 weeks
Other	Serum Cytokine at 12 Weeks	Serum cytokine IL-6 measured at 12 weeks	12 weeks
Other	Alpha Diversity of Gut Microbiota at 12 Weeks	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.	12 weeks
Other	Serum Metabolomics at 12 Weeks	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.	12 weeks
Other	Fecal Short-chain Fatty Acid Concentrations	Fecal acetate concentration measured at 12 weeks	12 weeks
Other	Fecal Bile Acid Concentration	Fecal cholic acid concentration measured at 12 weeks	12 weeks
Primary	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	HbA1c at 12 Weeks	Assessed via HbA1c	12 weeks
Secondary	Change in Objective Appetite at 12 Weeks	Value at 12 weeks minus baseline energy intake during weighed lunch buffet.	12 weeks minus baseline