Clinical trial NCT01719900: 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
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Dietary intervention
Dietary fibre
Obesity
Metabolic syndrome
Weight loss
Glucose regulation
Pulse fibre
Lead sponsor: University of Calgary
Sponsor class: OTHER
Collaborators: name: Alberta Innovates Health Solutions
name: Alberta Innovates Bio Solutions
name: Alberta Pulse Growers
First posted: 2012-11-01
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in Fat Mass at 12 Weeks
timeFrame: Value at 12 weeks minus value at baseline
Secondary outcomes:
measure: HbA1c at 12 Weeks
timeFrame: 12 weeks
measure: Change in Objective Appetite at 12 Weeks
timeFrame: 12 weeks minus baseline
Other outcomes:
measure: Cholesterol Profile at 12 Weeks
timeFrame: 12 weeks
measure: Serum Cytokine at 12 Weeks
timeFrame: 12 weeks
measure: Alpha Diversity of Gut Microbiota at 12 Weeks
timeFrame: 12 weeks
measure: Serum Metabolomics at 12 Weeks
timeFrame: 12 weeks
measure: Fecal Short-chain Fatty Acid Concentrations
timeFrame: 12 weeks
measure: Fecal Bile Acid Concentration
timeFrame: 12 weeks
Locations:
city: Calgary
country: Canada
facility: University of Calgary
state: Alberta
Study officials:
affiliation: University of Calgary
name: Raylene Reimer, PhD, RD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.