Trial Outcomes & Findings for Evaluation of Pulse Fibre Supplementation on Obesity and the Metabolic Syndrome (NCT NCT01719900)

NCT ID: NCT01719900

Last Updated: 2020-01-21

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 53 participants
• Primary outcome timeframe: Value at 12 weeks minus value at baseline
• Results posted on: 2020-01-21

Participant Flow

Participant milestones

Measure	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. Pulse fibre: Yellow pea hull fibre incorporated into a biscuit at 5 g/serving.	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. Control: Control biscuit with no yellow pea hull fibre.
Overall Study STARTED	29	24
Overall Study COMPLETED	22	22
Overall Study NOT COMPLETED	7	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluation of Pulse Fibre Supplementation on Obesity and the Metabolic Syndrome

Baseline characteristics by cohort

Measure	Pulse Fibre n=29 Participants 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. Pulse fibre: Yellow pea hull fibre incorporated into a biscuit at 5 g/serving.	Control n=24 Participants 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. Control: Control biscuit with no yellow pea hull fibre.	Total n=53 Participants Total of all reporting groups
Age, Continuous	43.5 years STANDARD_DEVIATION 8.1 • n=5 Participants	44.3 years STANDARD_DEVIATION 9.5 • n=7 Participants	43.9 years STANDARD_DEVIATION 14.5 • n=5 Participants
Sex: Female, Male Female	23 Participants n=5 Participants	20 Participants n=7 Participants	43 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	4 Participants n=7 Participants	10 Participants n=5 Participants
Region of Enrollment Canada	29 participants n=5 Participants	24 participants n=7 Participants	53 participants n=5 Participants

PRIMARY outcome

Timeframe: Value at 12 weeks minus value at baseline

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

Outcome measures

Measure	Pulse Fibre n=22 Participants 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. Pulse fibre: Yellow pea hull fibre incorporated into a biscuit at 5 g/serving.	Control n=22 Participants 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. Control: Control biscuit with no yellow pea hull fibre.
Change in Fat Mass at 12 Weeks	-0.74 kg Standard Error 0.26	0.42 kg Standard Error 0.38

SECONDARY outcome

Timeframe: 12 weeks

Assessed via HbA1c

Outcome measures

Measure	Pulse Fibre n=22 Participants 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. Pulse fibre: Yellow pea hull fibre incorporated into a biscuit at 5 g/serving.	Control n=22 Participants 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. Control: Control biscuit with no yellow pea hull fibre.
HbA1c at 12 Weeks	5.68 % in blood Standard Error 0.11	5.89 % in blood Standard Error 0.11

SECONDARY outcome

Timeframe: 12 weeks minus baseline

Value at 12 weeks minus baseline energy intake during weighed lunch buffet.

Outcome measures

Measure	Pulse Fibre n=22 Participants 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. Pulse fibre: Yellow pea hull fibre incorporated into a biscuit at 5 g/serving.	Control n=22 Participants 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. Control: Control biscuit with no yellow pea hull fibre.
Change in Objective Appetite at 12 Weeks	-16 % of baseline food intake Standard Error 6	5 % of baseline food intake Standard Error 5

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 weeks

Serum LDL (low density lipoprotein) cholesterol

Outcome measures

Measure	Pulse Fibre n=22 Participants 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. Pulse fibre: Yellow pea hull fibre incorporated into a biscuit at 5 g/serving.	Control n=22 Participants 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. Control: Control biscuit with no yellow pea hull fibre.
Cholesterol Profile at 12 Weeks	2.92 mmol/l Standard Error .22	2.90 mmol/l Standard Error .21

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 weeks

Serum cytokine IL-6 measured at 12 weeks

Outcome measures

Measure	Pulse Fibre n=22 Participants 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. Pulse fibre: Yellow pea hull fibre incorporated into a biscuit at 5 g/serving.	Control n=22 Participants 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. Control: Control biscuit with no yellow pea hull fibre.
Serum Cytokine at 12 Weeks	0.89 pg/ml Standard Error 0.20	1.28 pg/ml Standard Error 0.29

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Measure	Pulse Fibre n=22 Participants 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. Pulse fibre: Yellow pea hull fibre incorporated into a biscuit at 5 g/serving.	Control n=22 Participants 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. Control: Control biscuit with no yellow pea hull fibre.
Alpha Diversity of Gut Microbiota at 12 Weeks	493 Score on a scale of 1-4000 Standard Error 132	512 Score on a scale of 1-4000 Standard Error 117

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Measure	Pulse Fibre n=22 Participants 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. Pulse fibre: Yellow pea hull fibre incorporated into a biscuit at 5 g/serving.	Control n=22 Participants 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. Control: Control biscuit with no yellow pea hull fibre.
Serum Metabolomics at 12 Weeks	27 score on a scale of 1-100%	27 score on a scale of 1-100%

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 weeks

Fecal acetate concentration measured at 12 weeks

Outcome measures

Measure	Pulse Fibre n=16 Participants 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. Pulse fibre: Yellow pea hull fibre incorporated into a biscuit at 5 g/serving.	Control n=18 Participants 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. Control: Control biscuit with no yellow pea hull fibre.
Fecal Short-chain Fatty Acid Concentrations	112.7 µmol/g dry weight Standard Error 15.5	82.99 µmol/g dry weight Standard Error 12.97

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 weeks

Fecal cholic acid concentration measured at 12 weeks

Outcome measures

Measure	Pulse Fibre n=16 Participants 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. Pulse fibre: Yellow pea hull fibre incorporated into a biscuit at 5 g/serving.	Control n=18 Participants 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. Control: Control biscuit with no yellow pea hull fibre.
Fecal Bile Acid Concentration	1.38 µmol/g dry weight Standard Error 0.14	1.99 µmol/g dry weight Standard Error 0.20

Adverse Events

Pulse Fibre

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Raylene Reimer

University of Calgary

Phone: 14032208218

Email: reimer@ucalgary.ca

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place