Evaluation of Pulse Fibre Supplementation on Obesity and the Metabolic Syndrome

• Sponsor: University of Calgary (Other)
• Overall Status: Completed
• CT.gov ID: NCT01719900
• Collaborator: Alberta Innovates Health Solutions (Other), Alberta Innovates Bio Solutions (Other), Alberta Pulse Growers (Other)
• Enrollment: 53
• Location: 1
• Arms: 2
• Duration (Months): 73.8
• Patients Per Site Per Month: 0.7

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Obesity	Dietary Supplement: Pulse fibre; Dietary Supplement: Control	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 53 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Evaluation of Pulse Fibre Supplementation in Obesity and the Metabolic Syndrome: Generating Evidence in Support of Health Claims
• Study Start Date: Oct 1, 2012
• Actual Primary Completion Date: May 1, 2013
• Actual Study Completion Date: Nov 26, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Dietary Supplement: Pulse fibre; Yellow pea hull fibre incorporated into a biscuit at 5 g/serving.
Placebo Comparator: 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.	Dietary Supplement: Control; Control biscuit with no yellow pea hull fibre.

Outcome Measures

Primary Outcome Measures

1. Change in Fat Mass at 12 Weeks [Value at 12 weeks minus value at baseline]

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

Secondary Outcome Measures

1. HbA1c at 12 Weeks [12 weeks]

   Assessed via HbA1c

2. Change in Objective Appetite at 12 Weeks [12 weeks minus baseline]

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

Other Outcome Measures

1. Cholesterol Profile at 12 Weeks [12 weeks]

   Serum LDL (low density lipoprotein) cholesterol

2. Serum Cytokine at 12 Weeks [12 weeks]

   Serum cytokine IL-6 measured at 12 weeks

3. Alpha Diversity of Gut Microbiota at 12 Weeks [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.

4. Serum Metabolomics at 12 Weeks [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.

5. Fecal Short-chain Fatty Acid Concentrations [12 weeks]

   Fecal acetate concentration measured at 12 weeks

6. Fecal Bile Acid Concentration [12 weeks]

   Fecal cholic acid concentration measured at 12 weeks

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Calgary	Calgary	Alberta	Canada	T2N 1N4

Sponsors and Collaborators

• University of Calgary
• Alberta Innovates Health Solutions
• Alberta Innovates Bio Solutions
• Alberta Pulse Growers

Investigators

• Principal Investigator: Raylene Reimer, PhD, RD, University of Calgary

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.

• Responsible Party: Dr. Raylene Reimer, Professor, Faculty of Kinesiology, University of Calgary
• ClinicalTrials.gov Identifier: NCT01719900
• Other Study ID Numbers: 24804
• First Posted: Nov 1, 2012
• Last Update Posted: Jan 21, 2020
• Last Verified: Jan 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Dr. Raylene Reimer, Professor, Faculty of Kinesiology, University of Calgary: Dietary intervention; Dietary fibre; Obesity; Metabolic syndrome; Weight loss; Glucose regulation; Pulse fibre
• Additional relevant MeSH terms: Obesity; Metabolic Syndrome

Study Results

Participant Flow

Arm/Group Title	Pulse Fibre	Control
Arm/Group 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. Pulse fibre: Yellow pea hull fibre incorporated into a biscuit at 5 g/serving.	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.
Period Title: Overall Study
STARTED	29	24
COMPLETED	22	22
NOT COMPLETED	7	2

Baseline Characteristics

Arm/Group Title	Pulse Fibre	Control	Total
Arm/Group 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. Pulse fibre: Yellow pea hull fibre incorporated into a biscuit at 5 g/serving.	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 of all reporting groups
Overall Participants	29	24	53
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	43.5 (8.1)	44.3 (9.5)	43.9 (14.5)
Sex: Female, Male (Count of Participants)
Female	23 79.3%	20 83.3%	43 81.1%
Male	6 20.7%	4 16.7%	10 18.9%
Region of Enrollment (participants) [Number]
Canada	29 100%	24 100%	53 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Pulse Fibre	Control
Arm/Group 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. Pulse fibre: Yellow pea hull fibre incorporated into a biscuit at 5 g/serving.	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.
Measure Participants	22	22
Mean (Standard Error) [kg]	-0.74 (0.26)	0.42 (0.38)

2. Secondary Outcome

Title	HbA1c at 12 Weeks
Description	Assessed via HbA1c
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Pulse Fibre	Control
Arm/Group 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. Pulse fibre: Yellow pea hull fibre incorporated into a biscuit at 5 g/serving.	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.
Measure Participants	22	22
Mean (Standard Error) [% in blood]	5.68 (0.11)	5.89 (0.11)

3. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Pulse Fibre	Control
Arm/Group 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. Pulse fibre: Yellow pea hull fibre incorporated into a biscuit at 5 g/serving.	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.
Measure Participants	22	22
Mean (Standard Error) [% of baseline food intake]	-16 (6)	5 (5)

4. Other Pre-specified Outcome

Title	Cholesterol Profile at 12 Weeks
Description	Serum LDL (low density lipoprotein) cholesterol
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Pulse Fibre	Control
Arm/Group 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. Pulse fibre: Yellow pea hull fibre incorporated into a biscuit at 5 g/serving.	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.
Measure Participants	22	22
Mean (Standard Error) [mmol/l]	2.92 (.22)	2.90 (.21)

5. Other Pre-specified Outcome

Title	Serum Cytokine at 12 Weeks
Description	Serum cytokine IL-6 measured at 12 weeks
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Pulse Fibre	Control
Arm/Group 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. Pulse fibre: Yellow pea hull fibre incorporated into a biscuit at 5 g/serving.	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.
Measure Participants	22	22
Mean (Standard Error) [pg/ml]	0.89 (0.20)	1.28 (0.29)

6. Other Pre-specified Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Pulse Fibre	Control
Arm/Group 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. Pulse fibre: Yellow pea hull fibre incorporated into a biscuit at 5 g/serving.	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.
Measure Participants	22	22
Mean (Standard Error) [Score on a scale of 1-4000]	493 (132)	512 (117)

7. Other Pre-specified Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Pulse Fibre	Control
Arm/Group 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. Pulse fibre: Yellow pea hull fibre incorporated into a biscuit at 5 g/serving.	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.
Measure Participants	22	22
Number [score on a scale of 1-100%]	27	27

8. Other Pre-specified Outcome

Title	Fecal Short-chain Fatty Acid Concentrations
Description	Fecal acetate concentration measured at 12 weeks
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Pulse Fibre	Control
Arm/Group 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. Pulse fibre: Yellow pea hull fibre incorporated into a biscuit at 5 g/serving.	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.
Measure Participants	16	18
Mean (Standard Error) [µmol/g dry weight]	112.7 (15.5)	82.99 (12.97)

9. Other Pre-specified Outcome

Title	Fecal Bile Acid Concentration
Description	Fecal cholic acid concentration measured at 12 weeks
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Pulse Fibre	Control
Arm/Group 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. Pulse fibre: Yellow pea hull fibre incorporated into a biscuit at 5 g/serving.	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.
Measure Participants	16	18
Mean (Standard Error) [µmol/g dry weight]	1.38 (0.14)	1.99 (0.20)

Adverse Events

Time Frame	12 weeks
Adverse Event Reporting Description	53 assessed for serious adverse events
Arm/Group Title	Pulse Fibre		Control
Arm/Group 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. Pulse fibre: Yellow pea hull fibre incorporated into a biscuit at 5 g/serving.		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.
All Cause Mortality
	Pulse Fibre		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/29 (0%)		0/24 (0%)
Serious Adverse Events
	Pulse Fibre		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/29 (0%)		0/24 (0%)
Other (Not Including Serious) Adverse Events
	Pulse Fibre		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/29 (0%)		0/24 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.