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| Name | Class |
|---|---|
| Alberta Innovates Health Solutions | OTHER |
| Alberta Innovates Bio Solutions | OTHER |
| Alberta Pulse Growers | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pulse fibre | Dietary Supplement | Yellow pea hull fibre incorporated into a biscuit at 5 g/serving. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c at 12 Weeks | Assessed via HbA1c | 12 weeks |
| Change in Objective Appetite at 12 Weeks | Value at 12 weeks minus baseline energy intake during weighed lunch buffet. |
| Measure | Description | Time Frame |
|---|---|---|
| Cholesterol Profile at 12 Weeks | Serum LDL (low density lipoprotein) cholesterol | 12 weeks |
| Serum Cytokine at 12 Weeks | Serum cytokine IL-6 measured at 12 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Raylene Reimer, PhD, RD | University of Calgary | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Calgary | Calgary | Alberta | T2N 1N4 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24712378 | Background | 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. | |
| 26811130 | Result | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Control |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Fat Mass at 12 Weeks | Value at 12 weeks minus value at baseline assessed with dual energy x-ray absorptiometry. | Posted | Mean | Standard Error | kg | Value at 12 weeks minus value at baseline |
|
12 weeks
53 assessed for serious adverse events
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Raylene Reimer | University of Calgary | 14032208218 | reimer@ucalgary.ca |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D024821 | Metabolic Syndrome |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| Control | Dietary Supplement | Control biscuit with no yellow pea hull fibre. |
|
| 12 weeks minus baseline |
| 12 weeks |
| 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 |
| 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 |
| Fecal Short-chain Fatty Acid Concentrations | Fecal acetate concentration measured at 12 weeks | 12 weeks |
| Fecal Bile Acid Concentration | Fecal cholic acid concentration measured at 12 weeks | 12 weeks |
| 30572270 | 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. |
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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | HbA1c at 12 Weeks | Assessed via HbA1c | Posted | Mean | Standard Error | % in blood | 12 weeks |
|
|
|
| Secondary | Change in Objective Appetite at 12 Weeks | Value at 12 weeks minus baseline energy intake during weighed lunch buffet. | Posted | Mean | Standard Error | % of baseline food intake | 12 weeks minus baseline |
|
|
|
| Other Pre-specified | Cholesterol Profile at 12 Weeks | Serum LDL (low density lipoprotein) cholesterol | Posted | Mean | Standard Error | mmol/l | 12 weeks |
|
|
|
| Other Pre-specified | Serum Cytokine at 12 Weeks | Serum cytokine IL-6 measured at 12 weeks | Posted | Mean | Standard Error | pg/ml | 12 weeks |
|
|
|
| Other Pre-specified | 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. | Posted | Mean | Standard Error | Score on a scale of 1-4000 | 12 weeks |
|
|
|
| Other Pre-specified | 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. | Posted | Number | score on a scale of 1-100% | 12 weeks |
|
|
|
| Other Pre-specified | Fecal Short-chain Fatty Acid Concentrations | Fecal acetate concentration measured at 12 weeks | Posted | Mean | Standard Error | µmol/g dry weight | 12 weeks |
|
|
|
| Other Pre-specified | Fecal Bile Acid Concentration | Fecal cholic acid concentration measured at 12 weeks | Posted | Mean | Standard Error | µmol/g dry weight | 12 weeks |
|
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|
| 0 |
| 29 |
| 0 |
| 29 |
| 0 |
| 29 |
| EG001 | 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. | 0 | 24 | 0 | 24 | 0 | 24 |
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D001836 | Body Weight Changes |