Obesity
Conditions
Keywords
Dietary intervention, Dietary fibre, Obesity, Metabolic syndrome, Weight loss, Glucose regulation, Pulse fibre
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.
Interventions
DIETARY_SUPPLEMENTPulse fibre
Yellow pea hull fibre incorporated into a biscuit at 5 g/serving.
DIETARY_SUPPLEMENTControl
Control biscuit with no yellow pea hull fibre.
Sponsors
Alberta Innovates Health Solutions
Alberta Innovates Bio Solutions
Alberta Pulse Growers
University of Calgary
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| HbA1c at 12 Weeks | 12 weeks | Assessed via HbA1c |
| Change in Objective Appetite at 12 Weeks | 12 weeks minus baseline | Value at 12 weeks minus baseline energy intake during weighed lunch buffet. |
Other
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Cholesterol Profile at 12 Weeks | 12 weeks | Serum LDL (low density lipoprotein) cholesterol |
| Fecal Bile Acid Concentration | 12 weeks | Fecal cholic acid concentration measured at 12 weeks |
| Fecal Short-chain Fatty Acid Concentrations | 12 weeks | Fecal acetate concentration measured at 12 weeks |
| Serum Cytokine at 12 Weeks | 12 weeks | Serum cytokine IL-6 measured at 12 weeks |
| 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. |
Countries
Canada
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 29 |
| 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. | 24 |
| Total | 53 |
Baseline characteristics
| Characteristic | Pulse Fibre | Control | Total |
|---|---|---|---|
| Age, Continuous | 43.5 years STANDARD_DEVIATION 8.1 | 44.3 years STANDARD_DEVIATION 9.5 | 43.9 years STANDARD_DEVIATION 14.5 |
| Region of Enrollment Canada | 29 participants | 24 participants | 53 participants |
| Sex: Female, Male Female | 23 Participants | 20 Participants | 43 Participants |
| Sex: Female, Male Male | 6 Participants | 4 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 29 | 0 / 24 |
| other Total, other adverse events | 0 / 29 | 0 / 24 |
| serious Total, serious adverse events | 0 / 29 | 0 / 24 |
Outcome results
Primary
Change in Fat Mass at 12 Weeks
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pulse Fibre | Change in Fat Mass at 12 Weeks | -0.74 kg | Standard Error 0.26 |
| Control | Change in Fat Mass at 12 Weeks | 0.42 kg | Standard Error 0.38 |
Secondary
Change in Objective Appetite at 12 Weeks
Value at 12 weeks minus baseline energy intake during weighed lunch buffet.
Time frame: 12 weeks minus baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pulse Fibre | Change in Objective Appetite at 12 Weeks | -16 % of baseline food intake | Standard Error 6 |
| Control | Change in Objective Appetite at 12 Weeks | 5 % of baseline food intake | Standard Error 5 |
Secondary
HbA1c at 12 Weeks
Assessed via HbA1c
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pulse Fibre | HbA1c at 12 Weeks | 5.68 % in blood | Standard Error 0.11 |
| Control | HbA1c at 12 Weeks | 5.89 % in blood | Standard Error 0.11 |
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.
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pulse Fibre | Alpha Diversity of Gut Microbiota at 12 Weeks | 493 Score on a scale of 1-4000 | Standard Error 132 |
| Control | Alpha Diversity of Gut Microbiota at 12 Weeks | 512 Score on a scale of 1-4000 | Standard Error 117 |
Other Pre-specified
Cholesterol Profile at 12 Weeks
Serum LDL (low density lipoprotein) cholesterol
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pulse Fibre | Cholesterol Profile at 12 Weeks | 2.92 mmol/l | Standard Error 0.22 |
| Control | Cholesterol Profile at 12 Weeks | 2.90 mmol/l | Standard Error 0.21 |
Other Pre-specified
Fecal Bile Acid Concentration
Fecal cholic acid concentration measured at 12 weeks
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pulse Fibre | Fecal Bile Acid Concentration | 1.38 µmol/g dry weight | Standard Error 0.14 |
| Control | Fecal Bile Acid Concentration | 1.99 µmol/g dry weight | Standard Error 0.2 |
Other Pre-specified
Fecal Short-chain Fatty Acid Concentrations
Fecal acetate concentration measured at 12 weeks
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pulse Fibre | Fecal Short-chain Fatty Acid Concentrations | 112.7 µmol/g dry weight | Standard Error 15.5 |
| Control | Fecal Short-chain Fatty Acid Concentrations | 82.99 µmol/g dry weight | Standard Error 12.97 |
Other Pre-specified
Serum Cytokine at 12 Weeks
Serum cytokine IL-6 measured at 12 weeks
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pulse Fibre | Serum Cytokine at 12 Weeks | 0.89 pg/ml | Standard Error 0.2 |
| Control | Serum Cytokine at 12 Weeks | 1.28 pg/ml | Standard Error 0.29 |
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.
Time frame: 12 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pulse Fibre | Serum Metabolomics at 12 Weeks | 27 score on a scale of 1-100% |
| Control | Serum Metabolomics at 12 Weeks | 27 score on a scale of 1-100% |