N/A
N=53
Evaluation of Pulse Fibre Supplementation on Obesity and the Metabolic Syndrome
Obesity
Bottom Line
View on ClinicalTrials.gov: NCT01719900 ↗Enrolled (actual)
53
Serious AEs
0.0%
Results posted
Jan 2020
Primary outcome: Primary: Change in Fat Mass at 12 Weeks — -0.74; 0.42 kg
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Pulse fibre (Dietary_supplement); Control (Dietary_supplement)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Calgary
- Primary completion
- May 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Fat Mass at 12 Weeks |
-0.74; 0.42 | — |
| SECONDARY HbA1c at 12 Weeks |
5.68; 5.89 | — |
| SECONDARY Change in Objective Appetite at 12 Weeks |
-16; 5 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT01719900). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.