Back to resultsEffect of Protein and Prebiotic Fiber Intake on Adiposity in Overweight and Obese Adults
Primary Purpose
Obesity
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Protein
Prebiotic fiber
Protein plus prebiotic fiber
Control
Sponsored by
About this trial
This is an interventional treatment trial for Obesity focused on measuring Weight loss, Appetite, Overweight, Obesity, Dietary fiber, Dietary protein
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:
- Type 1 diabetes
- Clinically significant cardiovascular, liver or pancreas disease
- Major gastrointestinal surgeries
- Pregnant or lactating
- Concomitant use of any weight loss medication, diet or exercise regime
- Antibiotic use in the preceding 3 months to enrollment
- Weight loss > 3 kg within preceding 3 months to enrollment
- Use of bulk laxatives, fiber supplements or probiotic/prebiotic supplements
Sites / Locations
- University of Calgary
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Placebo Comparator
Experimental
Experimental
Experimental
Arm Label
Control
Protein
Fiber
Protein plus prebiotic fiber
Arm Description
Isocaloric food without the test protein and prebiotic fiber.
Dietary protein consumed as two daily servings of 5 grams protein/serving.
Prebiotic fiber consumed as two daily servings of 8 grams protein/serving.
Protein and prebiotic fiber consumed as two daily servings of 5 grams protein/serving plus 8 grams fiber/serving.
Outcomes
Primary Outcome Measures
Change in baseline fat mass at 12 weeks
Assessed with dual energy x-ray absorptiometry.
Secondary Outcome Measures
Change in baseline appetite at 12 weeks
Subjective appetite assessed with visual analog scales and objective appetite with a weighed lunch buffet.
Full Information
NCT ID
NCT02217579
First Posted
August 13, 2014
Last Updated
October 24, 2017
Sponsor
University of Calgary
Collaborators
General Mills
1. Study Identification
Unique Protocol Identification Number
NCT02217579
Brief Title
Effect of Protein and Prebiotic Fiber Intake on Adiposity in Overweight and Obese Adults
Official Title
Effect of Protein and Prebiotic Fiber Intake on Adiposity in Overweight and Obese Adults
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
August 2013 (Actual)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
August 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Calgary
Collaborators
General Mills
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The metabolic syndrome is rising worldwide as a consequence of the continued obesity epidemic. The current obesogenic environment makes the regulation of energy intake difficult and impedes the maintenance of weight loss. Dietary patterns and/or ingredients that curb hunger and reduce energy intake are critically needed. We hypothesize that inclusion of protein and prebiotic fiber in the diet will reduce adiposity in overweight and obesity adults.
Detailed Description
The main objective of our study is to assess the effects of protein and prebiotic fiber intake on changes in adiposity in an overweight and obese adult population.
Primary objective - To determine the effect of 12 week protein (10 g/day) or prebiotic fiber (16 g/day) intake on changes in body composition, chiefly body fat.
Secondary objective - To measure changes in appetite following 12 weeks of protein (10 g/day) or prebiotic fiber (16 g/day) intake.
Other outcomes includes changes in quality of life ratings and gut microbiota.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
Weight loss, Appetite, Overweight, Obesity, Dietary fiber, Dietary protein
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
132 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Isocaloric food without the test protein and prebiotic fiber.
Arm Title
Protein
Arm Type
Experimental
Arm Description
Dietary protein consumed as two daily servings of 5 grams protein/serving.
Arm Title
Fiber
Arm Type
Experimental
Arm Description
Prebiotic fiber consumed as two daily servings of 8 grams protein/serving.
Arm Title
Protein plus prebiotic fiber
Arm Type
Experimental
Arm Description
Protein and prebiotic fiber consumed as two daily servings of 5 grams protein/serving plus 8 grams fiber/serving.
Intervention Type
Dietary Supplement
Intervention Name(s)
Protein
Intervention Description
A food containing 5 grams/serving of supplemental protein.
Intervention Type
Dietary Supplement
Intervention Name(s)
Prebiotic fiber
Intervention Description
A food containing 8 grams/serving of supplemental prebiotic fiber.
Intervention Type
Dietary Supplement
Intervention Name(s)
Protein plus prebiotic fiber
Intervention Description
A food containing supplemental protein (5 grams/serving) and prebiotic fiber (8 grams/serving).
Intervention Type
Dietary Supplement
Intervention Name(s)
Control
Intervention Description
An isocaloric food not containing the test protein and fiber.
Primary Outcome Measure Information:
Title
Change in baseline fat mass at 12 weeks
Description
Assessed with dual energy x-ray absorptiometry.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Change in baseline appetite at 12 weeks
Description
Subjective appetite assessed with visual analog scales and objective appetite with a weighed lunch buffet.
Time Frame
12 weeks
Other Pre-specified Outcome Measures:
Title
Change in baseline quality of life rating at 12 weeks
Description
Measured with SF-36 questionnaire
Time Frame
12 weeks
Title
Change in baseline gut microbiota at 12 weeks
Description
Measured by high throughput sequencing
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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:
Type 1 diabetes
Clinically significant cardiovascular, liver or pancreas disease
Major gastrointestinal surgeries
Pregnant or lactating
Concomitant use of any weight loss medication, diet or exercise regime
Antibiotic use in the preceding 3 months to enrollment
Weight loss > 3 kg within preceding 3 months to enrollment
Use of bulk laxatives, fiber supplements or probiotic/prebiotic supplements
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raylene A Reimer, PhD, RD
Organizational Affiliation
University of Calgary
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Calgary
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 1N4
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
28730743
Citation
Reimer RA, Willis HJ, Tunnicliffe JM, Park H, Madsen KL, Soto-Vaca A. Inulin-type fructans and whey protein both modulate appetite but only fructans alter gut microbiota in adults with overweight/obesity: A randomized controlled trial. Mol Nutr Food Res. 2017 Nov;61(11). doi: 10.1002/mnfr.201700484. Epub 2017 Aug 29.
Results Reference
result
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Effect of Protein and Prebiotic Fiber Intake on Adiposity in Overweight and Obese Adults
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