Back to resultsPrebiotic Fiber as a Modifier of Satiety Hormones and Body Weight in Overweight and Obese Adults
Primary Purpose
Obesity
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Oligofructose
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Obesity focused on measuring obesity, weight loss, satiety hormones, body composition, appetite ratings
Eligibility Criteria
Inclusion Criteria:
- overweight or class I obese individuals with BMI between 25 kg/m2 and 34.9 kg/m2
- stable body weight in previous 3 months
Exclusion Criteria:
- Type 1 and Type 2 diabetes
- clinically significant cardiovascular abnormalities
- liver or pancreas disease
- major gastrointestinal surgeries
- are pregnant or lactating
- exhibit alcohol or drug dependence
- on drugs influencing appetite
- are following a diet or exercise regime designed for weight loss
- have a body mass greater than 350lb
- chronic use of antacids or bulk laxatives
Sites / Locations
- Faculty of Kinesiology, Roger Jackson Centre for Health and Wellness Research
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
1
2
Arm Description
Oligofructose
Placebo
Outcomes
Primary Outcome Measures
Body weight
Secondary Outcome Measures
Plasma satiety hormones
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00522353
Brief Title
Prebiotic Fiber as a Modifier of Satiety Hormones and Body Weight in Overweight and Obese Adults
Official Title
Effect of Oligofructose Versus Placebo on Body Weight and Satiety Hormone Secretion in Overweight and Obese Adults.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2008
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
May 2007 (Actual)
Study Completion Date
August 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Calgary
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to determine if oligofructose supplementation promotes weight loss in overweight and obese adults.
Detailed Description
Obesity is a primary health concern for many western countries as it is linked to several chronic diseases as well as, large health care costs. Although obesity is a multifactorial disease, it is known that levels of satiety hormones including glucagon like peptide-1 (GLP-1) and peptide YY (PYY) are reduced in obesity. The ability of prebiotic fiber to promote weight loss through the production of satiety hormones has been tested previously using rodents. Here it was found that prebiotic supplementation resulted in a decreased energy intake, higher GLP-1 levels in the plasma and increased proglucagon mRNA levels in the gut. This study will address the important question of whether prebiotic fiber supplementation is effective in reducing body weight in overweight or obese human subjects.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
obesity, weight loss, satiety hormones, body composition, appetite ratings
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
Oligofructose
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Dietary Supplement
Intervention Name(s)
Oligofructose
Other Intervention Name(s)
Raftilose P95
Intervention Description
21 grams per day in distributed over 3 doses per day for 3 months
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Other Intervention Name(s)
Maltrin M100
Intervention Description
7.89 grams of placebo maltodextrin divided into 3 equal doses per day for 3 months
Primary Outcome Measure Information:
Title
Body weight
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Plasma satiety hormones
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
overweight or class I obese individuals with BMI between 25 kg/m2 and 34.9 kg/m2
stable body weight in previous 3 months
Exclusion Criteria:
Type 1 and Type 2 diabetes
clinically significant cardiovascular abnormalities
liver or pancreas disease
major gastrointestinal surgeries
are pregnant or lactating
exhibit alcohol or drug dependence
on drugs influencing appetite
are following a diet or exercise regime designed for weight loss
have a body mass greater than 350lb
chronic use of antacids or bulk laxatives
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
Faculty of Kinesiology, Roger Jackson Centre for Health and Wellness Research
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 1N4
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
28229548
Citation
Parnell JA, Klancic T, Reimer RA. Oligofructose decreases serum lipopolysaccharide and plasminogen activator inhibitor-1 in adults with overweight/obesity. Obesity (Silver Spring). 2017 Mar;25(3):510-513. doi: 10.1002/oby.21763.
Results Reference
derived
PubMed Identifier
19386741
Citation
Parnell JA, Reimer RA. Weight loss during oligofructose supplementation is associated with decreased ghrelin and increased peptide YY in overweight and obese adults. Am J Clin Nutr. 2009 Jun;89(6):1751-9. doi: 10.3945/ajcn.2009.27465. Epub 2009 Apr 22.
Results Reference
derived
Learn more about this trial
Prebiotic Fiber as a Modifier of Satiety Hormones and Body Weight in Overweight and Obese Adults
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