MedDataX Logo

Prebiotic Fiber as a Modifier of Satiety Hormones and Body Weight in Overweight and Obese Adults

NCT ID: NCT00522353

Last Updated: 2008-05-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Study Completion Date

2007-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to determine if oligofructose supplementation promotes weight loss in overweight and obese adults.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Obesity

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

obesity weight loss satiety hormones body composition appetite ratings

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

Oligofructose

Group Type ACTIVE_COMPARATOR

Oligofructose

Intervention Type DIETARY_SUPPLEMENT

21 grams per day in distributed over 3 doses per day for 3 months

2

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

7.89 grams of placebo maltodextrin divided into 3 equal doses per day for 3 months

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Oligofructose

21 grams per day in distributed over 3 doses per day for 3 months

Intervention Type DIETARY_SUPPLEMENT

Placebo

7.89 grams of placebo maltodextrin divided into 3 equal doses per day for 3 months

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Raftilose P95 Maltrin M100

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Calgary

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

University of Calgary

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Raylene A. Reimer, PhD, RD

Role: PRINCIPAL_INVESTIGATOR

University of Calgary

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Faculty of Kinesiology, Roger Jackson Centre for Health and Wellness Research

Calgary, Alberta, Canada

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Canada

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 28229548 (View on PubMed)

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.

Reference Type DERIVED
PMID: 19386741 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

UC 20085

Identifier Type: -

Identifier Source: org_study_id