NCT00522353

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started Jan 2007

Shorter than P25 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2007

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2007

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

August 27, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 29, 2007

Completed
Last Updated

May 23, 2008

Status Verified

May 1, 2008

Enrollment Period

4 months

First QC Date

August 27, 2007

Last Update Submit

May 21, 2008

Conditions

Keywords

obesityweight losssatiety hormonesbody compositionappetite ratings

Outcome Measures

Primary Outcomes (1)

  • Body weight

    3 months

Secondary Outcomes (1)

  • Plasma satiety hormones

    3 months

Study Arms (2)

1

ACTIVE COMPARATOR

Oligofructose

Dietary Supplement: Oligofructose

2

PLACEBO COMPARATOR

Placebo

Dietary Supplement: Placebo

Interventions

OligofructoseDIETARY_SUPPLEMENT

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

Also known as: Raftilose P95
1
PlaceboDIETARY_SUPPLEMENT

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

Also known as: Maltrin M100
2

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • overweight or class I obese individuals with BMI between 25 kg/m2 and 34.9 kg/m2
  • stable body weight in previous 3 months

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Calgary, Alberta, T2N 1N4, Canada

Location

Related Publications (2)

  • 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.

  • 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.

MeSH Terms

Conditions

ObesityWeight Loss

Interventions

oligofructosefructooligosaccharide

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight Changes

Study Officials

  • Raylene A. Reimer, PhD, RD

    University of Calgary

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 27, 2007

First Posted

August 29, 2007

Study Start

January 1, 2007

Primary Completion

May 1, 2007

Study Completion

August 1, 2007

Last Updated

May 23, 2008

Record last verified: 2008-05

Locations