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Effect of Oligofructose on Appetite in Overweight Subjects

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00912197
First Posted: June 3, 2009
Last Update Posted: December 23, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Imperial College London
  Purpose
This study seeks to look into the effects of oligofructose supplementation on appetite, energy intake, and body weight and body composition in overweight subjects. Compared to a placebo product (cellulose) oligofructose is hypothesised to suppress hunger and thereby reduce food intake moderately leading to a decrease in body weight.

Condition Intervention
Appetite Regulation Obesity Dietary Supplement: Oligofructose Dietary Supplement: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Official Title: Effect of Oligofructose on Appetite, Gut Hormones and Body Composition in Healthy Overweight Subjects

Further study details as provided by Imperial College London:

Primary Outcome Measures:
  • Subjective appetite ratings [ Time Frame: Baseline and during and post-supplementation ]
  • Body weight [ Time Frame: Baseline and post-supplemention ]
  • Energy intake [ Time Frame: Before and during the supplementation ]
  • Appetite regulating hormones [ Time Frame: At baseline and at the end of the supplemention ]

Secondary Outcome Measures:
  • Body composition [ Time Frame: Assessments occur at baseline and post-supplementation ]
  • Imaging of appetite regulating centres (fMRI scans) [ Time Frame: At baseline and during supplementation ]
  • Plasma short-chain fatty acids concentrations [ Time Frame: At baseline and post-supplementation ]
  • Inflammatory markers [ Time Frame: Baseline and post-supplementation ]
  • Breath hydrogen levels [ Time Frame: Baseline and post-supplementation ]
  • Glycemic response [ Time Frame: baseline and post-supplementation ]
  • Serum insulin [ Time Frame: Baseline and post-supplementation ]

Enrollment: 22
Study Start Date: June 2009
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Oligofructose Dietary Supplement: Oligofructose
Participants will be asked to consume 30g of oligofructose daily for six weeks after a 2-week run-in.
Placebo Comparator: Cellulose and maltodextrin Dietary Supplement: Placebo
Participants will be asked to consume 3 doses (a total of 30g dietary fibres) of the placebo product daily for six weeks after a 2-week run-in

Detailed Description:

Appetite regulation plays an important part in energy balance. Suppressing appetite by manipulating the diet is a safe way of reducing energy intake and body weight compared to drug therapy and obesity surgery. How various nutrients affect appetite is not fully understood. Non-digestible carbohydrates (NDC) may affect appetite differently due to differences in physio-chemical properties.

This project will look into how two different NDC affect appetite and energy intake in overweight individuals in a randomised, double-blinded, placebo controlled parallel study. The NDC under investigation are oligofructose and cellulose, both natural compounds of plant origin. The former is broken down (fermented) in the large bowel by friendly bacteria producing various compounds that may affect appetite and the metabolism of the host.

Volunteers will consume one of the two NDC for eight weeks (including a two week run-in period). Appetite study session, functional MRI (fMRI) and MRI body fat scans will be conducted before and after the supplementation with NDC (or during the supplementation in the case of fMRI). Using fMRI the effect of the NDC supplementation on central appetite regulating centres will be investigated. Appetite questionnaires and dietary records will completed under free-living conditions at baseline and during the supplementation to explore the effect on subjective appetite feelings and energy intake, respectively.

It is hoped that this project will enhance the understanding of how NDC affect appetite and provide further information on how fermentation of NDC, gut hormone release, body composition, and appetite regulation are linked.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy males and females aged 20-50
  • BMI 25-35 kg/m2
  • Weight stable for three months prior to enrollment in study (weight change < 3 kg over a period of three months)
  • Habitual dietary fibre ≤ 25g/day (as assessed by 3-day dietary record)
  • Non-smokers
  • No current or history of endocrine disease, gastrointestinal disease, kidney or liver diseases, cardiovascular disease, pancreatitis, or cancer
  • Hydrogen producers

Exclusion Criteria:

  • Use of antibiotic less than three months prior to participation in the study
  • Participation in other research studies in the previous three months
  • Blood donation less than three months before participation in study
  • Anaemia
  • Hypertension
  • Pregnancy or breastfeeding
  • Substance abuse
  • Vegan diet
  • Regular use of prebiotic, probiotic or symbiotic food items/ supplements
  • Intense exercise undertaken for more than 5h per week
  • Metallic or electronic implants e.g. pacemaker, cochlear ear implants, fixed dental braces
  • Claustrophobia
  • Depression
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00912197


Locations
United Kingdom
Imperial College London, Hammersmith Hospital
London, United Kingdom, W12 0NN
Sponsors and Collaborators
Imperial College London
Investigators
Principal Investigator: Gary S Frost Imperial College London
  More Information

Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT00912197     History of Changes
Other Study ID Numbers: CRO1243
First Submitted: June 2, 2009
First Posted: June 3, 2009
Last Update Posted: December 23, 2011
Last Verified: December 2011

Additional relevant MeSH terms:
Overweight
Body Weight
Signs and Symptoms