Effect of Oligofructose on Appetite in Overweight Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Imperial College London
ClinicalTrials.gov Identifier:
NCT00912197
First received: June 2, 2009
Last updated: December 22, 2011
Last verified: December 2011

June 2, 2009
December 22, 2011
June 2009
August 2011   (final data collection date for primary outcome measure)
  • Subjective appetite ratings [ Time Frame: Baseline and during and post-supplementation ] [ Designated as safety issue: No ]
  • Body weight [ Time Frame: Baseline and post-supplemention ] [ Designated as safety issue: No ]
  • Energy intake [ Time Frame: Before and during the supplementation ] [ Designated as safety issue: No ]
  • Appetite regulating hormones [ Time Frame: At baseline and at the end of the supplemention ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00912197 on ClinicalTrials.gov Archive Site
  • Body composition [ Time Frame: Assessments occur at baseline and post-supplementation ] [ Designated as safety issue: No ]
  • Imaging of appetite regulating centres (fMRI scans) [ Time Frame: At baseline and during supplementation ] [ Designated as safety issue: No ]
  • Plasma short-chain fatty acids concentrations [ Time Frame: At baseline and post-supplementation ] [ Designated as safety issue: No ]
  • Inflammatory markers [ Time Frame: Baseline and post-supplementation ] [ Designated as safety issue: No ]
  • Breath hydrogen levels [ Time Frame: Baseline and post-supplementation ] [ Designated as safety issue: No ]
  • Glycemic response [ Time Frame: baseline and post-supplementation ] [ Designated as safety issue: No ]
  • Serum insulin [ Time Frame: Baseline and post-supplementation ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Effect of Oligofructose on Appetite in Overweight Subjects
Effect of Oligofructose on Appetite, Gut Hormones and Body Composition in Healthy Overweight Subjects

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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
  • Appetite Regulation
  • Obesity
  • Dietary Supplement: Oligofructose
    Participants will be asked to consume 30g of oligofructose daily for six weeks after a 2-week run-in.
  • 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
  • Experimental: Oligofructose
    Intervention: Dietary Supplement: Oligofructose
  • Placebo Comparator: Cellulose and maltodextrin
    Intervention: Dietary Supplement: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
22
August 2011
August 2011   (final data collection date for primary outcome measure)

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
Both
20 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00912197
CRO1243
Yes
Imperial College London
Imperial College London
Not Provided
Principal Investigator: Gary S Frost Imperial College London
Imperial College London
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP