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
  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 Blind (Subject)
Official Title: Effect of Oligofructose on Appetite, Gut Hormones and Body Composition in Healthy Overweight Subjects

Resource links provided by NLM:


Further study details as provided by Imperial College London:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

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

Ages Eligible for Study:   20 Years to 50 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT00912197     History of Changes
Other Study ID Numbers: CRO1243
Study First Received: June 2, 2009
Last Updated: December 22, 2011
Health Authority: United Kingdom: Research Ethics Committee

Additional relevant MeSH terms:
Obesity
Overweight
Overnutrition
Nutrition Disorders
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on April 16, 2014