Clinical trial NCT00912197: Effect of Oligofructose on Appetite in Overweight Subjects
Official title: Effect of Oligofructose on Appetite, Gut Hormones and Body Composition in Healthy Overweight Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Appetite Regulation
Obesity
Keywords: Appetite regulation
Oligofructose intake
Lead sponsor: Imperial College London
Sponsor class: OTHER
First posted: 2009-06-03
Enrollment: 28
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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.

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 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

Primary outcomes:
measure: Subjective Appetite Ratings in Hunger Compared to Baseline
timeFrame: Baseline, 56 days
measure: Subjective Appetite Ratings in Fullness Compared to Baseline
timeFrame: Baseline, 56 days
measure: Body Weight
timeFrame: Baseline, 56 days
measure: Energy Intake
timeFrame: Baseline, 56 days
measure: Gut Hormone PYY
timeFrame: baseline (Day 0) and post-supplementation (Day 56)
Secondary outcomes:
measure: Body Composition
timeFrame: Baseline, 56 days
measure: Imaging of Total Adipose Tissue
timeFrame: Baseline, 56 days
measure: Plasma Short-chain Fatty Acids Concentrations After Treatment
timeFrame: Baseline, 56 days
measure: Inflammatory Markers
timeFrame: baseline (Day 0) and post-supplementation (Day 56)
measure: Glycemic Response
timeFrame: baseline (Day 0) and post-supplementation (Day 56)
measure: Serum Insulin
timeFrame: baseline (Day 0) and post-supplementation (Day 56)
measure: Breath Hydrogen Levels
timeFrame: baseline (Day 0) and post-supplementation (Day 56)
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Imperial College London, Hammersmith Hospital
Study officials:
affiliation: Imperial College London
name: Gary S Frost
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pedersen C, Lefevre S, Peters V, Patterson M, Ghatei MA, Morgan LM, Frost GS. Gut hormone release and appetite regulation in healthy non-obese participants following oligofructose intake. A dose-escalation study. Appetite. 2013 Jul;66:44-53. doi: 10.1016/j.appet.2013.02.017. Epub 2013 Mar 5.
citation: Daud NM, Ismail NA, Thomas EL, Fitzpatrick JA, Bell JD, Swann JR, Costabile A, Childs CE, Pedersen C, Goldstone AP, Frost GS. The impact of oligofructose on stimulation of gut hormones, appetite regulation and adiposity. Obesity (Silver Spring). 2014 Jun;22(6):1430-8. doi: 10.1002/oby.20754. Epub 2014 Apr 8.