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Completed

NCT Number: NCT00912197

Effect of Oligofructose on Appetite in 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.

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Key information

Age range

20 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Imperial College London, Hammersmith Hospital

London, W12 0NN, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oligofructose

Dietary Supplement

Participants will be asked to consume 30g of oligofructose daily for six weeks after a 2-week run-in.

Placebo

Dietary Supplement

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

Primary outcomes

  1. Subjective Appetite Ratings in Hunger Compared to Baseline

    Time frame: Baseline, 56 days

    Hunger was assessed by visual analogue scales (Each scale is 10cm in length with words anchored at each end, expressing the most positive (Minimum score = 0 cm and means no hunger) and the most negative rating (Maximum score = 10 cm and means very hungry). Compared to baseline after treatment at 56 days

  2. Subjective Appetite Ratings in Fullness Compared to Baseline

    Time frame: Baseline, 56 days

    Fullness are assessed by visual analogue scale, 10 cm in length with words anchored at each end, expressing the most positive (feel full: maximum Score=10cm) and the most negative rating (feeling empty: Minimum Score = 0cm), values at baseline and after treatments at 56 days

  3. Body Weight

    Time frame: Baseline, 56 days

  4. Energy Intake

    Time frame: Baseline, 56 days

    Energy intake was assessed by 7-days food diary at baseline and last week of treatment, diaries were analysed by Dietplan6 software.

    The values in the table represent the Energy intake as measured over the whole week (as opposed to reporting the Energy intake per day based on the 7 day data).

  5. Gut Hormone PYY

    Time frame: baseline (Day 0) and post-supplementation (Day 56)

    Total PYY concentrations were quantified using specific and sensitive in-house radio-immunoassays as previously described.

Secondary outcomes

  1. Body Composition

    Time frame: Baseline, 56 days

    Body composition assessed by BMI

  2. Imaging of Total Adipose Tissue

    Time frame: Baseline, 56 days

    Total adipose tissue was assessed by FMRI at baseline and after treatment period

  3. Plasma Short-chain Fatty Acids Concentrations After Treatment

    Time frame: Baseline, 56 days

    Short-chain fatty acids (acetate, propionate, butyrate) concentrations assessed from plasma at 56 days at 450min timepoint with gas chromatography

  4. Inflammatory Markers

    Time frame: baseline (Day 0) and post-supplementation (Day 56)

    No data were collected for this Outcome Measure

  5. Glycemic Response

    Time frame: baseline (Day 0) and post-supplementation (Day 56)

    Glucose was analyzed in the Department of Clinical Biochemistry, Hammer-smith Hospital, London using an Abbott Architect ci8200 analyzer(Abbott Diagnostics, Maidenhead, UK).

  6. Serum Insulin

    Time frame: baseline (Day 0) and post-supplementation (Day 56)

    Plasma insulin concentrations were assayed using RIA kits (Millipore, MO).

  7. Breath Hydrogen Levels

    Time frame: baseline (Day 0) and post-supplementation (Day 56)

    breath hydrogen were obtained from volunteers throughout the study session.

Sponsors and collaborators

Lead sponsor

Imperial College London

Other

Registry information

Official study title

Effect of Oligofructose on Appetite, Gut Hormones and Body Composition in Healthy Overweight Subjects

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Jun 3, 2009
Registry last updated
Jan 14, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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