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Effect of Oligofructose on Appetite in Overweight Subjects

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ClinicalTrials.gov Identifier: NCT00912197
Recruitment Status : Completed
First Posted : June 3, 2009
Results First Posted : December 30, 2020
Last Update Posted : January 14, 2021
Sponsor:
Information provided by (Responsible Party):
Imperial College London

Tracking Information
First Submitted Date  ICMJE June 2, 2009
First Posted Date  ICMJE June 3, 2009
Results First Submitted Date  ICMJE October 24, 2019
Results First Posted Date  ICMJE December 30, 2020
Last Update Posted Date January 14, 2021
Actual Study Start Date  ICMJE June 2009
Actual Primary Completion Date August 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 13, 2021)
  • 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
  • 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
  • Body Weight [ Time Frame: Baseline, 56 days ]
  • 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).
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: June 2, 2009)
  • 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 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 13, 2021)
  • Body Composition [ Time Frame: Baseline, 56 days ]
    Body composition assessed by BMI
  • Imaging of Total Adipose Tissue [ Time Frame: Baseline, 56 days ]
    Total adipose tissue was assessed by FMRI at baseline and after treatment period
  • 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
  • Inflammatory Markers [ Time Frame: baseline (Day 0) and post-supplementation (Day 56) ]
    No data were collected for this Outcome Measure
  • 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).
  • Serum Insulin [ Time Frame: baseline (Day 0) and post-supplementation (Day 56) ]
    Plasma insulin concentrations were assayed using RIA kits (Millipore, MO).
  • Breath Hydrogen Levels [ Time Frame: baseline (Day 0) and post-supplementation (Day 56) ]
    breath hydrogen were obtained from volunteers throughout the study session.
Original Secondary Outcome Measures  ICMJE
 (submitted: June 2, 2009)
  • 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Oligofructose on Appetite in Overweight Subjects
Official Title  ICMJE Effect of Oligofructose on Appetite, Gut Hormones and Body Composition in Healthy Overweight Subjects
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Other
Condition  ICMJE
  • Appetite Regulation
  • Obesity
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: Oligofructose
    Participants received 10g of Oligofructose powdered supplements in sachets each containing 10 g dietary fiber) three times per day. Volunteers were instructed to take the supplement with their main meals.The 8-week supplementation period took place between visits 3 and 4 and included a 2-week run-in period to allow the bowel to adapt to the 30 g of dietary fiber.
    Intervention: Dietary Supplement: Oligofructose
  • Placebo Comparator: Cellulose and maltodextrin
    Participants received 10g of Cellulose powdered supplements in sachets each containing 10 g dietary fiber) three times per day. Volunteers were instructed to take the supplement with their main meals. Maltodextrin was added to the cellulose supplement. The 8-week supplementation period took place between visits 3 and 4 and included a 2-week run-in period to allow the bowel to adapt to the 30 g of dietary fiber.
    Intervention: Dietary Supplement: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 4, 2020)
28
Original Estimated Enrollment  ICMJE
 (submitted: June 2, 2009)
20
Actual Study Completion Date  ICMJE August 2011
Actual Primary Completion Date August 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00912197
Other Study ID Numbers  ICMJE CRO1243
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Imperial College London
Study Sponsor  ICMJE Imperial College London
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Gary S Frost Imperial College London
PRS Account Imperial College London
Verification Date January 2021

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