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Effect of Oligofructose on Appetite in Overweight Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

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.

Condition or disease Intervention/treatment Phase
Appetite Regulation Obesity Dietary Supplement: Oligofructose Dietary Supplement: Placebo Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Other
Official Title: Effect of Oligofructose on Appetite, Gut Hormones and Body Composition in Healthy Overweight Subjects
Actual Study Start Date : June 2009
Actual Primary Completion Date : August 2011
Actual Study Completion Date : August 2011

Arm Intervention/treatment
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.
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
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.
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




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00912197


Locations
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United Kingdom
Imperial College London, Hammersmith Hospital
London, United Kingdom, W12 0NN
Sponsors and Collaborators
Imperial College London
Investigators
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Principal Investigator: Gary S Frost Imperial College London
Publications of Results:
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Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT00912197    
Other Study ID Numbers: CRO1243
First Posted: June 3, 2009    Key Record Dates
Results First Posted: December 30, 2020
Last Update Posted: January 14, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Imperial College London:
Appetite regulation
Oligofructose intake
Additional relevant MeSH terms:
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Overweight
Body Weight