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Effect of Oligofructose on Appetite in Overweight Subjects

Primary Purpose

Appetite Regulation, Obesity

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Oligofructose
Placebo
Sponsored by
Imperial College London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Appetite Regulation focused on measuring Appetite regulation, Oligofructose intake

Eligibility Criteria

20 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Imperial College London, Hammersmith Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Oligofructose

Cellulose and maltodextrin

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Subjective Appetite Ratings in Hunger Compared to Baseline
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
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
Energy Intake
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
Total PYY concentrations were quantified using specific and sensitive in-house radio-immunoassays as previously described.

Secondary Outcome Measures

Body Composition
Body composition assessed by BMI
Imaging of Total Adipose Tissue
Total adipose tissue was assessed by FMRI at baseline and after treatment period
Plasma Short-chain Fatty Acids Concentrations After Treatment
Short-chain fatty acids (acetate, propionate, butyrate) concentrations assessed from plasma at 56 days at 450min timepoint with gas chromatography
Inflammatory Markers
No data were collected for this Outcome Measure
Glycemic Response
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
Plasma insulin concentrations were assayed using RIA kits (Millipore, MO).
Breath Hydrogen Levels
breath hydrogen were obtained from volunteers throughout the study session.

Full Information

First Posted
June 2, 2009
Last Updated
January 13, 2021
Sponsor
Imperial College London
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1. Study Identification

Unique Protocol Identification Number
NCT00912197
Brief Title
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

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
June 2009 (Actual)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
August 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Imperial College London

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Appetite Regulation, Obesity
Keywords
Appetite regulation, Oligofructose intake

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Oligofructose
Arm Type
Experimental
Arm Description
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.
Arm Title
Cellulose and maltodextrin
Arm Type
Placebo Comparator
Arm Description
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 Type
Dietary Supplement
Intervention Name(s)
Oligofructose
Intervention Description
Participants will be asked to consume 30g of oligofructose daily for six weeks after a 2-week run-in.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
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 Measure Information:
Title
Subjective Appetite Ratings in Hunger Compared to Baseline
Description
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
Time Frame
Baseline, 56 days
Title
Subjective Appetite Ratings in Fullness Compared to Baseline
Description
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
Time Frame
Baseline, 56 days
Title
Body Weight
Time Frame
Baseline, 56 days
Title
Energy Intake
Description
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).
Time Frame
Baseline, 56 days
Title
Gut Hormone PYY
Description
Total PYY concentrations were quantified using specific and sensitive in-house radio-immunoassays as previously described.
Time Frame
baseline (Day 0) and post-supplementation (Day 56)
Secondary Outcome Measure Information:
Title
Body Composition
Description
Body composition assessed by BMI
Time Frame
Baseline, 56 days
Title
Imaging of Total Adipose Tissue
Description
Total adipose tissue was assessed by FMRI at baseline and after treatment period
Time Frame
Baseline, 56 days
Title
Plasma Short-chain Fatty Acids Concentrations After Treatment
Description
Short-chain fatty acids (acetate, propionate, butyrate) concentrations assessed from plasma at 56 days at 450min timepoint with gas chromatography
Time Frame
Baseline, 56 days
Title
Inflammatory Markers
Description
No data were collected for this Outcome Measure
Time Frame
baseline (Day 0) and post-supplementation (Day 56)
Title
Glycemic Response
Description
Glucose was analyzed in the Department of Clinical Biochemistry, Hammer-smith Hospital, London using an Abbott Architect ci8200 analyzer(Abbott Diagnostics, Maidenhead, UK).
Time Frame
baseline (Day 0) and post-supplementation (Day 56)
Title
Serum Insulin
Description
Plasma insulin concentrations were assayed using RIA kits (Millipore, MO).
Time Frame
baseline (Day 0) and post-supplementation (Day 56)
Title
Breath Hydrogen Levels
Description
breath hydrogen were obtained from volunteers throughout the study session.
Time Frame
baseline (Day 0) and post-supplementation (Day 56)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gary S Frost
Organizational Affiliation
Imperial College London
Official's Role
Principal Investigator
Facility Information:
Facility Name
Imperial College London, Hammersmith Hospital
City
London
ZIP/Postal Code
W12 0NN
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
23474087
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.
Results Reference
result
PubMed Identifier
24715424
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.
Results Reference
result

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Effect of Oligofructose on Appetite in Overweight Subjects

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