Appetite RegulationNCT00912197
Effect of Oligofructose on Appetite in Overweight Subjects
A study testing Oligofructose in people with Appetite Regulation and Obesity, run by Imperial College London at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Appetite Regulation, Obesity
- What is being tested?
- Oligofructose
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2009to Aug 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Imperial College London, Hammersmith Hospital
London, W12 0NN
About this study
Official title: Effect of Oligofructose on Appetite, Gut Hormones and Body Composition in Healthy 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.
Read the 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.
- Conditions
- Appetite Regulation, Obesity
- Being tested
- Oligofructose, Placebo
- Keywords
- Appetite regulation, Oligofructose intake
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OligofructoseDietary supplement
Participants will be asked to consume 30g of oligofructose daily for six weeks after a 2-week run-in.
PlaceboDietary 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
| Study group | Role | What they receive |
|---|---|---|
| Oligofructose | Experimental | 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. Receives: Dietary Supplement: Oligofructose |
| Cellulose and maltodextrin | Placebo comparator | 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. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline, 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
Measured: Baseline, 56 days
Body Weight
Measured: Baseline, 56 days
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).
Measured: Baseline, 56 days
Gut Hormone PYY
Total PYY concentrations were quantified using specific and sensitive in-house radio-immunoassays as previously described.
Measured: baseline (Day 0) and post-supplementation (Day 56)
Secondary outcomes (7)
Body Composition
Body composition assessed by BMI
Measured: Baseline, 56 days
Imaging of Total Adipose Tissue
Total adipose tissue was assessed by FMRI at baseline and after treatment period
Measured: Baseline, 56 days
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
Measured: Baseline, 56 days
Inflammatory Markers
No data were collected for this Outcome Measure
Measured: baseline (Day 0) and post-supplementation (Day 56)
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).
Measured: baseline (Day 0) and post-supplementation (Day 56)
Serum Insulin
Plasma insulin concentrations were assayed using RIA kits (Millipore, MO).
Measured: baseline (Day 0) and post-supplementation (Day 56)
Breath Hydrogen Levels
breath hydrogen were obtained from volunteers throughout the study session.
Measured: baseline (Day 0) and post-supplementation (Day 56)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2009 (estimated)
- Study startJun 2009
- Primary completionAug 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Appetite RegulationStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gary S Frost, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00912197
- Sponsor's protocol ID
- CRO1243
- Status last verified
- Jan 2021
- First submitted
- 2 Jun 2009
- Last updated
- 14 Jan 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 23474087Daud 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.
PubMed 24715424
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Oligofructose on Appetite, Gut Hormones and Body Composition in Healthy Overweight Subjects
- ClinicalTrials.gov ID
- NCT00912197
- Acronym / sponsor ID
- CRO1243
- Conditions
- Appetite Regulation, Obesity
- Keywords
- Appetite regulation, Oligofructose intake
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- Jun 2009 (actual)
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 3 Jun 2009 (estimated)
- Results
- Posted 30 Dec 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oligofructose | Experimental | Dietary Supplement: OligofructoseParticipants 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. |
| Cellulose and maltodextrin | Placebo comparator | Dietary Supplement: PlaceboParticipants 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. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OligofructoseParticipants will be asked to consume 30g of oligofructose daily for six weeks after a 2-week run-in. | Dietary supplement | Oligofructose |
| PlaceboParticipants 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 | Dietary supplement | Cellulose and maltodextrin |
Primary outcome
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.
7 secondary outcomes
Body Composition
Time frame: Baseline, 56 days
Imaging of Total Adipose Tissue
Time frame: Baseline, 56 days
Plasma Short-chain Fatty Acids Concentrations After Treatment
Time frame: Baseline, 56 days
Inflammatory Markers
Time frame: baseline (Day 0) and post-supplementation (Day 56)
Glycemic Response
Time frame: baseline (Day 0) and post-supplementation (Day 56)
Serum Insulin
Time frame: baseline (Day 0) and post-supplementation (Day 56)
Breath Hydrogen Levels
Time frame: baseline (Day 0) and post-supplementation (Day 56)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 23474087Pedersen 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 publication: PubMed 24715424Daud 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gary S Frost principal investigator
Imperial College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oligofructose in people with Appetite Regulation and Obesity, run by Imperial College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Dec 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subjective Appetite Ratings in Hunger Compared to Baseline (time frame: Baseline, 56 days). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00912197, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2021.