ObesityNCT00750438
Effect of Fibre Products on Appetite and Weight
A study testing Propionate ester, Inulin and Cellulose in people with Obesity, run by Imperial College London at 1 site in United Kingdom.
Trial summary
This study explores the nutritional effects of fibre. Short chain fatty acid(SCFA), such as propionate, are produced through the fermentation of fibre in the bowel. SCFA are thought to have direct beneficial effects on the gut, appetite, weight and fat distribution. Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Propionate ester, Inulin and Cellulose
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2008to Oct 2012
- 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 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy male and female volunteers aged between 21 and 65 years
Who cannot join
- Weight change of more than 3kg in the preceding 2 months
- Current smokers
- Substance abuse
- Excess alcohol intake
- Pregnancy
- Diabetes
Show all 13Show fewer
- Cardiovascular disease
- Cancer
- Gastrointestinal disease e.g. inflammatory bowel disease or irritable bowel syndrome
- Kidney disease
- Liver disease
- Pancreatitis
- Use of medications including: anti inflammatory drugs or steroids, cholesterol lowering medication, androgens, phenytoin, erythromycin or thyroid hormones.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Increased Short Chain Fatty Acids in the Colon Are Associated With Improved Energy Homeostasis and Insulin Sensitivity.
This study explores the nutritional effects of fibre. Short chain fatty acid(SCFA), such as propionate, are produced through the fermentation of fibre in the bowel. SCFA are thought to have direct beneficial effects on the gut, appetite, weight and fat distribution. This study will look into these effects by conducting a dose finding study and then a randomised controlled study using healthy human volunteers.
Read the detailed description
This is a dose finding study in healthy overweight to obese human volunteers (BMI 25- 35) to find the level of oral supplementation with propionate that increases plasma propionate levels to 10x the current normal plasma level and use this dose of propionate in a randomised, placebo controlled double bind study. This study will compare propionate with fermentable and non fermentable carbohydrate. The outcome measures for this study will include assessments of appetite with feeding studies, measurement of insulin sensitivity using hyperinsulinaemic euglycaemic clamps and assessment of adipose tissue distribution using MRI scans and adipose tissue biopsy to determine changes in proliferation and differentiation of adipocytes.
- Conditions
- Obesity
- Being tested
- Propionate ester, Inulin, Cellulose
- Keywords
- Obesity, Short chain fatty acids, Appetite, Body weight, Insulin sensitivity, Propionate, Propionate ester
- Medical subject headings
- Obesity, Body Weight, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Propionate esterDietary supplement
The subject will take propionate ester at the dose specified by the dose finding study, three times a day for 24 weeks
InulinDietary supplement
The subjects in this group will take inulin at a comparable dose, three times a day for 24 weeks
CelluloseDietary supplement
The subjects in this group will take the non fermentable carbohydrate, cellulose, at a comparable dose for 24 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Propionate ester | Experimental | Not described Receives: Dietary Supplement: Propionate ester |
| Fermentable control | Placebo comparator | Not described Receives: Dietary Supplement: Inulin |
| Non fermentable control | Placebo comparator | Not described Receives: Dietary Supplement: Cellulose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Appetite_Food Intake
The change in food intake following 24 weeks of supplementation
Measured: Baseline, 24 weeks
Body Weight
Body weight was measured in all subjects to the nearest 0.1 kg (Tanita BC-418MA) while subjects were wearing light clothing.
Measured: Baseline, 24 weeks
Body Weight - Number of Participants Gained ≥3% of Their Baseline Body Weight
Body weight was measured in all subjects to the nearest 0.1 kg (Tanita BC-418MA) while subjects were wearing light clothing.
Measured: Baseline, 24 weeks
Secondary outcomes (2)
Adipose Tissue Distribution - Intra-abdominal Adipose Tissue
Body composition was assessed using MRI and MR spectroscopy (MRS), expressed as a percentage of total adipose tissue content.
Measured: 24 weeks
Insulin Sensitivity - HOMA IR
The homeostatic model assessment (HOMA) is a method used to quantify insulin resistance and beta-cell function.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2008 (estimated)
- Study startSep 2008
- Primary completionJul 2012
- Study completionOct 2012
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 ObesityStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gary Frost, PhD, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00750438
- Sponsor's protocol ID
- 08/H0707/99
- Status last verified
- Nov 2019
- First submitted
- 9 Sep 2008
- Last updated
- 19 Nov 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chambers ES, Viardot A, Psichas A, Morrison DJ, Murphy KG, Zac-Varghese SE, MacDougall K, Preston T, Tedford C, Finlayson GS, Blundell JE, Bell JD, Thomas EL, Mt-Isa S, Ashby D, Gibson GR, Kolida S, Dhillo WS, Bloom SR, Morley W, Clegg S, Frost G. Effects of targeted delivery of propionate to the human colon on appetite regulation, body weight maintenance and adiposity in overweight adults. Gut. 2015 Nov;64(11):1744-54. doi: 10.1136/gutjnl-2014-307913. Epub 2014 Dec 10.
PubMed 25500202Byrne CS, Chambers ES, Alhabeeb H, Chhina N, Morrison DJ, Preston T, Tedford C, Fitzpatrick J, Irani C, Busza A, Garcia-Perez I, Fountana S, Holmes E, Goldstone AP, Frost GS. Increased colonic propionate reduces anticipatory reward responses in the human striatum to high-energy foods. Am J Clin Nutr. 2016 Jul;104(1):5-14. doi: 10.3945/ajcn.115.126706. Epub 2016 May 11.
PubMed 27169834
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increased Short Chain Fatty Acids in the Colon Are Associated With Improved Energy Homeostasis and Insulin Sensitivity.
- ClinicalTrials.gov ID
- NCT00750438
- Acronym / sponsor ID
- 08/H0707/99
- Conditions
- Obesity
- Keywords
- Obesity, Short chain fatty acids, Appetite, Body weight, Insulin sensitivity, Propionate, Propionate ester
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- Sep 2008 (actual)
- Primary completion
- Jul 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 10 Sep 2008 (estimated)
- Results
- Posted 7 Nov 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study explores the nutritional effects of fibre. Short chain fatty acid(SCFA), such as propionate, are produced through the fermentation of fibre in the bowel. SCFA are thought to have direct beneficial effects on the gut, appetite, weight and fat distribution. This study will look into these effects by conducting a dose finding study and then a randomised controlled study using healthy human volunteers.
Detailed description
This is a dose finding study in healthy overweight to obese human volunteers (BMI 25- 35) to find the level of oral supplementation with propionate that increases plasma propionate levels to 10x the current normal plasma level and use this dose of propionate in a randomised, placebo controlled double bind study. This study will compare propionate with fermentable and non fermentable carbohydrate. The outcome measures for this study will include assessments of appetite with feeding studies, measurement of insulin sensitivity using hyperinsulinaemic euglycaemic clamps and assessment of adipose tissue distribution using MRI scans and adipose tissue biopsy to determine changes in proliferation and differentiation of adipocytes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Propionate ester | Experimental | Dietary Supplement: Propionate ester |
| Fermentable control | Placebo comparator | Dietary Supplement: Inulin |
| Non fermentable control | Placebo comparator | Dietary Supplement: Cellulose |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy male and female volunteers aged between 21 and 65 years
Key exclusion criteria (13 listed)
- Weight change of more than 3kg in the preceding 2 months
- Current smokers
- Substance abuse
- Excess alcohol intake
- Pregnancy
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 |
|---|---|---|
| Propionate esterThe subject will take propionate ester at the dose specified by the dose finding study, three times a day for 24 weeks | Dietary supplement | Propionate ester |
| InulinThe subjects in this group will take inulin at a comparable dose, three times a day for 24 weeks | Dietary supplement | Fermentable control |
| CelluloseThe subjects in this group will take the non fermentable carbohydrate, cellulose, at a comparable dose for 24 weeks. | Dietary supplement | Non fermentable control |
Primary outcome
Appetite_Food Intake
Time frame: Baseline, 24 weeks
The change in food intake following 24 weeks of supplementation
Body Weight
Time frame: Baseline, 24 weeks
Body weight was measured in all subjects to the nearest 0.1 kg (Tanita BC-418MA) while subjects were wearing light clothing.
Body Weight - Number of Participants Gained ≥3% of Their Baseline Body Weight
Time frame: Baseline, 24 weeks
Body weight was measured in all subjects to the nearest 0.1 kg (Tanita BC-418MA) while subjects were wearing light clothing.
2 secondary outcomes
Adipose Tissue Distribution - Intra-abdominal Adipose Tissue
Time frame: 24 weeks
Insulin Sensitivity - HOMA IR
Time frame: 24 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 25500202Chambers ES, Viardot A, Psichas A, Morrison DJ, Murphy KG, Zac-Varghese SE, MacDougall K, Preston T, Tedford C, Finlayson GS, Blundell JE, Bell JD, Thomas EL, Mt-Isa S, Ashby D, Gibson GR, Kolida S, Dhillo WS, Bloom SR, Morley W, Clegg S, Frost G. Effects of targeted delivery of propionate to the human colon on appetite regulation, body weight maintenance and adiposity in overweight adults. Gut. 2015 Nov;64(11):1744-54. doi: 10.1136/gutjnl-2014-307913. Epub 2014 Dec 10.
- Derived from this study: PubMed 27169834Byrne CS, Chambers ES, Alhabeeb H, Chhina N, Morrison DJ, Preston T, Tedford C, Fitzpatrick J, Irani C, Busza A, Garcia-Perez I, Fountana S, Holmes E, Goldstone AP, Frost GS. Increased colonic propionate reduces anticipatory reward responses in the human striatum to high-energy foods. Am J Clin Nutr. 2016 Jul;104(1):5-14. doi: 10.3945/ajcn.115.126706. Epub 2016 May 11.
- 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 Frost, PhD 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 Propionate ester, Inulin and Cellulose in people with 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 1 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 19 Nov 2019. 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 7 Nov 2019). 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?
Appetite_Food Intake (time frame: Baseline, 24 weeks). The study lists 3 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 NCT00750438, 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 19 Nov 2019.