Effect of Fibre Products on Appetite and Weight

NCT ID: NCT00750438

Last Updated: 2019-11-19

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2012-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Obesity

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Propionate ester

Group Type EXPERIMENTAL

Propionate ester

Intervention Type DIETARY_SUPPLEMENT

The subject will take propionate ester at the dose specified by the dose finding study, three times a day for 24 weeks

Fermentable control

Group Type PLACEBO_COMPARATOR

Inulin

Intervention Type DIETARY_SUPPLEMENT

The subjects in this group will take inulin at a comparable dose, three times a day for 24 weeks

Non fermentable control

Group Type PLACEBO_COMPARATOR

Cellulose

Intervention Type DIETARY_SUPPLEMENT

The subjects in this group will take the non fermentable carbohydrate, cellulose, at a comparable dose for 24 weeks.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Propionate ester

The subject will take propionate ester at the dose specified by the dose finding study, three times a day for 24 weeks

Intervention Type DIETARY_SUPPLEMENT

Inulin

The subjects in this group will take inulin at a comparable dose, three times a day for 24 weeks

Intervention Type DIETARY_SUPPLEMENT

Cellulose

The subjects in this group will take the non fermentable carbohydrate, cellulose, at a comparable dose for 24 weeks.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Healthy male and female volunteers aged between 21 and 65 years

Exclusion Criteria

* Weight change of more than 3kg in the preceding 2 months
* Current smokers
* Substance abuse
* Excess alcohol intake
* Pregnancy
* Diabetes
* 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.
Minimum Eligible Age

21 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Imperial College London

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Gary Frost, PhD

Role: PRINCIPAL_INVESTIGATOR

Imperial College London

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Hammersmith Hospital

London, UK, United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United Kingdom

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type RESULT
PMID: 25500202 (View on PubMed)

Byrne 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.

Reference Type DERIVED
PMID: 27169834 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

08/H0707/99

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Fiber Fermentation Study
NCT04570137 COMPLETED NA
The Fibre Full Study
NCT06416254 RECRUITING NA
Flaxseed Mucilage and Satiety
NCT01238744 UNKNOWN NA