Condition category
Nutritional, Metabolic, Endocrine
Date applied
26/09/2014
Date assigned
26/09/2014
Last edited
09/06/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Edward Chambers

ORCID ID

Contact details

Du Cane Road
London
W12 0NN
United Kingdom
-
e.chambers@imperial.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

16734

Study information

Scientific title

Effect of increased propionate in the colon on appetite and glucose homeostasis

Acronym

Study hypothesis

Increased intake of dietary fibre has been associated with reduced appetite and weight loss. In particular, evidence suggests that the fermentable component of dietary fibre is critical in mediating these satiating effects. The short chain fatty acids (SCFAs) produced by microbial fermentation of dietary fibre in the colon have been shown to stimulate the release of appetite suppressing hormones peptide YY (PYY) and glucagon like peptide-1 (GLP-1). Increasing colonic SCFA levels is therefore an attractive target for appetite modulation. To overcome the unpalatably high levels of fermentable dietary fibre needed to significantly increase colonic SCFA levels, we have developed a novel delivery system targeting the release of gram quantities of the SCFA propionate in the human colon. A propionate ester has been produced whereby propionate is chemically bound by an ester bond to inulin, a natural dietary fibre composed mainly of fructose. The majority of propionate bound to inulin should only be released when the inulin polymer is fermented by the colonic microbiota, thus providing targeted colonic delivery. Our previous studies (Effect of Fibre Products on Appetite and Weight; REC Reference: 08/H0707/99) have found that acute ingestion of propionate ester increases plasma PYY and GLP-1 concentrations and reduces food intake. Furthermore, long-term (24 weeks) ingestion of propionate ester significantly reduced body weight gain and the development of abdominal adipose tissue, major risk factors in the development of insulin resistance and diabetes. The current protocol comprises two follow-on studies which have the following aims:

1. Confirm the appetite suppressing effects of propionate ester when incorporated into a food product.
2. Assess the effects of propionate ester on glucose and lipid metabolism.

Ethics approval

14/LO/0645; First MREC approval date 19/05/2014

Study design

Randomised; Interventional; Design type: Not specified

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Topic: Primary Care, Metabolic and endocrine disorders; Subtopic: Metabolic and Endocrine (all Subtopics), Metabolic and endocrine disorders; Disease: Metabolic & Endocrine (not diabetes), All Diseases

Intervention

Cellulose, Control; Inulin, Control; Inulin-propionate ester, Inulin-propionate ester; Study Entry : Single Randomisation only

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Glucose homeostasis; Timepoint(s): End of each 6 week intervention

Secondary outcome measures

Body composition; Timepoint(s): End of each 6 week intervention

Overall trial start date

13/08/2014

Overall trial end date

01/07/2017

Reason abandoned

Eligibility

Participant inclusion criteria

1. Healthy volunteers aged 18-65
2. Male or female
3. Body mass index (weight in kg divided by height in metre squared) of 25-40 kg/m2

Participant type

Healthy volunteer

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 40; UK Sample Size: 40

Participant exclusion criteria

Study 1 and Study 2:
1. Weight change of more than 3kg in the preceding 3 months
2. Current smokers
3. Substance abuse
4. Excess alcohol intake
5. Pregnancy
6. Diabetes
7. Cardiovascular disease
8. Cancer
9. Gastrointestinal disease e.g. inflammatory bowel disease or irritable bowel syndrome
10. Kidney disease
11. Liver disease
12. Pancreatitis
13. Use of medications including: antiinflammatory drugs or steroids, androgens, phenytoin, erythromycin or thyroid hormones

Study 2 has the additional exclusion criteria:
14.• Metallic or magnetic implants such as pacemakers
•15. Claustrophobia

Recruitment start date

13/08/2014

Recruitment end date

01/07/2017

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Imperial College London
London
W12 0NN
United Kingdom

Sponsor information

Organisation

Imperial College London (UK)

Sponsor details

Joint Research Compliance Office
Charing Cross Hospital
Fulham Palace Road
London
W6 8RF
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Research council

Funder name

Biotechnology and Biological Sciences Research Council (BBSRC); Grant Codes: BB/L004259/1

Alternative name(s)

BBSRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes