Condition category
Nutritional, Metabolic, Endocrine
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status

Plain English Summary

Not provided at time of registration

Trial website

Contact information



Primary contact

Dr Edward Chambers


Contact details

Du Cane Road
W12 0NN
United Kingdom

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

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


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


Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type


Patient information sheet

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


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


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

Intervention type



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


Overall trial end date


Reason abandoned


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




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


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

Imperial College London
W12 0NN
United Kingdom

Sponsor information


Imperial College London (UK)

Sponsor details

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

Sponsor type




Funder type

Research council

Funder name

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

Alternative name(s)


Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit


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