Condition category
Nutritional, Metabolic, Endocrine
Date applied
04/07/2014
Date assigned
04/07/2014
Last edited
11/07/2014
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
High fibre diets are known to be related to a number of health benefits and have been widely advertised (in breakfast cereals, for example) as a way of helping people to lose weight. We are currently researching short chain fatty acids, one of the breakdown products of fibre, which may be responsible for the beneficial effects of fibre. Our recent work suggests that one specific short chain fatty acid, propionate, is associated with a reduction in feelings of hunger. Different dietary fibres produce different amounts of propionate. It is currently unknown which dietary fibres produce the largest amounts of propionate and whether they affect appetite (i.e. how hungry or full you feel). The aim of this study is to find out the effects of a range of dietary fibres on propionate levels and appetite. This may be important in terms of controlling body weight and therefore preventing obesity.

Who can participate?
This study will be carried out in healthy men and women, aged 18-65 years old, who are either normal weight or overweight.

What does the study involve?
There are two parts to this study. Part A and B both consist of four separate study visits. In Part A, on the study days participants will receive a standard breakfast containing 10g of one of four food supplements and two non-radioactive tracer molecules, which will be used in order to track the digestive process. A standard snack and meal will also be provided. Participants will complete questionnaires to measure appetite, and breath and blood samples will be collected. In Part B, participants will be instructed to consume one of the four dietary supplements from Part A in an increased dose for 7 days before each of the four study visits. On study days, participants will consume a standard breakfast, which will contain 10 g of the same dietary supplement that they have been taking. A snack and buffet meal will also be provided. The following measurements will be collected: amount of propionate in blood, appetite ratings using questionnaires, food intake at a buffet meal (where participants are instructed to eat until they feel comfortably full) and breath hydrogen samples.

What are the possible benefits and risks of participating?
Volunteers will not benefit directly from this study but the results may help doctors in the future treat patients with obesity. Some of the procedures in this study, such as the recording of your weight, height and blood pressure, and the collection of breath samples, present no risk. Taking blood samples can cause mild discomfort when the needle is inserted, and possible bruising and infection in that area. These procedures will only be carried out by experienced healthcare professionals under germ-free conditions in order to minimise such risks. As with any high fibre diet, volunteers may experience tummy bloating and discomfort. There is also a small chance that volunteers may experience episodes of diarrhoea during the study. In order to minimise the risk of this happening, in Part B the total dose of dietary supplement being consumed will be increased slowly over the course of the 7 days before each study visit. Volunteers may also find the taste of the dietary supplements unpleasant and so will be advised on the best way to add it into your diet. The addition of the dietary supplement to their daily routine will be an inconvenience and will require a change in lifestyle. To minimise inconvenience, all supplements will be provided in ready-to-use sachets.

Where is the study run from?
Hammersmith Hospital (UK).

When is the study starting and how long is it expected to run for?
The study will start in August 2014 and will run until July 2015.

Who is funding the study?
Medical Research Council (MRC) (UK).

Who is the main contact?
Miss Claire Byrne
Claire.byrne@imperial.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Miss Claire Byrne

ORCID ID

Contact details

Du Cane Road
London
W12 0NN
United Kingdom
Claire.byrne@imperial.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

16769

Study information

Scientific title

The effect of short-term dietary supplementation of fermentable carbohydrates on propionate production and appetite measures: a pilot study

Acronym

Study hypothesis

The aim of this study is to investigate whether short-term dietary supplementation of fermentable carbohydrate (FC) increases plasma propionate concentrations and suppresses appetite in humans.

Ethics approval

NRES Committee London – Harrow, 16/06/2014, ref. 14/LO/0704

Study design

Randomised single-blind cross-over feeding study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Topic: Primary Care; Subtopic: Not Assigned; Disease: All Diseases

Intervention

This will be a study comparing the effects of B-glucan (fermentable, soluble and viscous) on appetite and plasma propionate concentrations, with inulin (fermentable, soluble and non-viscous), cellulose (non-fermentable, insoluble and non-viscous) and methyl cellulose (non-fermentable, soluble and viscous). This study will involve four separate 7-day feeding periods followed by study days, with a 2-week wash-out period between study visits. This study will be preceded by a protocol optimisation study, which will involve four separate study visits. Inulin will be used as a positive control (as we know it is fermented in the colon) and cellulose as a negative control (as we know it does not ferment significantly in the colon) in both studies. The addition of methyl cellulose (a non-fermentable, soluble and viscous product) as a fourth leg to both studies will allow for the assessment of the effect of viscosity on appetite measures. Two studies are proposed: an optimisation study to assess the effect of FCs on gut transit time and therefore optimise sampling regimens, and a feeding study to assess the effect of FCs on appetite.

In the Optimisation Study, participants will consume 10 g of one of the four dietary supplements on each of the four study days according to their randomisation pattern.

In the Feeding Study, participants will consume a different dietary supplement in a stepped dose for 7 days prior to each one of the four study visits. Participants will consume 10 g of the appropriate dietary supplement on day 1, two 10 g servings on days 2-3 (total daily dose 20 g), and three 10 g servings on days 4-7 (total daily dose 30 g). On study days, volunteers will receive 10 g of the appropriate dietary supplement with their breakfast. The maximum dose used in this study is based on previous work carried out by our research group.

Randomisation will be conducted by sealed envelopes once the participants have successfully passed the health screening. The participants will be blinded as to the type of supplement they are taking.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Appetite; Timepoint(s): measures every 30 minutes over the study period

Secondary outcome measures

1. 13CO2 enriched breath hydrogen; Timepoint(s): measure every 30 minutes over the time period
2. Plasma propionate; Timepoint(s): measured every 30 minutes over the study period

Overall trial start date

01/08/2014

Overall trial end date

31/07/2015

Reason abandoned

Eligibility

Participant inclusion criteria

1. Body Mass Index (BMI) 20-35 kg/m2
2. Age 18-65

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 20; UK Sample Size: 20

Participant exclusion criteria

Any gastrointestinal disease

Recruitment start date

01/08/2014

Recruitment end date

31/07/2015

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Du Cane Road
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

Medical Research Council (MRC) (UK) - Clinical Trials Unit (CTU)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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