Condition category
Nutritional, Metabolic, Endocrine
Date applied
Date assigned
Last edited
Prospectively registered
Overall trial status
Recruitment status
No longer recruiting
Publication status
Results overdue

Plain English Summary

Background and study aims
The hormone insulin is produced by β-cells in part of the pancreas known as the Islet of Langerhans. These β-cells can deteriorate and fail to release insulin due to age and lifestyle factors which can lead to the development of type 2 diabetes. Resistant starches are found within certain food products, particularly fruits, vegetables and whole grains, and are believed to be beneficial to β-cells. This is because the resistant starch is not digested and is instead used by bacteria within the gut. The bacteria ferment the resistant starch to produce short chain fatty acids (SCFAs), which are believed to improve β-cell function. We are investigating the effects of food products containing resistant starches found naturally in peas. The aim of this study is to see if resistant starch from peas can improve β-cell function.

Who can participate?
Patients aged between 18-65 with body mass index (BMI) of 20-35 kg/m2

What does the study involve?
Participants first meet one of the research doctors who interview them and conduct a general physical examination. Participants then undergo two separate 28-day dietary supplementation periods in a random order. In each supplementation period participants are provided with common food products (bread, soup, yoghurt, fruit juice, biscuit bars) supplemented with resistant starches or food products with no supplementation. Participants are asked to eat these food products in addition to their normal diet for 28 days. Before and at the end of each 28-day supplementation period participants attend two study visits on consecutive days at the Clinical Investigation Unit, Hammersmith Hospital to assess their β-cell function and insulin sensitivity. There is a break of 28 days between finishing the first dietary supplementation period and starting the second supplementation period.

What are the possible benefits and risks of participating?
Some of the procedures in this study, such as the recording of your weight, height and blood pressure, present no risk. Other procedures, such as taking blood samples, can cause mild discomfort. The risks of taking a blood sample include: slight discomfort when the needle is inserted and possible bruising and a localised infection. These procedures will only be carried out by experienced doctors under aseptic conditions to minimise all these risks. There are no major side effects associated with eating foods containing resistant starch; however, some people may experience mild abdominal bloating.

Where is the study run from?
Imperial College of Science, Technology and Medicine (UK)

When is the study starting and how long is it expected to run for?
April 2015 to April 2017

Who is funding the study?
Biotechnology and Biological Sciences Research Council (UK)

Who is the main contact?
Dr Edward Chambers

Trial website

Contact information



Primary contact

Dr Edward Chambers


Contact details

Imperial College of Science
Technology and Medicine
Du Cane Road
W12 0NN
United Kingdom

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

Dietary resistant starch from peas for healthy glucose homeostasis: a randomised controlled trial


Study hypothesis

The aim of this trial is to develop a systematic basis for increasing the intake of resistant starch in the diet in order to protect the function of insulin-secreting pancreatic beta-cells and improve blood glucose homeostasis in an ageing population.

Ethics approval

NRES Committee South East Coast – Surrey, 04/05/2015, ref: 15/LO/0184

Study design

Randomised; Interventional; Design type: Treatment

Primary study design


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet

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


Topic: Metabolic and endocrine disorders; Subtopic: Metabolic and Endocrine (all Subtopics); Disease: Metabolic & Endocrine (not diabetes)


Added 04/07/2016:
Our study will focus on peas, as there is a range of naturally occurring variants known to contain different types of resistant starch. Participants will be provided with normal peas (control) or peas with high resistant starch content (intervention) to add to their diets for 28 days.

Intervention type



Drug names

Primary outcome measure

Current primary outcome measures as of 04/07/2016:
Beta-cell function assessed by intravenous glucose tolerance test pre- and post 28 day intervention

Previous primary outcome measures:
Improvement in insulin sensitivity; Timepoint(s): 3 years

Secondary outcome measures

Added 04/07/2016:
1. Glucose and insulin responses assessed by meal tolerance test pre- and post 28 day intervention
2. Gastric emptying assessed by 13C ocatnoic breath test pre- and post 28 day intervention
3. Gut microbiota composition assessed from a stool sample pre- and post 28 day intervention

Overall trial start date


Overall trial end date


Reason abandoned (if study stopped)


Participant inclusion criteria

1. Body mass index (BMI) of 20-35 kg/m2
2. Age between 18-65 years (inclusive)

Participant type


Age group




Target number of participants

Planned Sample Size: 90; UK Sample Size: 90

Participant exclusion criteria

1. Weight change of = 3kg in the preceding 2 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 likely to interfere with energy metabolism, appetite regulation and hormonal balance, including: anti-inflammatory drugs or steroids, antibiotics, androgens, phenytoin, erythromycin or thyroid hormones.

Recruitment start date


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

Imperial College of Science, Technology and Medicine
Du Cane Road
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

Hospital/treatment centre



Funder type


Funder name

Biotechnology and Biological Sciences Research Council

Alternative name(s)


Funding Body Type

government organisation

Funding Body Subtype

National government


United Kingdom

Results and Publications

Publication and dissemination plan

The findings of the research will be published in an open-access, peer-reviewed journal. In addition we will be collaborating with patient groups and professional groups to disseminate the findings via multiple media channels such as patient association publications, print and broadcast media.

Intention to publish date

Participant level data

Not expected to be available

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

04/07/2016: Plain English summary added.