Dietary resistant starch from peas for healthy glucose homeostasis

ISRCTN ISRCTN13747085
DOI https://doi.org/10.1186/ISRCTN13747085
IRAS number 168400
Secondary identifying numbers CPMS 18551, IRAS 168400
Submission date
11/03/2015
Registration date
12/03/2015
Last edited
22/03/2024
Recruitment status
Recruiting
Overall study status
Ongoing
Condition category
Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

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 18-65 years 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 September 2026

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

Who is the main contact?
Dr Katerina Petropoulou, katerina.petropoulou12@imperial.ac.uk

Contact information

Dr Katerina Petropoulou
Scientific

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

Phone +44 (0) 7428732523
Email katerina.petropoulou12@imperial.ac.uk

Study information

Study designRandomized; Interventional; Design type: Treatment
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typeTreatment
Participant information sheet Not available in web format, please use contact details to request a patient information sheet
Scientific titleDietary resistant starch from peas for healthy glucose homeostasis: a randomised controlled trial
Study acronymCRESTAR
Study objectivesThe 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(s)Approved 17/02/2015, London - Surrey Research Ethics Committee (2 Redman Place, Stratford, London, E20 1JQ, United Kingdom; Tel: not applicable; surrey.rec@hra.nhs.uk), ref: 15/LO/0184
Health condition(s) or problem(s) studiedTopic: Metabolic and endocrine disorders; Subtopic: Metabolic and Endocrine (all Subtopics); Disease: Metabolic & Endocrine (not diabetes)
InterventionAdded 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 typeSupplement
Primary outcome measureCurrent 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 measuresAdded 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 study start date01/04/2015
Completion date01/09/2026

Eligibility

Participant type(s)Healthy volunteer
Age groupAdult
Lower age limit18 Years
Upper age limit65 Years
SexBoth
Target number of participantsPlanned Sample Size: 90; UK Sample Size: 90
Key inclusion criteria1. Body mass index (BMI) of 20-35 kg/m2
2. Age between 18-65 years (inclusive)
Key exclusion criteria1. 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.
Date of first enrolment01/04/2015
Date of final enrolment01/06/2026

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

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

Sponsor information

Imperial College London (UK)
Hospital/treatment centre

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

ROR logo "ROR" https://ror.org/041kmwe10

Funders

Funder type

Government

Biotechnology and Biological Sciences Research Council
Government organisation / National government
Alternative name(s)
UKRI - Biotechnology And Biological Sciences Research Council, BBSRC UK, BBSRC
Location
United Kingdom

Results and Publications

Intention to publish date31/12/2026
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planThe 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.
IPD sharing planThe datasets generated during and/or analysed during the current study will be available upon request from Katerina Petropoulou (katerina.petropoulou12@imperial.ac.uk).

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
HRA research summary 28/06/2023 No No
Other publications 26/10/2020 22/03/2024 Yes No

Editorial Notes

22/03/2024: The following changes were made to the study record:
1. Acronym, IRAS number, ethics approval details, intention to publish date, IPD sharing plan added.
2. The recruitment end date was changed from 01/04/2017 to 01/06/2026.
3. The overall study end date was changed from 01/04/2017 to 01/09/2026.
4. Publication reference added.
05/09/2023: The contact was updated.
04/07/2016: Plain English summary added.