Dietary resistant starch from peas for healthy glucose homeostasis
| ISRCTN | ISRCTN13747085 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13747085 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Integrated Research Application System (IRAS) | 168400 |
| Protocol serial number | CPMS 18551, IRAS 168400 |
| Sponsor | Imperial College London (UK) |
| Funder | Biotechnology and Biological Sciences Research Council |
- 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
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
Scientific
Imperial College of Science, Technology and Medicine
Du Cane Road
London
W12 0NN
United Kingdom
| Phone | +44 (0) 7428732523 |
|---|---|
| katerina.petropoulou12@imperial.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomized; Interventional; Design type: Treatment |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Dietary resistant starch from peas for healthy glucose homeostasis: a randomised controlled trial |
| Study acronym | CRESTAR |
| Study objectives | 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(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) studied | Topic: Metabolic and endocrine disorders; Subtopic: Metabolic and Endocrine (all Subtopics); Disease: Metabolic & Endocrine (not diabetes) |
| Intervention | 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 | Supplement |
| Primary outcome measure(s) |
Current primary outcome measures as of 04/07/2016: |
| Key secondary outcome measure(s) |
Added 04/07/2016: |
| Completion date | 01/09/2026 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 65 Years |
| Sex | All |
| Target sample size at registration | 90 |
| Key inclusion criteria | 1. Body mass index (BMI) of 20-35 kg/m2 2. Age between 18-65 years (inclusive) |
| Key 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. |
| Date of first enrolment | 01/04/2015 |
| Date of final enrolment | 01/06/2026 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
London
W12 0NN
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | The 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 | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
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.
