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
Type
Scientific
Primary contact
Dr Edward Chambers
ORCID ID
http://orcid.org/0000-0001-7074-1312
Contact details
Imperial College of Science
Technology and Medicine
Du Cane Road
London
W12 0NN
United Kingdom
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
18551
Study information
Scientific title
Dietary resistant starch from peas for healthy glucose homeostasis: a randomised controlled trial
Acronym
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
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details to request a patient information sheet
Condition
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
Phase
Drug names
Primary outcome measures
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
01/04/2015
Overall trial end date
01/04/2017
Reason abandoned
Eligibility
Participant inclusion criteria
1. Body mass index (BMI) of 20-35 kg/m2
2. Age between 18-65 years (inclusive)
Participant type
Patient
Age group
Adult
Gender
Both
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
01/04/2015
Recruitment end date
01/04/2017
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Imperial College of Science, Technology and Medicine
Du Cane Road
London
W12 0NN
United Kingdom
Funders
Funder type
Government
Funder name
Biotechnology and Biological Sciences Research Council
Alternative name(s)
BBSRC
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
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
Results - basic reporting
Publication summary