Plain English Summary
Background and study aims
Pulses are dry edible seeds of leguminous plants, characterised by high content of complex carbohydrate, dietary fibre, protein and micronutrient contents. Evidence suggests that their consumption may beneficially impact on blood sugar (glycaemic response) following a meal in healthy and diabetic people. However, it has been suggested that different food processing methods might impact on carbohydrate availability for digestion and therefore the glucose response.
This study aims to investigate the effect of pulse consumption such as (kidney beans and chickpeas) on the 24h glucose response, measured by continuous glucose monitoring technique. We will compare the pulses that have been prepared using different domestic cooking techniques such as (boiling, pressure cooking, canning, and legume flour pasta).
Who can participate?
Healthy male and female adults with 18-30 BMI.
What does the study involve?
Each subject will visit the research centre 4 times, each time consuming a different food in random order (3 pulse samples and white bread or potato as control). The food will be prepared by the researcher at the University of Leeds in the Food Technology Laboratory (G08, Food Science Building).
What are the possible benefits and risks of participating?
There are no direct benefits to participants but the information obtained will help to better understand the possible effect of legumes on blood glucose.
Risks of the include minor possibility of experiencing discomfort or light bleeding from finger pricks or continuous glucose monitoring device. The restriction of food intake during the three hours of the test may result in hunger but this is a short period of fasting and therefore no risk is anticipated. Participants will complete a health questionnaire to exclude individuals with a potential allergy to the test foods or any other conditions which may increase the risk of adverse effects.
Where is the study run from?
School of Food Science and Nutrition, University of Leeds, UK.
When is the study starting and how long is it expected to run for?
June 2019 to November 2019
Who is funding the study?
King Abdulaziz University, Saudi Arabia
Who is the main contact?
Ms Maryam Hafiz
fs16msyh@leeds.ac.uk
Trial website
Contact information
Type
Scientific
Primary contact
Mrs Maryam Hafiz
ORCID ID
http://orcid.org/0000-0002-5769-175X
Contact details
School of food science and nutrition
University of Leeds
Leeds
LS2 8WG
United Kingdom
0113 343 3399
fs16msyh@leeds.ac.uk
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
MEEC 18-035
Study information
Scientific title
Effect of acute consumption of legumes with different processing on post-prandial glycaemic profile
Acronym
Study hypothesis
The different processing methods of the different legumes will affect the post-prandial glycaemic levels
Ethics approval
Approved 22/05/2019, University of Leeds Research Ethics Committee (University of Leeds Leeds, LS2 9JT, UK; +44113 3431642; MEECResearchEthics@leeds.ac.uk), ref: MEEC 18-035.
Study design
Single-centre randomised cross-over trial
Primary study design
Interventional
Secondary study design
Randomised cross over trial
Trial setting
Other
Trial type
Other
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Healthy volunteers
Intervention
Current interventions as of 04/10/2019:
The study will be a randomized, cross-over dietary intervention on 25 participants. Each subject will require coming for 4 visits control, and 3 different processing (canned, pureed, and pasta) of chickpeas over a period of 2 weeks, the order of which will be randomized using a computer to assess the post-prandial and 24h glycaemic effect by using continuous glucose monitors. The food will be prepared in the food tech lab at the University of Leeds according to the procedure followed by the food lab to avoid any risk of contamination. Before a test day, participants will be asked to fast overnight, to refrain from strenuous exercise for 24 hours and to refrain from drinking alcohol during the evening before the study visit. On each visit, a cannula will be inserted in the arm of the participant for blood collection at the beginning of each visit and will be removed after 3 hours. A small blood sample will be taken from the cannula, then they will be asked to consume either freshly prepared beans or chickpeas, canned beans or chickpeas or bean or chickpeas made pasta or white wheat bread or potatoes only provided by the researcher. They will also be asked to abstain from all foods (can drink water) during following 3 hours. After that, few blood sample will be taken by inserted cannula at 30, 60, 90, 120, 150 and 180min after eating. The procedure will be conducted on weekdays only with test food given alternatively at each session. They will be asked to answer some questionnaires related to food intake.
Previous interventions:
The study will be a randomized, cross-over dietary intervention on 25 participants. Each subject will require coming for 4 visits control, and 3 different processing (canned, pureed, and pasta) of chickpeas over a period of 2 weeks, the order of which will be randomized using a computer to assess the post-prandial and 24h glycaemic effect by using continuous glucose monitors. The food will be prepared in the food tech lab at the University of Leeds according to the procedure followed by the food lab to avoid any risk of contamination. Before a test day, participants will be asked to fast overnight, to refrain from strenuous exercise for 24 hours and to refrain from drinking alcohol during the evening before the study visit. Their blood glucose will be measured on arrival the following morning by taking blood via a finger prick test then small device for continuous glucose monitoring will be attached to their upper arm by qualified practitioner (it will remain inserted there until they finish all four visits within two weeks, instructions about it will be provided) and a blood sample will be taken. Then they will be asked to consume either pureed chickpeas, canned chickpeas or chickpeas made pasta or potatoes only provided by the researcher. They will also be asked to abstain from all foods (can drink water) during the following 3 hours. Two more blood samples will be taken at 90 min and 180 min after eating. The procedure will be conducted on weekdays only with test food given alternatively at each session. They will be asked to answer some questionnaires related to food intake.
Intervention type
Other
Phase
Drug names
Primary outcome measure
Current primary outcome measure as of 04/10/2019:
Post-prandial glucose peak measured by continuous glucose monitoring system at 30, 60, 90, 120, 150 and 180min after eating
Previous primary outcome measure:
Blood glucose will be measured on arrival the following morning by taking blood via a finger prick test then small device for continuous glucose monitoring will be attached to their upper arm by qualified practitioner. Two more blood sample will be taken at 90 min and 180 min after eating
Secondary outcome measures
1. Insulin and satiety hormones measured using the same blood samples collected as above.
2. Inflammatory markers measured using the same blood samples collected as above.
3. Food habits measured by the food frequency questionnaire during each visit.
Overall trial start date
01/02/2018
Overall trial end date
30/12/2019
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Aged >= 18 years
2. Healthy
3. BMI 18 - 30
Participant type
Healthy volunteer
Age group
Adult
Gender
Both
Target number of participants
25
Total final enrolment
19
Participant exclusion criteria
1. Regular drug therapy
2. Diabetes (fasting glucose >126 mg/dL, or anti-diabetic treatment)
3. Hypothydroidism or thyroxine treatment
4. Ill or suffer from any underlying health condition that can affect their ability to taste, smell, chew, digest or excrete of food
5. History of cancer or cancer treatment
6. Active or recently diagnosed intestinal malabsorption or disorders associated with malabsorption: Crohn’s disease, short bowel syndrome, Pancreatic insufficiency, cystic fibrosis, Tropical Sprue, whipple’s disease, chronic pancreatitis, gastrojejunostomy, surgical treatments for obesity, cholestasis, biliary atresia, parasite infections, HIV/AIDS
7. Use of medication known to cause malabsorption: tetracycline, cholestyramine, thiazide diuretics, aluminium/magnesium hydroxide, colchicine, neomycin, methotrexate, methyldopa, and allopurinol, and laxatives
8. Illegal drug use or chronic alcoholism
9. History of allergy or intolerance to any components used in the study
10. Women who are pregnant, lactating or actively trying to conceive
11. Participation in other clinical trials that may impact on outcome
Recruitment start date
16/07/2019
Recruitment end date
30/11/2019
Locations
Countries of recruitment
United Kingdom
Trial participating centre
School of Food Science and Nutrition
University of Leeds
Leeds
LS2 9JT
United Kingdom
Sponsor information
Organisation
King Abdulaziz University
Sponsor details
Jeddah
Jeddah
21589
Saudi Arabia
+966126400000
mshafiz@kau.edu.sa
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
King Abdulaziz University
Alternative name(s)
King Abdulaziz University of Saudi Arabia, KAU
Funding Body Type
government organisation
Funding Body Subtype
government non-federal
Location
Saudi Arabia
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer-reviewed journal
IPD sharing statement:
All data generated or analysed during this study will be included in the subsequent results publication
Intention to publish date
30/12/2020
Participant level data
Other
Basic results (scientific)
Publication list