Condition category
Digestive System
Date applied
17/06/2019
Date assigned
01/07/2019
Last edited
18/06/2019
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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

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

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

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

Publication citations

Additional files

Editorial Notes

18/06/2019: Trial’s existence confirmed by University of Leeds