Condition category
Digestive System
Date applied
22/01/2020
Date assigned
11/02/2020
Last edited
11/02/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
A number of reports globally demonstrate the rates of obesity and type 2 diabetes continue to increase. It highlights the importance of the maintenance of an energy balance and glucose homeostasis. Chickpeas are high in resistant starches and protein, and these nutrients have been shown to stimulate gut hormone secretion that could regulate glucose homeostasis. Therefore, this study aims to investigate the impact of different chickpea tissue-structures on gut hormone secretion, thus explaining the chickpeas’ influences on glucose control and satiety reported in previous studies. This project will improve understanding of the relationship among food structure ranging in processing, nutrient bioavailability and chickpea-induced release of gut hormone.

Who can participate?
People aged 18 – 65 years with a BMI of 18 – 30 kg/m²

What does the study involve?
This study is to test the physiological effects of three chickpea-based meals that different in processing and microstructures. This is a randomised crossover study therefore every participant will receive the same treatments.

What are the possible benefits and risks of participating?
Benefits: Taking part in the study will provide no direct benefit for you. The information that we get from this study will help us to better understand normal appetite regulation and may help us to better treat future patients who suffer from obesity. If any of the screening questionnaires or blood tests reveal any medical problems (e.g. diabetes, kidney or liver problems), your GP will be informed so that they can coordinate your further care, arrange any further tests, and refer you on to Hospital Doctors if necessary.
Risks: The diets consumed over the course of the study are common food items and dietary supplements. They are generally not found to be linked to any serious side effects.
Insertion of the cannula into participants’ arms on each of the study visits may cause minor discomfort or superficial bruising. Serious risks associated with the insertion of the ensonetric tubes are very rare and almost negligible. These risks include bleeding, perforation or damage to the base of the skull. Minor discomfort of the back of the throat does occur in the majority of patients and may result transiently in a sore mouth, thirst, swallowing difficulties or hoarseness. The fluoroscopy procedure will expose participants to a small dose of radiation. The mean effective dose from each nasogastric tube procedure is equivalent to 2.8 months of natural background radiation (the same amount as you would be exposed to walking around outside) and would increase the risk of inducing cancer by 0.0025% (or 1 in 40,000). The minimum number of fluoroscopy procedures that will be conducted is 3. The maximum number of fluoroscopy procedures that will be conducted is 6.

Where is the study run from?
Imperial College NIHR/Wellcome Trust Imperial Clinical Research Facility, Hammersmith Hospital, UK

When is the study starting and how long is it expected to run for?
October 2019 to October 2021

Who is funding the study?
1. Biotechnology and Biological Sciences Research Council, UK
2. National Institute for Health Research (NIHR), UK

Who is the main contact?
Miss Mingzhu Cai (public)
m.cai18@imperial.ac.uk
Prof. Gary Frost (scientific)
g.frost@imperial.ac.uk

Trial website

Contact information

Type

Public

Primary contact

Miss Mingzhu Cai

ORCID ID

https://orcid.org/0000-0002-1474-0224

Contact details

Commonwealth Building
Imperial College Hammersmith Campus
Du cane Road
London
W12 0NN
United Kingdom
+44 (0)7395757128
m.cai18@imperial.ac.uk

Type

Scientific

Additional contact

Prof Gary Frost

ORCID ID

https://orcid.org/0000-0003-0529-6325

Contact details

Commonwealth Building
Imperial College Hammersmith Campus
Du cane Road
London
W12 0NN
United Kingdom
+44 (0)20 8383 8037
g.frost@imperial.ac.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

6, IRAS 256533, CPMS 42519

Study information

Scientific title

Determining the effect of chickpea tissue-structures on metabolic responses, satiety regulation and gut content along the entire gastrointestinal tract on healthy participants

Acronym

Study hypothesis

Micro-structures of chickpea that are more resistant to digestion can improve glucose response and prolong appetite.

Ethics approval

Approved 31/07/2019, London-Camden and Kings-Cross Research Ethics Committee (Health Research Authority, Skipton House, 80 London Road, London, SE1 6LH; +44 (0)20 7104 8222; nrescommittee.london-camdenandkingscross@nhs.net), ref:19/LO/0962

Study design

Single-centre randomised crossover nutritional-intervention study

Primary study design

Interventional

Secondary study design

Randomised cross over trial

Trial setting

Hospitals

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Digestion in healthy participants

Intervention

This study consists of one 4-day study visit and three 3-day study visits. At least one week’s gap is needed. The 4-day study visit will mainly look at the upper gastro-intestine (GI) while the 3-day ones will look at the lower GI.

During each study visit, chickpeas-based meals in different structures (broken cells, intact cells, and cell clusters) will be served to participants. Then the physiological responses will be investigated:
Bloods will be taken to measure the post-prandial glucose, insulin, gut hormone and metabolites;
Guts samples will be taken through a nasoenteric tube to monitor the digestive behaviours and structures breakdown; VAS will be conducted to measure subjective appetite; Urine and stool samples will be collected to measure the metabolites.

Randomisation is conducted using the website of sealed envelope: https://www.sealedenvelope.com/

Intervention type

Other

Phase

Drug names

Primary outcome measure

Appetite-regulating gut hormones measured using RIA assay in the intestinal contents that will be collected through a nasoenteric tube at 0, 60, 120, 180, 240, 300, 420, 480 min at each study day

Secondary outcome measures

1. Circulating concentrations of glucose, insulin, and metabolites measured using ci8200 analyser enzymatic method, RIA assay, and GC-MS respectively at 0, 60, 120, 180, 240, 300, 420, 480 min at each study day
2. Subjective measures of appetite, as assessed by Visual Analogue Scales (VAS) at 0, 60, 120, 180, 240, 300, 420, 480 min at each study day
3. Energy intake as determined by an ad libitum meal at 240 min at each study day

Overall trial start date

01/07/2019

Overall trial end date

30/12/2021

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Age between 18 - 65 years (inclusive)
2. Body mass index (BMI) of 18-30 kg/m²
3. Willingness and ability to give written informed consent and willingness and ability to understand, to participate and to comply with the study requirements

Participant type

Healthy volunteer

Age group

Adult

Gender

Both

Target number of participants

15

Participant exclusion criteria

1. Abnormal ECG
2. Screening blood results outside of normal reference values
3. Weight change of ≥ 5kg in the preceding 2 months
4. Current smokers
5. History of substance abuse and/or excess alcohol intake • Pregnancy • Diabetes • Cardiovascular disease
6. Cancer
7. Gastrointestinal disease e.g. inflammatory bowel disease or irritable bowel syndrome
8. Kidney disease
9. Liver disease
10. Pancreatitis
11. Started new medication within the last 3 months likely to interfere with energy metabolism, appetite regulation and hormonal balance, including anti-inflammatory drugs or steroids, antibiotics, androgens, phenytoin, erythromycin or thyroid hormones
12. Participation in a research study in the 12 week period prior to entering this study
13. Any blood donation within the 12 week period prior to entering this study

Recruitment start date

30/10/2019

Recruitment end date

31/12/2021

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Imperial College NIHR/Wellcome Trust Imperial Clinical Research Facility
Hammersmith Hospital Du Cane Rd Shepherd's Bush
London
W12 0NN
United Kingdom

Sponsor information

Organisation

Imperial College London

Sponsor details

Joint Research Compliance Office
Imperial College London and Imperial College Healthcare NHS Trust
London
W2 1PG
United Kingdom
+44 (0)207 594 1872
becky.ward@imperial.ac.uk

Sponsor type

University/education

Website

http://www3.imperial.ac.uk/

Funders

Funder type

Research council

Funder name

Biotechnology and Biological Sciences Research Council

Alternative name(s)

BBSRC

Funding Body Type

government organisation

Funding Body Subtype

National government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

The study results will be published in a PhD thesis and 1-2 scientific papers in peer-reviewed journals.

IPD sharing statement:
The datasets generated during and/or analysed during the current study will be stored in a non-publically available repository.

Intention to publish date

30/09/2022

Participant level data

Stored in repository

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

11/02/2020: Uploaded protocol (not peer reviewed) as an additional file. 06/02/2020: Trial’s existence confirmed by London-Camden and Kings-Cross Research Ethics Committee.