ObesityNCT03424187
The Acute Effects of Food Structure on Post Prandial Glucose and Subsequent Metabolic Responses
A study testing chickpea in people with Obesity, run by Imperial College London.
Trial summary
Aims: To investigate the effects of different food structures on glucose concentrations and subsequent metabolic responses including insulin,GIP, GLP-1 DESIGN: A randomised, controlled, clinical trial. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- chickpea
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- Jul 2016to Jul 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Gender: male and female
- Age ≥ 18 years ≤ 65 years
- Normal weight as classified by BMI 20-29.9 kg/m2
- Healthy, not diagnosed with any chronic diseases assessed as appropriate for inclusion, based on the pre-study screening.
- Willingness and ability to understand, participate and to comply with the study requirements
- Willingness and ability to give written informed consent
Who cannot join
- Has thyroid defects
- Under hormone or steroids therapy
- Is pregnant or lactating (female)
- Had given birth within the past year (female)
- Is taking drugs that could affect appetite or plasma glucose levels.
- Is taking natural remedies that modulate appetite or plasma glucose levels.
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- Has excessive alcohol intake
- Had blood donation within 12wks prior to start date
- Psychiatric illness
- Smokers
- History of any disease with unknown outcome
- Has diabetes
- Has nut allergy
About this study
Aims: To investigate the effects of different food structures on glucose concentrations and subsequent metabolic responses including insulin,GIP, GLP-1 DESIGN: A randomised, controlled, clinical trial.
Read the detailed description
Rationale:
There is very little evidence at the present time in the role of food structure in glucose homeostasis. There is circumstantial evidence that foods consumed intact have great effects on suppressing appetite.
To test the effect of three structurally different meals with the same nutritional content and volume on appetite regulation. Each participant will receive the following meals:
Solid meal group. Milled (intact-cell) meal group. Milled (destroyed-cell) meal group.
All of which will contain the same macro and micro nutrients from the same food sources
- Conditions
- Obesity
- Being tested
- chickpea
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
chickpeaDietary supplement
all three meals are isocaloric but different in the chickpea structure( physical form):
- Whole chickpea, flour chickpea, intact cell flour chickpea
| Study group | Role | What they receive |
|---|---|---|
| whole chickpea | Experimental | a test meal containing 26g available carbohydrates from chickpea (full structure) Receives: Dietary Supplement: chickpea |
| flour chickpea | Experimental | a test meal containing 26g available carbohydrates from flour chickpea (destroyed structure) Receives: Dietary Supplement: chickpea |
| intact cell chickpea | Experimental | a test meal containing 26g available carbohydrates from intact cell chickpea flour (full structure) Receives: Dietary Supplement: chickpea |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-prandial Glucose Concentrations
Blood glucose concentrations were assessed for each participant after each test meal: whole chickpea hummus, Flour chickpea hummus, and Intact cell chickpea hummus. Blood samples were collected before the introduction of the test meal and then at 15 minutes, 30 min, 60, 90, 120, and 180 minutes after the consumption of the test meal.
Data were not collected for intact cell chickpea hummus
Measured: before the consumption of the test meal and then 15 min, 30, 60,90, 120, 180 minutes after the consumption of the test meal.
Post-prandial Blood Insulin Concentrations
Blood glucose concentrations were assessed for each participant after each test meal: whole chickpea hummus, Flour chickpea hummus, and Intact cell chickpea hummus. Blood samples were collected before the introduction of the test meal and then at 15 minutes, 30 min, 60, 90, 120, and 180 minutes after the consumption of the test meal.
Measured: before the consumption of the test meal and then 15, 30, 60, 90, 120, and 180 minutes post consumption of test meal.
Secondary outcomes (3)
Post-prandial Gut Hormone Gastric Inhibitory Polypeptide (GIP)
Blood GIP concentrations were assessed for each participant after each test meal: whole chickpea hummus, and Flour chickpea hummus. Blood samples were collected before the introduction of the test meal and then at 15 minutes, 30 min, 60, 90, 120, and 180 minutes after the consumption of the test meal.
Data were not collected for intact cell chickpea hummus
Measured: before the consumption of the test meal at 0 min and then post test meal at 15, 30,60 ,90,120 and 180 minutes.
Post-prandial Gut Hormone Glucagon-like Peptide 1 (GLP-1)
Blood GLP-1 concentrations were assessed for each participant after each test meal: whole chickpea hummus, Flour chickpea hummus, and Intact cell chickpea hummus. Blood samples were collected before the introduction of the test meal and then at 15 minutes, 30 min, 60, 90, 120, and 180 minutes after the consumption of the test meal.
Measured: baseline before the consumption of the test meal, and then 15,30,60,90,120,180 min after the consumption of the test meal.
Energy Intake at a Meal Given in Excess
The difference in ad libitum food intake after 210 minutes post test meal to test the difference of energy intake following whole chickpea hummus, flour chickpea hummus, and intact cell chickpea hummus.
Measured: post consumption of the test meal at 120 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2018
- Study startJul 2016
- Primary completionMay 2017
- Study completionJul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03424187
- Sponsor's protocol ID
- 15HH3069
- Status last verified
- Mar 2021
- First submitted
- 1 Sep 2017
- Last updated
- 2 Apr 2021
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Alshaalan RA, Charalambides MN, Edwards CH, Ellis PR, Alrabeah SH, Frost GS. Impact of chickpea hummus on postprandial blood glucose, insulin and gut hormones in healthy humans combined with mechanistic studies of food structure, rheology and digestion kinetics. Food Res Int. 2024 Jul;188:114517. doi: 10.1016/j.foodres.2024.114517. Epub 2024 May 10.
PubMed 38823849
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Acute Effects of Food Structure on Post Prandial Glucose and Subsequent Metabolic Responses
- ClinicalTrials.gov ID
- NCT03424187
- Acronym / sponsor ID
- 15HH3069
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- Jul 2016 (actual)
- Primary completion
- May 2017 (actual)
- Study completion
- Jul 2018 (actual)
- First posted
- 6 Feb 2018 (actual)
- Results
- Posted 2 Apr 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Aims: To investigate the effects of different food structures on glucose concentrations and subsequent metabolic responses including insulin,GIP, GLP-1 DESIGN: A randomised, controlled, clinical trial.
Detailed description
Rationale:
There is very little evidence at the present time in the role of food structure in glucose homeostasis. There is circumstantial evidence that foods consumed intact have great effects on suppressing appetite.
To test the effect of three structurally different meals with the same nutritional content and volume on appetite regulation. Each participant will receive the following meals:
Solid meal group. Milled (intact-cell) meal group. Milled (destroyed-cell) meal group.
All of which will contain the same macro and micro nutrients from the same food sources
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| whole chickpea | Experimental | Dietary Supplement: chickpeaa test meal containing 26g available carbohydrates from chickpea (full structure) |
| flour chickpea | Experimental | Dietary Supplement: chickpeaa test meal containing 26g available carbohydrates from flour chickpea (destroyed structure) |
| intact cell chickpea | Experimental | Dietary Supplement: chickpeaa test meal containing 26g available carbohydrates from intact cell chickpea flour (full structure) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Gender: male and female
- Age ≥ 18 years ≤ 65 years
- Normal weight as classified by BMI 20-29.9 kg/m2
- Healthy, not diagnosed with any chronic diseases assessed as appropriate for inclusion, based on the pre-study screening.
- Willingness and ability to understand, participate and to comply with the study requirements
Key exclusion criteria (13 listed)
- Has thyroid defects
- Under hormone or steroids therapy
- Is pregnant or lactating (female)
- Had given birth within the past year (female)
- Is taking drugs that could affect appetite or plasma glucose levels.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| chickpeaall three meals are isocaloric but different in the chickpea structure( physical form): • Whole chickpea, flour chickpea, intact cell flour chickpea | Dietary supplement | flour chickpea, intact cell chickpea, whole chickpea |
Primary outcome
Post-prandial Glucose Concentrations
Time frame: before the consumption of the test meal and then 15 min, 30, 60,90, 120, 180 minutes after the consumption of the test meal.
Blood glucose concentrations were assessed for each participant after each test meal: whole chickpea hummus, Flour chickpea hummus, and Intact cell chickpea hummus. Blood samples were collected before the introduction of the test meal and then at 15 minutes, 30 min, 60, 90, 120, and 180 minutes after the consumption of the test meal. Data were not collected for intact cell chickpea hummus
Post-prandial Blood Insulin Concentrations
Time frame: before the consumption of the test meal and then 15, 30, 60, 90, 120, and 180 minutes post consumption of test meal.
Blood glucose concentrations were assessed for each participant after each test meal: whole chickpea hummus, Flour chickpea hummus, and Intact cell chickpea hummus. Blood samples were collected before the introduction of the test meal and then at 15 minutes, 30 min, 60, 90, 120, and 180 minutes after the consumption of the test meal.
3 secondary outcomes
Post-prandial Gut Hormone Gastric Inhibitory Polypeptide (GIP)
Time frame: before the consumption of the test meal at 0 min and then post test meal at 15, 30,60 ,90,120 and 180 minutes.
Post-prandial Gut Hormone Glucagon-like Peptide 1 (GLP-1)
Time frame: baseline before the consumption of the test meal, and then 15,30,60,90,120,180 min after the consumption of the test meal.
Energy Intake at a Meal Given in Excess
Time frame: post consumption of the test meal at 120 minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38823849Alshaalan RA, Charalambides MN, Edwards CH, Ellis PR, Alrabeah SH, Frost GS. Impact of chickpea hummus on postprandial blood glucose, insulin and gut hormones in healthy humans combined with mechanistic studies of food structure, rheology and digestion kinetics. Food Res Int. 2024 Jul;188:114517. doi: 10.1016/j.foodres.2024.114517. Epub 2024 May 10.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing chickpea in people with Obesity, run by Imperial College London.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-prandial Glucose Concentrations (time frame: before the consumption of the test meal and then 15 min, 30, 60,90, 120, 180 minutes after the consumption of the test meal.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03424187, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2021; AzTrials last refreshed its copy on 7 Nov 2026.