Postprandial PeriodNCT03994276
The Postprandial Effects of Chick-Pea Consumption on Glucose, Insulin, and Gut Hormone Responses (PEA-POD).
A study testing Chickpea powder in people with Postprandial Period, run by King's College London at 1 site in United Kingdom.
Trial summary
Pulses have a high fibre content, contribute to lowering fasting blood cholesterol levels and improving glycaemic control, and have shown also considerable promise in supporting the dietary management of cardiovascular disease (CVD), type-2 diabetes mellitus (T2DM) and obesity. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Postprandial Period
- What is being tested?
- Chickpea powder
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 29 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 25 Jun 2019to 20 May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age: 18-45 y
- Men and women
- Healthy (free of diagnosed diseases listed in the exclusion criteria)
- Body Mass Index 18-35 kg/m2
- Able to understand the information sheet and willing to comply with study protocol
- Able to give informed written consent
Who cannot join
- Those with known or suspected food allergies (particularly to wheat, as specified in the screening questionnaire and participant information form) or hypersensitivity
- Women who are pregnant, intending to become pregnant, or breastfeeding
- Participation in another clinical trial
- Those who have donated blood within 3 months of the screening visit and participants for whom participation in this study would result in having donated more than 1500 millilitres of blood in the previous 12 months.
- Body mass index <18 or >35 kg/m2
- Full Blood Counts and Liver Function test results outside of the normal range.
Show all 13Show fewer
- Current smokers, or reported giving up smoking within the last 6 months History of substance abuse or alcoholism
- Reported history of Cardiovascular disease, diabetes (or fasting glucose ≥ 7.1 mmol/L), cancer, kidney, liver or bowel disease, gastrointestinal disorder or use of drug likely to alter gastrointestinal function)
- Blood pressure ≥160/100 mmHg
- Total cholesterol ≥ 7.8 mmol/L; fasting triacylglycerol concentrations ≥ 5.0 mmol/L
- Medications that may interfere with the study: alpha-glucosidase inhibitors (acarbose:
- Glucobay), insulin- sensitising drugs (metformin: Glucophage, Glucophage SR, Eucreas, Janumet; thiazolidinediones: Actos, Competact), sulfonylureas (Daonil, Diamicron, Diamicron MR, Glibenese, Minodiab, Amaryl Tolbutamide), and lipid- lowering drugs (statins, nicotinic acid, colestyramine anhydrous, ezetimibe, fibrates).
- Other medications should be reviewed by a medical representative from KCL on a case by case basis.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Metabolic Research Unit
London, Please Choose, SE1 9NH
About this study
Official title: The Postprandial Effects After Consumption of Chick-Pea Oral Doses on Glucose, Insulin, and Gut Hormone Responses. The PEA-POD Study
Pulses have a high fibre content, contribute to lowering fasting blood cholesterol levels and improving glycaemic control, and have shown also considerable promise in supporting the dietary management of cardiovascular disease (CVD), type-2 diabetes mellitus (T2DM) and obesity. It is now established that cellular integrity (maintenance of cell wall structure) is a key factor responsible for the low glycaemic index (GI) of pulses. The maintenance of the cell wall structure restricts starch digestion and therefore glucose production in the gut. Thus, cell damage results in a loss of such properties and also the potential health benefits to consumers.
This knowledge has presented an opportunity to exploit alternative processing techniques for the manufacture of pulse-based ingredients. We have successfully created a dry powder consisting predominantly of intact cells which still retains low digestibility (>60% resistant starch). This chickpea powder (CPP) was found to be stable under long-term storage, has a neutral taste and aroma, and showed promise as a low GI 'flour-substitute'.
This study will investigate blood sugar, insulin and gut hormone levels (post-prandial glycaemic, insulinaemic and hormone responses) following the consumption of CPP consumed at breakfast, as a drink and incorporated into a food matrix (bread).
Read the detailed description
The nutritional and potential long-term health benefits of consuming pulses have been well documented. Pulses have a high fibre content, contribute to lowering fasting blood cholesterol levels and improving glycaemic control, and have shown also considerable promise in supporting the dietary management of cardiovascular disease (CVD), type-2 diabetes mellitus (T2DM) and obesity. They are gluten-free and are also an affordable and accessible source of starch, protein, and dietary fibre. It is now established that cellular integrity (maintenance of cell wall structure) is a key factor responsible for the low glycaemic index (GI) of pulses. The maintenance of the cell wall structure restricts starch digestion and therefore glucose production in the gut. Thus, cell damage (i.e. as occurs extensively during milling of pulses into flour) results in a loss of such properties and also the potential health benefits to consumers.
This knowledge has presented an opportunity to exploit alternative processing techniques for the manufacture of pulse-based ingredients that preserve the desirable low GI of whole pulses. Incorporation of such ingredients has the potential to lower the glycaemic and insulinaemic responses to staple food products and/or may promote satiety, thereby ameliorating the dietary management of T2D and obesity and reducing the risk factors associated with these diseases. Building on new understanding of the conditions required to preserve cellular integrity, we have successfully created a dry powder consisting predominantly of intact cells which still retains low digestibility (>60% resistant starch). This chickpea powder (CPP) was found to be stable under long-term storage, has a neutral taste and aroma, and showed promise as a low GI 'flour-substitute'.
This study will investigate blood sugar, insulin and gut hormone levels (post-prandial glycaemic, insulinaemic and hormone responses) following the consumption of CPP consumed as a drink and incorporated into a food matrix (bread). It is hypothesised that the structure of the CCP will result in a reduced post-prandial glycaemic response, while maintaining (or improving) the insulinaemic and gut hormone responses. This regulation of blood sugar levels following a meal would be beneficial for people with impaired glucose metabolism, such as T2DM. This study will consist of two phases, both utilising a three-arm, random crossover design.
Phase 1 aims to test the glucose response to unmodified CPP (i.e. has not been cooked). This will involve the consumption of the following test drinks containing 50g of available carbohydrate (i.e. starch and/or sugars): (1) Glucose (an oral glucose tolerance test, OGTT); (2) Control chickpea product (no cellular integrity); and (3) the CPP. These test drinks will be consumed in random order on three separate visits. In order to ensure the test carbohydrates remains in solution, all test drinks will be made up in an equivalent volume of 330 ml (bottled water) containing chocolate flavouring. Participants will be required to fast overnight, a capillary blood glucose measurement will be taken at t=0, followed by consumption of the test drink within 5 min. Further capillary blood glucose measurements will be taken at t=10, 20, 30, 45, 60, 90, and 120 min. Additionally, participants will be provided with a Constant Glucose Monitor (CGM) that will be applied to the upper arm 24hrs prior to the first study day. All three study visits will be completed in 12 days (The length of CGM activity). It is hypothesised that the cell wall integrity in the CPP drink will result in a reduced post-prandial glycaemic response compared to the control chickpea product and the OGTT standard.
Outcome measures: The primary outcome of Phase 1 will be the glycaemic response to the consumption of CPP drink compared to both the OGTT and control chickpea product. In vitro studies suggest that maintenance of cellular integrity will reduce the early phase of post-prandial glycaemia, as assessed by the incremental area under the curve (iAUC) iAUC0-60min and maximum blood glucose concentration (Cmax). Secondary measures such as the time to reach maximum blood glucose concentration (Tmax), iAUC0-120min and iAUC60-120min will also be assessed.
Phase 2 aims to test the glucose, insulin and gut hormone response to CPP incorporated into a staple food. This will involve the consumption of wheat-based breads containing 50g of available carbohydrate and either; (1) wheat bread (control) (2) wheat bread with 30% CPP substitution of wheat flour, and (3) wheat bread with 60% CPP substitution of wheat flour. These breads will be consumed as part of a breakfast following an overnight fast on three separate study visits. Post-prandial concentrations of plasma glucose, insulin, glucose-dependent insulinotropic peptide (GIP), glucagon-like peptide 1 (GLP-1), peptide YY (PYY) and C-peptide will be measured; at commencement of meal, t=0, and following consumption at, t=15, 30, 45, 60, 90, 120, 180, and 240 min. Additionally, participants will be provided with a Constant Glucose Monitor (CGM) that will be applied to the upper arm 24hrs prior to each study day.
Outcome measures: The primary outcome of Phase 2 will be iAUC0-60min for plasma glucose concentrations and corresponding plasma insulin/C-peptide responses, demonstrating the ability of cell wall integrity to limit starch digestion, and therefore, the rate of glucose appearance in the blood in the early phase of post-prandial glycaemia. Secondary outcome variables include iAUC0-120min, iAUC0-240min, 30-90 and 90-240, Cmax, Tmax changes from baseline up to 240 min for plasma glucose, insulin, and C-peptide concentrations. For the gut hormones plasma GIP, PYY and GLP-1 concentrations will be assessed using the same outcome variables. Subjective measures of study meals and ad libitum meal palatability will be collected at t=10 min and post lunch, respectively. Subjective measures of mood, satiety and digestive comfort will be collected t=0, 10, 30, 60, 120, 180, 210, 240 min and post lunch. The energy intake from the ad libitum lunch provided following the experimental period will also be compared. Subjective measures will be summarised using descriptive statistics.
- Conditions
- Postprandial Period
- Being tested
- Chickpea powder
- Keywords
- Chickpea, Cell Wall, Dietary Fibre, Postprandial, Metabolism, Enteroendocrine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chickpea powderDietary supplement
Chickpea powder is produce using novel production techniques to maintain chickpea cell structure. It will be incorporated into a drink (Dextrose control), or baked into bread rolls at 30% or 60% substitution of wheat flour(100% Wheat flour control).
| Study group | Role | What they receive |
|---|---|---|
| Phase 1: Control | Placebo comparator | oral glucose tolerance test (OGTT): 58g Dextrose in 330ml water Receives: Dietary Supplement: Chickpea powder |
| Phase1: Chickpea Control | Active comparator | "sub-cellular" Chickpea powder: 58g total available carbohydrate, provided as 50g from chickpea powder + 8g from chocolate flavouring Receives: Dietary Supplement: Chickpea powder |
| Phase1: Chickpea Powder | Experimental | Chickpea powder: 58g total available carbohydrate, provided as 50g from chickpea powder + 8g from chocolate flavouring Receives: Dietary Supplement: Chickpea powder |
| Phase 2: Control | Active comparator | Wheat bread: breakfast consisting of a 100% wheat bread roll containing 54g available carbohydrate + 20g diabetic strawberry jam containing 2g sugar + 360ml water Receives: Dietary Supplement: Chickpea powder |
| Phase 2: 30%Chickpea Powder | Experimental | Wheat bread: breakfast consisting of a 70% wheat / 30% Chickpea powder bread roll containing 54g available carbohydrate + 20g diabetic strawberry jam containing 2g sugar + 360ml water Receives: Dietary Supplement: Chickpea powder |
| Phase 2: 60%Chickpea Powder | Experimental | Wheat bread: breakfast consisting of a 40% wheat / 60% Chickpea powder bread roll containing 54g available carbohydrate + 20g diabetic strawberry jam containing 2g sugar + 360ml water Receives: Dietary Supplement: Chickpea powder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 1: Postprandial Glycaemia (iAUC 0-60min)
The primary endpoint is iAUC 0-60 min for plasma glucose concentrations
Measured: 60 min
Phase 2: Postprandial Glycaemia / Insulinaemia (iAUC 0-60min)
The primary endpoint is iAUC 0-60 min for plasma glucose, Insulin, c-peptide and Gut hormone concentrations
Measured: 60 min
Secondary outcomes (10)
Phase 1: Postprandial Glycaemia (iAUC 0-120min)
iAUC 0-120 min for plasma glucose concentrations
Measured: 120 min
Phase 1: Postprandial Glycaemia (iAUC 60-120min)
iAUC 60-120 min for plasma glucose concentrations
Measured: 60 min
Phase 1: Postprandial Glycaemia (Cmax)
Cmax for plasma glucose concentrations
Measured: 120 min
Phase 1: Postprandial Glycaemia (Tmax)
Tmax for plasma glucose concentrations
Measured: 120 min
Phase 2: Postprandial Glycaemia / Insulinaemia (iAUC 0-120min)
iAUC 0-120 min for plasma glucose, Insulin, c-peptide and Gut hormone concentrations
Measured: 120 min
Phase 2: Postprandial Glycaemia / Insulinaemia (iAUC 0-240min)
iAUC 0-240 min for plasma glucose, Insulin, c-peptide and Gut hormone concentrations
Measured: 240 min
Phase 2: Postprandial Glycaemia / Insulinaemia (iAUC 30-90min)
iAUC 30-90 min for plasma glucose, Insulin, c-peptide and Gut hormone concentrations
Measured: 60 min
Phase 2: Postprandial Glycaemia / Insulinaemia (iAUC 90-240min)
iAUC 90-240 min for plasma glucose, Insulin, c-peptide and Gut hormone concentrations
Measured: 150 min
Phase 2: Postprandial Glycaemia / Insulinaemia (Cmax)
Cmax for plasma glucose, Insulin, c-peptide and Gut hormone concentrations
Measured: 240 min
Phase 2: Postprandial Glycaemia / Insulinaemia (Tmax)
Tmax for plasma glucose, Insulin, c-peptide and Gut hormone concentrations
Measured: 240 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2019
- Study start25 Jun 2019
- Primary completion10 Feb 2020
- Study completion20 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postprandial PeriodStudies of the same condition, open and under way.
- More trials run by King's 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
- Model description
- Cross-over design: Each participant will receive a control plus 2 treatments
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Collaborators
- Quadram Institute Bioscience, New-Food Innovation, Biotechnology and Biological Sciences Research Council
- Responsible party
- Sponsor
- Investigators
- Peter Ellis, PhD, Principal investigator, King's College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03994276
- Sponsor's protocol ID
- HR-18/19-8431
- Status last verified
- Jun 2019
- First submitted
- 20 Jun 2019
- Last updated
- 2 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bajka BH, Pinto AM, Perez-Moral N, Saha S, Ryden P, Ahn-Jarvis J, van der Schoot A, Bland C, Berry SE, Ellis PR, Edwards CH. Enhanced secretion of satiety-promoting gut hormones in healthy humans after consumption of white bread enriched with cellular chickpea flour: A randomized crossover study. Am J Clin Nutr. 2023 Mar;117(3):477-489. doi: 10.1016/j.ajcnut.2022.12.008. Epub 2022 Dec 28.
PubMed 36811474
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Postprandial Effects After Consumption of Chick-Pea Oral Doses on Glucose, Insulin, and Gut Hormone Responses. The PEA-POD Study
- ClinicalTrials.gov ID
- NCT03994276
- Acronym / sponsor ID
- HR-18/19-8431
- Conditions
- Postprandial Period
- Keywords
- Chickpea, Cell Wall, Dietary Fibre, Postprandial, Metabolism, Enteroendocrine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Collaborators
- Quadram Institute Bioscience, New-Food Innovation, Biotechnology and Biological Sciences Research Council
- Study start
- 25 Jun 2019 (actual)
- Primary completion
- 10 Feb 2020 (actual)
- Study completion
- 20 May 2020 (actual)
- First posted
- 21 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Pulses have a high fibre content, contribute to lowering fasting blood cholesterol levels and improving glycaemic control, and have shown also considerable promise in supporting the dietary management of cardiovascular disease (CVD), type-2 diabetes mellitus (T2DM) and obesity. It is now established that cellular integrity (maintenance of cell wall structure) is a key factor responsible for the low glycaemic index (GI) of pulses. The maintenance of the cell wall structure restricts starch digestion and therefore glucose production in the gut. Thus, cell damage results in a loss of such properties and also the potential health benefits to consumers.
This knowledge has presented an opportunity to exploit alternative processing techniques for the manufacture of pulse-based ingredients. We have successfully created a dry powder consisting predominantly of intact cells which still retains low digestibility (>60% resistant starch). This chickpea powder (CPP) was found to be stable under long-term storage, has a neutral taste and aroma, and showed promise as a low GI 'flour-substitute'.
This study will investigate blood sugar, insulin and gut hormone levels (post-prandial glycaemic, insulinaemic and hormone responses) following the consumption of CPP consumed at breakfast, as a drink and incorporated into a food matrix (bread).
Detailed description
The nutritional and potential long-term health benefits of consuming pulses have been well documented. Pulses have a high fibre content, contribute to lowering fasting blood cholesterol levels and improving glycaemic control, and have shown also considerable promise in supporting the dietary management of cardiovascular disease (CVD), type-2 diabetes mellitus (T2DM) and obesity. They are gluten-free and are also an affordable and accessible source of starch, protein, and dietary fibre. It is now established that cellular integrity (maintenance of cell wall structure) is a key factor responsible for the low glycaemic index (GI) of pulses. The maintenance of the cell wall structure restricts starch digestion and therefore glucose production in the gut. Thus, cell damage (i.e. as occurs extensively during milling of pulses into flour) results in a loss of such properties and also the potential health benefits to consumers.
This knowledge has presented an opportunity to exploit alternative processing techniques for the manufacture of pulse-based ingredients that preserve the desirable low GI of whole pulses. Incorporation of such ingredients has the potential to lower the glycaemic and insulinaemic responses to staple food products and/or may promote satiety, thereby ameliorating the dietary management of T2D and obesity and reducing the risk factors associated with these diseases. Building on new understanding of the conditions required to preserve cellular integrity, we have successfully created a dry powder consisting predominantly of intact cells which still retains low digestibility (>60% resistant starch). This chickpea powder (CPP) was found to be stable under long-term storage, has a neutral taste and aroma, and showed promise as a low GI 'flour-substitute'.
This study will investigate blood sugar, insulin and gut hormone levels (post-prandial glycaemic, insulinaemic and hormone responses) following the consumption of CPP consumed as a drink and incorporated into a food matrix (bread). It is hypothesised that the structure of the CCP will result in a reduced post-prandial glycaemic response, while maintaining (or improving) the insulinaemic and gut hormone responses. This regulation of blood sugar levels following a meal would be beneficial for people with impaired glucose metabolism, such as T2DM. This study will consist of two phases, both utilising a three-arm, random crossover design.
Phase 1 aims to test the glucose response to unmodified CPP (i.e. has not been cooked). This will involve the consumption of the following test drinks containing 50g of available carbohydrate (i.e. starch and/or sugars): (1) Glucose (an oral glucose tolerance test, OGTT); (2) Control chickpea product (no cellular integrity); and (3) the CPP. These test drinks will be consumed in random order on three separate visits. In order to ensure the test carbohydrates remains in solution, all test drinks will be made up in an equivalent volume of 330 ml (bottled water) containing chocolate flavouring. Participants will be required to fast overnight, a capillary blood glucose measurement will be taken at t=0, followed by consumption of the test drink within 5 min. Further capillary blood glucose measurements will be taken at t=10, 20, 30, 45, 60, 90, and 120 min. Additionally, participants will be provided with a Constant Glucose Monitor (CGM) that will be applied to the upper arm 24hrs prior to the first study day. All three study visits will be completed in 12 days (The length of CGM activity). It is hypothesised that the cell wall integrity in the CPP drink will result in a reduced post-prandial glycaemic response compared to the control chickpea product and the OGTT standard.
Outcome measures: The primary outcome of Phase 1 will be the glycaemic response to the consumption of CPP drink compared to both the OGTT and control chickpea product. In vitro studies suggest that maintenance of cellular integrity will reduce the early phase of post-prandial glycaemia, as assessed by the incremental area under the curve (iAUC) iAUC0-60min and maximum blood glucose concentration (Cmax). Secondary measures such as the time to reach maximum blood glucose concentration (Tmax), iAUC0-120min and iAUC60-120min will also be assessed.
Phase 2 aims to test the glucose, insulin and gut hormone response to CPP incorporated into a staple food. This will involve the consumption of wheat-based breads containing 50g of available carbohydrate and either; (1) wheat bread (control) (2) wheat bread with 30% CPP substitution of wheat flour, and (3) wheat bread with 60% CPP substitution of wheat flour. These breads will be consumed as part of a breakfast following an overnight fast on three separate study visits. Post-prandial concentrations of plasma glucose, insulin, glucose-dependent insulinotropic peptide (GIP), glucagon-like peptide 1 (GLP-1), peptide YY (PYY) and C-peptide will be measured; at commencement of meal, t=0, and following consumption at, t=15, 30, 45, 60, 90, 120, 180, and 240 min. Additionally, participants will be provided with a Constant Glucose Monitor (CGM) that will be applied to the upper arm 24hrs prior to each study day.
Outcome measures: The primary outcome of Phase 2 will be iAUC0-60min for plasma glucose concentrations and corresponding plasma insulin/C-peptide responses, demonstrating the ability of cell wall integrity to limit starch digestion, and therefore, the rate of glucose appearance in the blood in the early phase of post-prandial glycaemia. Secondary outcome variables include iAUC0-120min, iAUC0-240min, 30-90 and 90-240, Cmax, Tmax changes from baseline up to 240 min for plasma glucose, insulin, and C-peptide concentrations. For the gut hormones plasma GIP, PYY and GLP-1 concentrations will be assessed using the same outcome variables. Subjective measures of study meals and ad libitum meal palatability will be collected at t=10 min and post lunch, respectively. Subjective measures of mood, satiety and digestive comfort will be collected t=0, 10, 30, 60, 120, 180, 210, 240 min and post lunch. The energy intake from the ad libitum lunch provided following the experimental period will also be compared. Subjective measures will be summarised using descriptive statistics.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
- Model description
- Cross-over design: Each participant will receive a control plus 2 treatments
| Arm | Type | Receives |
|---|---|---|
| Phase 1: Control | Placebo comparator | Dietary Supplement: Chickpea powderoral glucose tolerance test (OGTT): 58g Dextrose in 330ml water |
| Phase1: Chickpea Control | Active comparator | Dietary Supplement: Chickpea powder"sub-cellular" Chickpea powder: 58g total available carbohydrate, provided as 50g from chickpea powder + 8g from chocolate flavouring |
| Phase1: Chickpea Powder | Experimental | Dietary Supplement: Chickpea powderChickpea powder: 58g total available carbohydrate, provided as 50g from chickpea powder + 8g from chocolate flavouring |
| Phase 2: Control | Active comparator | Dietary Supplement: Chickpea powderWheat bread: breakfast consisting of a 100% wheat bread roll containing 54g available carbohydrate + 20g diabetic strawberry jam containing 2g sugar + 360ml water |
| Phase 2: 30%Chickpea Powder | Experimental | Dietary Supplement: Chickpea powderWheat bread: breakfast consisting of a 70% wheat / 30% Chickpea powder bread roll containing 54g available carbohydrate + 20g diabetic strawberry jam containing 2g sugar + 360ml water |
| Phase 2: 60%Chickpea Powder | Experimental | Dietary Supplement: Chickpea powderWheat bread: breakfast consisting of a 40% wheat / 60% Chickpea powder bread roll containing 54g available carbohydrate + 20g diabetic strawberry jam containing 2g sugar + 360ml water |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age: 18-45 y
- Men and women
- Healthy (free of diagnosed diseases listed in the exclusion criteria)
- Body Mass Index 18-35 kg/m2
- Able to understand the information sheet and willing to comply with study protocol
Key exclusion criteria (13 listed)
- Those with known or suspected food allergies (particularly to wheat, as specified in the screening questionnaire and participant information form) or hypersensitivity
- Women who are pregnant, intending to become pregnant, or breastfeeding
- Participation in another clinical trial
- Those who have donated blood within 3 months of the screening visit and participants for whom participation in this study would result in having donated more than 1500 millilitres of blood in the previous 12 months.
- Body mass index <18 or >35 kg/m2
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 |
|---|---|---|
| Chickpea powderChickpea powder is produce using novel production techniques to maintain chickpea cell structure. It will be incorporated into a drink (Dextrose control), or baked into bread rolls at 30% or 60% substitution of wheat flour(100% Wheat flour control). | Dietary supplement | Phase 1: Control, Phase 2: 30%Chickpea Powder, Phase 2: 60%Chickpea Powder, Phase 2: Control, Phase1: Chickpea Control, Phase1: Chickpea Powder |
Primary outcome
Phase 1: Postprandial Glycaemia (iAUC 0-60min)
Time frame: 60 min
The primary endpoint is iAUC 0-60 min for plasma glucose concentrations
Phase 2: Postprandial Glycaemia / Insulinaemia (iAUC 0-60min)
Time frame: 60 min
The primary endpoint is iAUC 0-60 min for plasma glucose, Insulin, c-peptide and Gut hormone concentrations
10 secondary outcomes
Phase 1: Postprandial Glycaemia (iAUC 0-120min)
Time frame: 120 min
Phase 1: Postprandial Glycaemia (iAUC 60-120min)
Time frame: 60 min
Phase 1: Postprandial Glycaemia (Cmax)
Time frame: 120 min
Phase 1: Postprandial Glycaemia (Tmax)
Time frame: 120 min
Phase 2: Postprandial Glycaemia / Insulinaemia (iAUC 0-120min)
Time frame: 120 min
Phase 2: Postprandial Glycaemia / Insulinaemia (iAUC 0-240min)
Time frame: 240 min
Phase 2: Postprandial Glycaemia / Insulinaemia (iAUC 30-90min)
Time frame: 60 min
Phase 2: Postprandial Glycaemia / Insulinaemia (iAUC 90-240min)
Time frame: 150 min
Phase 2: Postprandial Glycaemia / Insulinaemia (Cmax)
Time frame: 240 min
Phase 2: Postprandial Glycaemia / Insulinaemia (Tmax)
Time frame: 240 min
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2020.
- Derived from this study: PubMed 36811474Bajka BH, Pinto AM, Perez-Moral N, Saha S, Ryden P, Ahn-Jarvis J, van der Schoot A, Bland C, Berry SE, Ellis PR, Edwards CH. Enhanced secretion of satiety-promoting gut hormones in healthy humans after consumption of white bread enriched with cellular chickpea flour: A randomized crossover study. Am J Clin Nutr. 2023 Mar;117(3):477-489. doi: 10.1016/j.ajcnut.2022.12.008. Epub 2022 Dec 28.
- Individual participant dataSharing planned: No
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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.
Peter Ellis, PhD principal investigator
King's College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chickpea powder in people with Postprandial Period, run by King's College London at 1 site in United Kingdom.
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 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Phase 1: Postprandial Glycaemia (iAUC 0-60min) (time frame: 60 min). 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 NCT03994276, 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 Sep 2020.