AzTrials
AzTrials

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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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

Other trials in United Kingdom

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.

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 groups in NCT03994276
Study groupRoleWhat they receive
Phase 1: ControlPlacebo comparatororal glucose tolerance test (OGTT): 58g Dextrose in 330ml water
Receives: Dietary Supplement: Chickpea powder
Phase1: Chickpea ControlActive 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 PowderExperimentalChickpea powder: 58g total available carbohydrate, provided as 50g from chickpea powder + 8g from chocolate flavouring
Receives: Dietary Supplement: Chickpea powder
Phase 2: ControlActive comparatorWheat 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 PowderExperimentalWheat 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 PowderExperimentalWheat 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.

  1. Phase 1: Postprandial Glycaemia (iAUC 0-60min)

    The primary endpoint is iAUC 0-60 min for plasma glucose concentrations

    Measured: 60 min

  2. 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)
  1. Phase 1: Postprandial Glycaemia (iAUC 0-120min)

    iAUC 0-120 min for plasma glucose concentrations

    Measured: 120 min

  2. Phase 1: Postprandial Glycaemia (iAUC 60-120min)

    iAUC 60-120 min for plasma glucose concentrations

    Measured: 60 min

  3. Phase 1: Postprandial Glycaemia (Cmax)

    Cmax for plasma glucose concentrations

    Measured: 120 min

  4. Phase 1: Postprandial Glycaemia (Tmax)

    Tmax for plasma glucose concentrations

    Measured: 120 min

  5. 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

  6. 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

  7. 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

  8. 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

  9. Phase 2: Postprandial Glycaemia / Insulinaemia (Cmax)

    Cmax for plasma glucose, Insulin, c-peptide and Gut hormone concentrations

    Measured: 240 min

  10. 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.

  1. First posted21 Jun 2019
  2. Study start25 Jun 2019
  3. Primary completion10 Feb 2020
  4. Study completion20 May 2020

Resources

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)
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

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.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in