Postprandial Period Clinical Trial
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).
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.
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