Glycaemic Response, Insulinaemic Response, GLP-1 and GIP Testing of Food Product Lines

Study Overview
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Brief Summary
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The aim of this study was to compare the glycaemic response, insulinaemic response, GIP response and GLP-1 response to glucose, 25 g Nutralys S85 Plus and 50 g Nutralys S85 Plus using a single-blind, randomised, repeat measure, crossover design trial.

Detailed Description
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The aims of this study were to examine: Phase I - the glycaemic response (GR) and insulinaemic response (IR) to: 50 g available carbohydrate 50 g available carbohydrate + protein (dose 1) 50 g available carbohydrate + protein (dose 2) Phase II - the GLP-1 and GIP response to: 50 g available carbohydrate 50 g available carbohydrate + protein (dose 1) 50 g available carbohydrate + protein (dose 2) A single-blind, randomised, repeat measure, crossover design trial was used to study the response following consumption of three meals: one reference meal (50 g available carbohydrate) and two test meals (50 g available carbohydrate with protein dose 1 and 50 g available carbohydrate with protein dose 2). The study was conducted in two phases: Phase I: glycaemic response (GR), insulinaemic response (IR) Phase II: GLP-1 response and GIP response

Official Title
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Glycaemic, Insulinaemic, Gastric Inhibitory Polypeptide (GIP) and Glucagon-like Peptide-1 (GLP-1) Response for Glucose, Glucose With 25 g Nutralys S85 Plus and Glucose With 50 g Nutralys S85 Plus

Conditions
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Healthy

Intervention / Treatment
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* Dietary Supplement: 25 g Nutralys Pea Protein
* Dietary Supplement: 50 g Nutralys S85 Plus.
* Dietary Supplement: 50 g Glucose


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 18 to 60 years Body mass index (BMI) less than 30kg/m2 Exclusion Criteria: Pregnant or lactating Fasting blood glucose value > 6.1 mmol/l Any known food allergy or intolerance Medical condition(s) or medication(s) known to affect glucose regulation or appetite and/or which influence digestion and absorption of nutrients Known history of diabetes mellitus or the use of antihyperglycaemic drugs or insulin to treat diabetes and related conditions Major medical or surgical event requiring hospitalization within the preceding 3 months Use of steroids, protease inhibitors or antipsychotics (all of which have major effects on glucose metabolism and body fat distribution). Unable to comply with experimental procedures or did not follow GR testing safety guidelines.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: randomised, repeat measure, crossover design trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Glucose<br>Glucose - 50 g | Dietary Supplement: 50 g Glucose<br>* To determine the glycaemic response, insulinaemic response, GIP response and GLP-1 response to 50g Glucose<br>|
| Experimental: Nutralys S85 Plus 25 g<br>Nutralys S85 Plus Pea Protein 25 g + 50 g Glucose | Dietary Supplement: 25 g Nutralys Pea Protein<br>* To determine the glycaemic response, insulinaemic response, GIP response and GLP-1 response to 50g Glucose +25g Nutralys S85 Plus<br>|
| Experimental: Nutralys S85 Plus 50 g<br>Nutralys S85 Plus Pea Protein 50 g + 50 g Glucose | Dietary Supplement: 50 g Nutralys S85 Plus.<br>* To determine the glycaemic response, insulinaemic response, GIP response and GLP-1 response to 50g Glucose+50 g Nutralys S85 Plus .<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in blood glucose response from baseline for 3 hours | Change in postprandial blood glucose response from baseline was measured at 15 min, 30 min, 45 min, 1 hour, 1.5 hours, 2 hours, 2.5 hours and 3 hours | 3 hours | 
| Change in plasma insulin response from baseline for 3 hours | Change in postprandial plasma insulin response from baseline was measured at 15 min, 30 min, 45 min, 1 hour, 1.5 hours, 2 hours, 2.5 hours and 3 hours | 3 hours | 
| Area under the blood glucose concentration versus time curve | Area under the blood glucose concentration versus time curve was calculated by trapezoidal rule | 3 hours | 
| Area under the plasma insulin concentration versus time curve | Area under the plasma insulin concentration versus time curve was calculated by trapezoidal rule | 3 hours | 
| Peak blood glucose concentration (Cmax) | Peak blood glucose concentration (Cmax) after consumption of the test food | 0-3 hours | 
| Peak plasma insulin concentration (Cmax) | Peak plasma insulin concentration (Cmax) after consumption of the test food | 0-3 hours | 
| Time of blood glucose peak (Tmax) | Time of blood glucose peak after consumption of the test food | 0-3 hours | 
| Time of plasma insulin peak (Tmax) | Time of plasma insulin peak after consumption of the test food | 0-3 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in GLP-1 from baseline for 3 hours | Change in GLP-1 from baseline was measured at 15 min, 30 min, 45 min, 1 hour, 1.5 hours, 2 hours, 2.5 hours and 3 hours | 3 hours | 
| Change in GIP from baseline for 3 hours | Change in GIP from baseline was measured at 15 min, 30 min, 45 min, 1 hour, 1.5 hours, 2 hours, 2.5 hours and 3 hours | 3 hours | 
| Area under the plasma GLP-1 concentration versus time curve | Area under the plasma GLP-1 concentration versus time curve was calculated by trapezoidal rule | 3 hours | 
| Area under the plasma GIP concentration versus time curve | Area under the plasma GIP concentration versus time curve was calculated by trapezoidal rule | 3 hours | 
| Peak plasma GLP-1 concentration (Cmax) | Peak plasma GLP-1 concentration (Cmax) after consumption of the test food | 0-3 hours | 
| Peak plasma GIP concentration (Cmax) | Peak plasma GIP concentration (Cmax) after consumption of the test food | 0-3 hours | 
| Time of plasma GLP-1 peak (Tmax) | Time of plasma GLP-1 peak after consumption of the test food | 0-3 hours | 
| Time of plasma GIP peak (Tmax) | Time of plasma GIP peak after consumption of the test food | 0-3 hours |