Glycaemic Response and Insulinaemic Response for Nutralys S85 Plus and Whey Protein

Study Overview
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Brief Summary
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A comparison of the glycaemic response and insulinaemic response to glucose, Nutralys S85 Plus pea protein and whey protein using a single-blind, randomised, repeat measure, crossover design trial.

Detailed Description
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A single-blind, randomised, repeat measure, crossover design trial will be used to study the glycaemic response and insulinaemic response following consumption of five products: one reference product (50 g available carbohydrate Glucose) and four test products (50 g available carbohydrate Glucose with 10 g NUTRALYS®S85 Plus pea protein, 50 g available carbohydrate Glucose with 20 g NUTRALYS®S85 Plus pea protein, 50 g available carbohydrate Glucose with 10 g Whey protein concentrate and 50 g available carbohydrate Glucose with 20 g Whey protein concentrate).

Official Title
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Glycaemic Response and Insulinaemic Response for Nutralys S85 Plus and Whey Protein

Conditions
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Healthy

Intervention / Treatment
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* Dietary Supplement: 10 g NUTRALYS®S85 Plus pea protein
* Dietary Supplement: 20 g NUTRALYS®S85 Plus pea protein
* Dietary Supplement: 10 g Whey protein concentrate
* Dietary Supplement: 20 g Whey protein concentrate
* 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: single-blind, randomised, repeat measure, crossover design trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Glucose<br>Glucose 50 g available carbohydrate | Dietary Supplement: 50 g Glucose<br>* To determine the glycaemic response and insulinaemic response to 50g Glucose<br>|
| Experimental: 10 g NUTRALYS®S85 Plus pea protein<br>50 g available carbohydrate Glucose + 10 g NUTRALYS®S85 Plus pea protein | Dietary Supplement: 10 g NUTRALYS®S85 Plus pea protein<br>* To determine the glycaemic response and insulinaemic response to 50g Glucose + 10 g NUTRALYS®S85 Plus pea protein.<br>|
| Experimental: 20 g NUTRALYS®S85 Plus pea protein<br>50 g available carbohydrate Glucose + 20 g NUTRALYS®S85 Plus pea protein | Dietary Supplement: 20 g NUTRALYS®S85 Plus pea protein<br>* To determine the glycaemic response and insulinaemic response to 50g Glucose + 20 g NUTRALYS®S85 Plus pea protein.<br>|
| Experimental: 10 g Whey protein concentrate<br>50 g available carbohydrate Glucose + 10 g Whey protein concentrate | Dietary Supplement: 10 g Whey protein concentrate<br>* To determine the glycaemic response and insulinaemic response to 50g Glucose + 10 g Whey protein concentrate.<br>|
| Experimental: 20 g Whey protein concentrate<br>50 g available carbohydrate Glucose + 20 g Whey protein concentrate | Dietary Supplement: 20 g Whey protein concentrate<br>* To determine the glycaemic response and insulinaemic response to 50g Glucose + 20 g Whey protein concentrate.<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 |