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

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Dietary Supplement: 25 g Nutralys Pea Protein; Dietary Supplement: 50 g Glucose; Dietary Supplement: 50 g Nutralys S85 Plus.

• Registration Number: NCT04610203
• Lead Sponsor: Oxford Brookes University

Brief Summary

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

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

Study Timeline

• Study Start: 2018-12-03
• Primary Completion: 2019-07-05
• Study Completion: 2019-09-30
• Status Verified: 2020-10
• Study First Submitted: 2020-10-10
• Study First Submitted QC: 2020-10-25
• Last Update Submitted: 2020-10-29
• Study First Posted: 2020-10-30
• Last Update Posted: 2020-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Nutralys S85 Plus 25 g	25 g Nutralys Pea Protein	Nutralys S85 Plus Pea Protein 25 g + 50 g Glucose
Glucose	50 g Glucose	Glucose - 50 g
Nutralys S85 Plus 50 g	50 g Nutralys S85 Plus.	Nutralys S85 Plus Pea Protein 50 g + 50 g Glucose

Primary Outcome Measures

Name	Time	Method
Change in blood glucose response from baseline for 3 hours	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
Change in plasma insulin response from baseline for 3 hours	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
Time of blood glucose peak (Tmax)	0-3 hours	Time of blood glucose peak after consumption of the test food
Area under the plasma insulin concentration versus time curve	3 hours	Area under the plasma insulin concentration versus time curve was calculated by trapezoidal rule
Peak blood glucose concentration (Cmax)	0-3 hours	Peak blood glucose concentration (Cmax) after consumption of the test food
Peak plasma insulin concentration (Cmax)	0-3 hours	Peak plasma insulin concentration (Cmax) after consumption of the test food
Time of plasma insulin peak (Tmax)	0-3 hours	Time of plasma insulin peak after consumption of the test food
Area under the blood glucose concentration versus time curve	3 hours	Area under the blood glucose concentration versus time curve was calculated by trapezoidal rule

Secondary Outcome Measures

Name	Time	Method
Area under the plasma GIP concentration versus time curve	3 hours	Area under the plasma GIP concentration versus time curve was calculated by trapezoidal rule
Change in GLP-1 from baseline for 3 hours	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
Change in GIP from baseline for 3 hours	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
Peak plasma GLP-1 concentration (Cmax)	0-3 hours	Peak plasma GLP-1 concentration (Cmax) after consumption of the test food
Peak plasma GIP concentration (Cmax)	0-3 hours	Peak plasma GIP concentration (Cmax) after consumption of the test food
Time of plasma GIP peak (Tmax)	0-3 hours	Time of plasma GIP peak after consumption of the test food
Area under the plasma GLP-1 concentration versus time curve	3 hours	Area under the plasma GLP-1 concentration versus time curve was calculated by trapezoidal rule
Time of plasma GLP-1 peak (Tmax)	0-3 hours	Time of plasma GLP-1 peak after consumption of the test food

Trial Locations

Locations (1)

Oxford Brookes Centre for Nutrition and Health; 🇬🇧 Oxford, United Kingdom