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

Not Applicable

Completed

• Conditions: Healthy

• Registration Number: NCT04871971
• Lead Sponsor: Oxford Brookes University

Brief Summary

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

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).

Study Timeline

• Study First Submitted: 2021-04-29
• Study First Submitted QC: 2021-04-29
• Study First Posted: 2021-05-04
• Study Start: 2021-09-15
• Primary Completion: 2022-07-13
• Study Completion: 2022-08-29
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-05
• Last Update Posted: 2022-09-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Primary Outcome Measures

Name	Time	Method
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 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
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
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
Peak plasma insulin concentration (Cmax)	0-3 hours	Peak plasma insulin concentration (Cmax) after consumption of the test food
Time of blood glucose peak (Tmax)	0-3 hours	Time of blood glucose peak after consumption of the test food
Peak blood glucose concentration (Cmax)	0-3 hours	Peak blood glucose concentration (Cmax) after consumption of the test food

Trial Locations

Locations (1)

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