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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Dietary supplement: 50 g Glucose; 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

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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Oxford, United Kingdom, OX3 0BP
    • Oxford Brookes Centre for Nutrition and Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

5

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Oxford Brookes University
• Collaborators: Roquette Freres

Publications and helpful links

General Publications

• Siahanidou T, Margeli A, Kappis A, Papassotiriou I, Mandyla H. Circulating visfatin levels in healthy preterm infants are independently associated with high-density lipoprotein cholesterol levels and dietary long-chain polyunsaturated fatty acids. Metabolism. 2011 Mar;60(3):389-93. doi: 10.1016/j.metabol.2010.03.002. Epub 2010 Mar 31.

Helpful Links

• Food Products-Determination of the glycaemic index (GI) and recommendation for food classification.

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2021
• Primary Completion (Actual): July 13, 2022
• Study Completion (Actual): August 29, 2022

Study Registration Dates

• First Submitted: April 29, 2021
• First Submitted That Met QC Criteria: April 29, 2021
• First Posted (Actual): May 4, 2021

Study Record Updates

• Last Update Posted (Actual): September 7, 2022
• Last Update Submitted That Met QC Criteria: September 5, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: CPS-20-255; WT762123 (Other Identifier: Oxford Brookes University)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No