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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04871971
• Other study ID #: CPS-20-255
• Secondary ID: WT762123
• Status: Completed
• Phase: N/A
• Start date: September 15, 2021
• Est. completion date: August 29, 2022

Study information

• Verified date: September 2022
• Source: Oxford Brookes University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 29, 2022
• Est. primary completion date: July 13, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

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.
• 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.
• 10 g Whey protein concentrate
To determine the glycaemic response and insulinaemic response to 50g Glucose + 10 g Whey protein concentrate.
• 20 g Whey protein concentrate
To determine the glycaemic response and insulinaemic response to 50g Glucose + 20 g Whey protein concentrate.
• 50 g Glucose
To determine the glycaemic response and insulinaemic response to 50g Glucose

Locations

Country	Name	City	State
United Kingdom	Oxford Brookes Centre for Nutrition and Health	Oxford

Sponsors (2)

Lead Sponsor	Collaborator
Oxford Brookes University	Roquette Freres

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Peak blood glucose concentration (Cmax)	Peak blood glucose concentration (Cmax) after consumption of the test food	0-3 hours
Primary	Peak plasma insulin concentration (Cmax)	Peak plasma insulin concentration (Cmax) after consumption of the test food	0-3 hours
Primary	Time of blood glucose peak (Tmax)	Time of blood glucose peak after consumption of the test food	0-3 hours
Primary	Time of plasma insulin peak (Tmax)	Time of plasma insulin peak after consumption of the test food	0-3 hours

External Links

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