Clinical trial NCT04871971: Glycaemic Response and Insulinaemic Response for Nutralys S85 Plus and Whey Protein
Official title: Glycaemic Response and Insulinaemic Response for Nutralys S85 Plus and Whey Protein
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: Oxford Brookes University
Sponsor class: OTHER
Collaborators: name: Roquette Freres
First posted: 2021-05-04
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: single-blind, randomised, repeat measure, crossover design trial
Primary purpose: BASIC_SCIENCE

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Change in blood glucose response from baseline for 3 hours
timeFrame: 3 hours
measure: Change in plasma insulin response from baseline for 3 hours
timeFrame: 3 hours
measure: Area under the blood glucose concentration versus time curve
timeFrame: 3 hours
measure: Area under the plasma insulin concentration versus time curve
timeFrame: 3 hours
measure: Peak blood glucose concentration (Cmax)
timeFrame: 0-3 hours
measure: Peak plasma insulin concentration (Cmax)
timeFrame: 0-3 hours
measure: Time of blood glucose peak (Tmax)
timeFrame: 0-3 hours
measure: Time of plasma insulin peak (Tmax)
timeFrame: 0-3 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Oxford
country: United Kingdom
facility: Oxford Brookes Centre for Nutrition and Health
Study officials:
affiliation: Oxford Brookes University
name: Sangeetha Thondre, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.