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

NCT04871971 — Not applicable, Completed, 30 participants, Oxford Brookes University

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RegistryNCT04871971
StatusCompleted
PhaseNot applicable
Study typeInterventional; randomized, crossover, masking: single, basic science
Enrollment30 (Actual)
SponsorOxford Brookes University (Other); collaborators: Roquette Freres
ConditionsHealthy
Interventions10 g NUTRALYS®S85 Plus pea protein, 20 g NUTRALYS®S85 Plus pea protein, 10 g Whey protein concentrate, 20 g Whey protein concentrate, 50 g Glucose (Dietary supplement)
Datesstart 2021-09-15, primary completion 2022-07-13, completion 2022-08-29, first posted 2021-05-04, last updated 2022-09-07
Locations1 site in United Kingdom

Related Papers Related Patents Related Grants Related Experts
All trials for Healthy All trials of 10 g NUTRALYS®S85 Plus pea protein All trials of 20 g NUTRALYS®S85 Plus pea protein

-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.

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+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).

+Arms and interventions

ArmTypeInterventionsDescription
GlucosePlacebo comparatorDietary Supplement: 50 g GlucoseGlucose 50 g available carbohydrate
10 g NUTRALYS®S85 Plus pea proteinExperimentalDietary Supplement: 10 g NUTRALYS®S85 Plus pea protein50 g available carbohydrate Glucose + 10 g NUTRALYS®S85 Plus pea protein
20 g NUTRALYS®S85 Plus pea proteinExperimentalDietary Supplement: 20 g NUTRALYS®S85 Plus pea protein50 g available carbohydrate Glucose + 20 g NUTRALYS®S85 Plus pea protein
10 g Whey protein concentrateExperimentalDietary Supplement: 10 g Whey protein concentrate50 g available carbohydrate Glucose + 10 g Whey protein concentrate
20 g Whey protein concentrateExperimentalDietary Supplement: 20 g Whey protein concentrate50 g available carbohydrate Glucose + 20 g Whey protein concentrate
  • 10 g NUTRALYS®S85 Plus pea protein (Dietary supplement): 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 (Dietary supplement): To determine the glycaemic response and insulinaemic response to 50g Glucose + 20 g NUTRALYS®S85 Plus pea protein.
  • 10 g Whey protein concentrate (Dietary supplement): To determine the glycaemic response and insulinaemic response to 50g Glucose + 10 g Whey protein concentrate.
  • 20 g Whey protein concentrate (Dietary supplement): To determine the glycaemic response and insulinaemic response to 50g Glucose + 20 g Whey protein concentrate.
  • 50 g Glucose (Dietary supplement): To determine the glycaemic response and insulinaemic response to 50g Glucose

+Outcome measures

Primary outcomes

  • 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
  • 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
  • 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 blood glucose peak (Tmax) [0-3 hours]: Time of blood glucose peak 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

+Eligibility

Sex: All, ages: 18 Years to 60 Years, accepts healthy volunteers

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.

+Locations (1)

FacilityCityCountryStatus
Oxford Brookes Centre for Nutrition and HealthOxfordUnited Kingdom

+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. PMID 20359723

+Study documents

+Investigators