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Completed

NCT Number: NCT04871971

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.

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Key information

Conditions

Healthy

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oxford Brookes Centre for Nutrition and Health

Oxford, OX3 0BP, United Kingdom

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. Change in blood glucose response from baseline for 3 hours

    Time frame: 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

  2. Change in plasma insulin response from baseline for 3 hours

    Time frame: 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. Area under the blood glucose concentration versus time curve

    Time frame: 3 hours

    Area under the blood glucose concentration versus time curve was calculated by trapezoidal rule

  4. Area under the plasma insulin concentration versus time curve

    Time frame: 3 hours

    Area under the plasma insulin concentration versus time curve was calculated by trapezoidal rule

  5. Peak blood glucose concentration (Cmax)

    Time frame: 0-3 hours

    Peak blood glucose concentration (Cmax) after consumption of the test food

  6. Peak plasma insulin concentration (Cmax)

    Time frame: 0-3 hours

    Peak plasma insulin concentration (Cmax) after consumption of the test food

  7. Time of blood glucose peak (Tmax)

    Time frame: 0-3 hours

    Time of blood glucose peak after consumption of the test food

  8. Time of plasma insulin peak (Tmax)

    Time frame: 0-3 hours

    Time of plasma insulin peak after consumption of the test food

Sponsors and collaborators

Lead sponsor

Oxford Brookes University

Other

Collaborators

  • Roquette Freres

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
May 4, 2021
Registry last updated
Sep 7, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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