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Completed

NCT Number: NCT04610203

Glycaemic Response, Insulinaemic Response, GLP-1 and GIP Testing of Food Product Lines

The aim of this study was to compare the glycaemic response, insulinaemic response, GIP response and GLP-1 response to glucose, 25 g Nutralys S85 Plus and 50 g Nutralys S85 Plus using a single-blind, randomised, repeat measure, crossover design trial.

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Key information

Conditions

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

The aims of this study were to examine:

  • Phase I - the glycaemic response (GR) and insulinaemic response (IR) to:
  • 50 g available carbohydrate
  • 50 g available carbohydrate + protein (dose 1)
  • 50 g available carbohydrate + protein (dose 2)
  • Phase II - the GLP-1 and GIP response to:
  • 50 g available carbohydrate
  • 50 g available carbohydrate + protein (dose 1)
  • 50 g available carbohydrate + protein (dose 2)

A single-blind, randomised, repeat measure, crossover design trial was used to study the response following consumption of three meals: one reference meal (50 g available carbohydrate) and two test meals (50 g available carbohydrate with protein dose 1 and 50 g available carbohydrate with protein dose 2). The study was conducted in two phases:

  • Phase I: glycaemic response (GR), insulinaemic response (IR)
  • Phase II: GLP-1 response and GIP response

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

25 g Nutralys Pea Protein

Dietary Supplement

To determine the glycaemic response, insulinaemic response, GIP response and GLP-1 response to 50g Glucose +25g Nutralys S85 Plus

50 g Nutralys S85 Plus.

Dietary Supplement

To determine the glycaemic response, insulinaemic response, GIP response and GLP-1 response to 50g Glucose+50 g Nutralys S85 Plus .

50 g Glucose

Dietary Supplement

To determine the glycaemic response, insulinaemic response, GIP response and GLP-1 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

Secondary outcomes

  1. Change in GLP-1 from baseline for 3 hours

    Time frame: 3 hours

    Change in GLP-1 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 GIP from baseline for 3 hours

    Time frame: 3 hours

    Change in GIP 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 plasma GLP-1 concentration versus time curve

    Time frame: 3 hours

    Area under the plasma GLP-1 concentration versus time curve was calculated by trapezoidal rule

  4. Area under the plasma GIP concentration versus time curve

    Time frame: 3 hours

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

  5. Peak plasma GLP-1 concentration (Cmax)

    Time frame: 0-3 hours

    Peak plasma GLP-1 concentration (Cmax) after consumption of the test food

  6. Peak plasma GIP concentration (Cmax)

    Time frame: 0-3 hours

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

  7. Time of plasma GLP-1 peak (Tmax)

    Time frame: 0-3 hours

    Time of plasma GLP-1 peak after consumption of the test food

  8. Time of plasma GIP peak (Tmax)

    Time frame: 0-3 hours

    Time of plasma GIP peak after consumption of the test food

Sponsors and collaborators

Lead sponsor

Oxford Brookes University

Other

Collaborators

  • Roquette Freres

Registry information

Official study title

Glycaemic, Insulinaemic, Gastric Inhibitory Polypeptide (GIP) and Glucagon-like Peptide-1 (GLP-1) Response for Glucose, Glucose With 25 g Nutralys S85 Plus and Glucose With 50 g Nutralys S85 Plus

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Oct 30, 2020
Registry last updated
Nov 2, 2020

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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