Healthy
Conditions
Brief summary
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.
Detailed description
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
Interventions
DIETARY_SUPPLEMENT25 g Nutralys Pea Protein
To determine the glycaemic response, insulinaemic response, GIP response and GLP-1 response to 50g Glucose +25g Nutralys S85 Plus
DIETARY_SUPPLEMENT50 g Nutralys S85 Plus.
To determine the glycaemic response, insulinaemic response, GIP response and GLP-1 response to 50g Glucose+50 g Nutralys S85 Plus .
DIETARY_SUPPLEMENT50 g Glucose
To determine the glycaemic response, insulinaemic response, GIP response and GLP-1 response to 50g Glucose
Sponsors
Roquette Freres
Oxford Brookes University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)
Masking description
single-blind
Intervention model description
randomised, repeat measure, crossover design trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time of plasma insulin peak (Tmax) | 0-3 hours | Time of plasma insulin peak after consumption of the test food |
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in GLP-1 from baseline for 3 hours | 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 |
| Change in GIP from baseline for 3 hours | 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 |
| Area under the plasma GLP-1 concentration versus time curve | 3 hours | Area under the plasma GLP-1 concentration versus time curve was calculated by trapezoidal rule |
| Area under the plasma GIP concentration versus time curve | 3 hours | Area under the plasma GIP concentration versus time curve was calculated by trapezoidal rule |
| Peak plasma GLP-1 concentration (Cmax) | 0-3 hours | Peak plasma GLP-1 concentration (Cmax) after consumption of the test food |
| Peak plasma GIP concentration (Cmax) | 0-3 hours | Peak plasma GIP concentration (Cmax) after consumption of the test food |
| Time of plasma GLP-1 peak (Tmax) | 0-3 hours | Time of plasma GLP-1 peak after consumption of the test food |
| Time of plasma GIP peak (Tmax) | 0-3 hours | Time of plasma GIP peak after consumption of the test food |
Countries
United Kingdom
Outcome results
None listed