Clinical trial NCT04610203: Glycaemic Response, Insulinaemic Response, GLP-1 and GIP Testing of Food Product Lines
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: Oxford Brookes University
Sponsor class: OTHER
Collaborators: name: Roquette Freres
First posted: 2020-10-30
Enrollment: 41
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: randomised, repeat measure, crossover design trial
Primary purpose: BASIC_SCIENCE

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

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:
measure: Change in GLP-1 from baseline for 3 hours
timeFrame: 3 hours
measure: Change in GIP from baseline for 3 hours
timeFrame: 3 hours
measure: Area under the plasma GLP-1 concentration versus time curve
timeFrame: 3 hours
measure: Area under the plasma GIP concentration versus time curve
timeFrame: 3 hours
measure: Peak plasma GLP-1 concentration (Cmax)
timeFrame: 0-3 hours
measure: Peak plasma GIP concentration (Cmax)
timeFrame: 0-3 hours
measure: Time of plasma GLP-1 peak (Tmax)
timeFrame: 0-3 hours
measure: Time of plasma GIP peak (Tmax)
timeFrame: 0-3 hours
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.