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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04610203
• Other study ID #: CPS 18-439
• Secondary ID: pfact 9806
• Status: Completed
• Phase: N/A
• Start date: December 3, 2018
• Est. completion date: September 30, 2019

Study information

• Verified date: October 2020
• Source: Oxford Brookes University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: September 30, 2019
• Est. primary completion date: July 5, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

Dietary Supplement:
• 25 g Nutralys Pea Protein
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.
To determine the glycaemic response, insulinaemic response, GIP response and GLP-1 response to 50g Glucose+50 g Nutralys S85 Plus .
• 50 g Glucose
To determine the glycaemic response, insulinaemic response, GIP response and GLP-1 response to 50g Glucose

Locations

Country	Name	City	State
United Kingdom	Oxford Brookes Centre for Nutrition and Health	Oxford

Sponsors (2)

Lead Sponsor	Collaborator
Oxford Brookes University	Roquette Freres

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in blood glucose response from baseline for 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	3 hours
Primary	Change in plasma insulin response from baseline for 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 hours
Primary	Area under the blood glucose concentration versus time curve	Area under the blood glucose concentration versus time curve was calculated by trapezoidal rule	3 hours
Primary	Area under the plasma insulin concentration versus time curve	Area under the plasma insulin concentration versus time curve was calculated by trapezoidal rule	3 hours
Primary	Peak blood glucose concentration (Cmax)	Peak blood glucose concentration (Cmax) after consumption of the test food	0-3 hours
Primary	Peak plasma insulin concentration (Cmax)	Peak plasma insulin concentration (Cmax) after consumption of the test food	0-3 hours
Primary	Time of blood glucose peak (Tmax)	Time of blood glucose peak after consumption of the test food	0-3 hours
Primary	Time of plasma insulin peak (Tmax)	Time of plasma insulin peak after consumption of the test food	0-3 hours
Secondary	Change in GLP-1 from baseline for 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	3 hours
Secondary	Change in GIP from baseline for 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 hours
Secondary	Area under the plasma GLP-1 concentration versus time curve	Area under the plasma GLP-1 concentration versus time curve was calculated by trapezoidal rule	3 hours
Secondary	Area under the plasma GIP concentration versus time curve	Area under the plasma GIP concentration versus time curve was calculated by trapezoidal rule	3 hours
Secondary	Peak plasma GLP-1 concentration (Cmax)	Peak plasma GLP-1 concentration (Cmax) after consumption of the test food	0-3 hours
Secondary	Peak plasma GIP concentration (Cmax)	Peak plasma GIP concentration (Cmax) after consumption of the test food	0-3 hours
Secondary	Time of plasma GLP-1 peak (Tmax)	Time of plasma GLP-1 peak after consumption of the test food	0-3 hours
Secondary	Time of plasma GIP peak (Tmax)	Time of plasma GIP peak after consumption of the test food	0-3 hours

External Links

•   23. Food Products-Determination of the glycaemic index (GI) and recommendation for food classification.