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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Dietary supplement: 50 g Glucose; Dietary supplement: 25 g Nutralys Pea Protein; Dietary supplement: 50 g Nutralys S85 Plus.

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

• Study Type: Interventional
• Enrollment (Actual): 41
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Oxford, United Kingdom, OX3 0BP
    • Oxford Brookes Centre for Nutrition and Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: SINGLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Glucose; Glucose - 50 g	Dietary supplement: 50 g Glucose; To determine the glycaemic response, insulinaemic response, GIP response and GLP-1 response to 50g Glucose
EXPERIMENTAL: Nutralys S85 Plus 25 g; Nutralys S85 Plus Pea Protein 25 g + 50 g Glucose	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
EXPERIMENTAL: Nutralys S85 Plus 50 g; Nutralys S85 Plus Pea Protein 50 g + 50 g Glucose	Dietary supplement: 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 .

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
Peak blood glucose concentration (Cmax)	Peak blood glucose concentration (Cmax) after consumption of the test food	0-3 hours
Peak plasma insulin concentration (Cmax)	Peak plasma insulin concentration (Cmax) after consumption of the test food	0-3 hours
Time of blood glucose peak (Tmax)	Time of blood glucose peak after consumption of the test food	0-3 hours
Time of plasma insulin peak (Tmax)	Time of plasma insulin peak after consumption of the test food	0-3 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
Peak plasma GLP-1 concentration (Cmax)	Peak plasma GLP-1 concentration (Cmax) after consumption of the test food	0-3 hours
Peak plasma GIP concentration (Cmax)	Peak plasma GIP concentration (Cmax) after consumption of the test food	0-3 hours
Time of plasma GLP-1 peak (Tmax)	Time of plasma GLP-1 peak after consumption of the test food	0-3 hours
Time of plasma GIP peak (Tmax)	Time of plasma GIP peak after consumption of the test food	0-3 hours

Collaborators and Investigators

• Sponsor: Oxford Brookes University
• Collaborators: Roquette Freres

Publications and helpful links

General Publications

• 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.

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 3, 2018
• Primary Completion (ACTUAL): July 5, 2019
• Study Completion (ACTUAL): September 30, 2019

Study Registration Dates

• First Submitted: October 10, 2020
• First Submitted That Met QC Criteria: October 25, 2020
• First Posted (ACTUAL): October 30, 2020

Study Record Updates

• Last Update Posted (ACTUAL): November 2, 2020
• Last Update Submitted That Met QC Criteria: October 29, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: CPS 18-439; pfact 9806 (OTHER: Oxford Brookes University)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Study Data/Documents

1. Study Protocol
2. Informed Consent Form
3. Clinical Study Report
4. Individual Participant Data Set
5. Statistical Analysis Plan
   Information comments: Included in the Study Protocol and Clinical Study report

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No