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

Oxford Brookes University

Status: Completed

Conditions: Healthy

Treatments: Dietary Supplement: 50 g Glucose; Dietary Supplement: 25 g Nutralys Pea Protein; Dietary Supplement: 50 g Nutralys S85 Plus.

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04610203

pfact 9806 (Other Identifier)

CPS 18-439

Details and patient eligibility

About

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.

Full 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

Enrollment: 41 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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41 participants in 3 patient groups, including a placebo group

Glucose

Placebo Comparator group

Description:

Glucose - 50 g

Treatment:

Dietary Supplement: 50 g Glucose

Nutralys S85 Plus 25 g

Experimental group

Description:

Nutralys S85 Plus Pea Protein 25 g + 50 g Glucose

Treatment:

Dietary Supplement: 25 g Nutralys Pea Protein

Nutralys S85 Plus 50 g

Experimental group

Description:

Nutralys S85 Plus Pea Protein 50 g + 50 g Glucose

Treatment:

Dietary Supplement: 50 g Nutralys S85 Plus.