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CompletedNCT04610203Updated Nov 2, 2020

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

An interventional study of 25 g Nutralys Pea Protein and 50 g Nutralys S85 Plus. in Healthy, sponsored by Oxford Brookes University. Completed at 1 site in United Kingdom. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-11-02.

Sponsored by Oxford Brookes University · Not applicable, Interventional, and Basic science

From the registry’s dates

  • Registered 1 year 10 months after the study started (first participant enrolled Dec 2018, registered Oct 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
41
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study 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.

Read the 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
02

Conditions studied

  • Healthy
03

In context

Lead sponsor

Oxford Brookes University is the lead sponsor of 32 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Aged 18 to 60 years
  • Body mass index (BMI) less than 30kg/m2

Exclusion criteria

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.
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Participant)
Enrollment
41 participants (actual)

Study arms

  • Placebo comparator
    Glucose

    Glucose - 50 g

    Dietary Supplement: 50 g Glucose

  • Experimental
    Nutralys S85 Plus 25 g

    Nutralys S85 Plus Pea Protein 25 g + 50 g Glucose

    Dietary Supplement: 25 g Nutralys Pea Protein

  • Experimental
    Nutralys S85 Plus 50 g

    Nutralys S85 Plus Pea Protein 50 g + 50 g Glucose

    Dietary Supplement: 50 g Nutralys S85 Plus.

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

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 3 hours

  2. 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

    Time frame: 3 hours

  3. Area under the blood glucose concentration versus time curve

    Area under the blood glucose concentration versus time curve was calculated by trapezoidal rule

    Time frame: 3 hours

  4. Area under the plasma insulin concentration versus time curve

    Area under the plasma insulin concentration versus time curve was calculated by trapezoidal rule

    Time frame: 3 hours

  5. Peak blood glucose concentration (Cmax)

    Peak blood glucose concentration (Cmax) after consumption of the test food

    Time frame: 0-3 hours

  6. Peak plasma insulin concentration (Cmax)

    Peak plasma insulin concentration (Cmax) after consumption of the test food

    Time frame: 0-3 hours

  7. Time of blood glucose peak (Tmax)

    Time of blood glucose peak after consumption of the test food

    Time frame: 0-3 hours

  8. Time of plasma insulin peak (Tmax)

    Time of plasma insulin peak after consumption of the test food

    Time frame: 0-3 hours

Secondary outcomes

  1. 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

    Time frame: 3 hours

  2. 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

    Time frame: 3 hours

  3. 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

    Time frame: 3 hours

  4. Area under the plasma GIP concentration versus time curve

    Area under the plasma GIP concentration versus time curve was calculated by trapezoidal rule

    Time frame: 3 hours

  5. Peak plasma GLP-1 concentration (Cmax)

    Peak plasma GLP-1 concentration (Cmax) after consumption of the test food

    Time frame: 0-3 hours

  6. Peak plasma GIP concentration (Cmax)

    Peak plasma GIP concentration (Cmax) after consumption of the test food

    Time frame: 0-3 hours

  7. Time of plasma GLP-1 peak (Tmax)

    Time of plasma GLP-1 peak after consumption of the test food

    Time frame: 0-3 hours

  8. Time of plasma GIP peak (Tmax)

    Time of plasma GIP peak after consumption of the test food

    Time frame: 0-3 hours

07

Study locations

1 site
  • Oxford Brookes Centre for Nutrition and Health
    Oxford, OX3 0BP, United Kingdom
08

References and documents

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. PubMed 20359723 ↗

Study documents

  • Protocol and statistical analysis plan · Oct 25, 2018
  • Informed consent form · Nov 27, 2018

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 2, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04610203
Lead sponsor
Oxford Brookes University
Collaborators
Roquette Freres
Responsible party
Dr. Sangeetha Thondre (Principal Investigator, Oxford Brookes University) — Principal investigator
First posted
Oct 30, 2020
Start date
Dec 3, 2018
Primary completion
Jul 5, 2019
Completion
Sep 30, 2019
Last update
Nov 2, 2020

Study contacts

Sangeetha Thondre, PhD
principal investigator · Oxford Brookes University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.

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