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

NCT ID: NCT04610203

Last Updated: 2020-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-03

Study Completion Date

2019-09-30

Brief Summary

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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

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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

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

randomised, repeat measure, crossover design trial
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants
single-blind

Study Groups

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Glucose

Glucose - 50 g

Group Type PLACEBO_COMPARATOR

50 g Glucose

Intervention Type DIETARY_SUPPLEMENT

To determine the glycaemic response, insulinaemic response, GIP response and GLP-1 response to 50g Glucose

Nutralys S85 Plus 25 g

Nutralys S85 Plus Pea Protein 25 g + 50 g Glucose

Group Type EXPERIMENTAL

25 g Nutralys Pea Protein

Intervention Type DIETARY_SUPPLEMENT

To determine the glycaemic response, insulinaemic response, GIP response and GLP-1 response to 50g Glucose +25g Nutralys S85 Plus

Nutralys S85 Plus 50 g

Nutralys S85 Plus Pea Protein 50 g + 50 g Glucose

Group Type EXPERIMENTAL

50 g Nutralys S85 Plus.

Intervention Type DIETARY_SUPPLEMENT

To determine the glycaemic response, insulinaemic response, GIP response and GLP-1 response to 50g Glucose+50 g Nutralys S85 Plus .

Interventions

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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

Intervention Type 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 .

Intervention Type DIETARY_SUPPLEMENT

50 g Glucose

To determine the glycaemic response, insulinaemic response, GIP response and GLP-1 response to 50g Glucose

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Roquette Freres

INDUSTRY

Sponsor Role collaborator

Oxford Brookes University

OTHER

Sponsor Role lead

Responsible Party

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Dr. Sangeetha Thondre

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sangeetha Thondre, PhD

Role: PRINCIPAL_INVESTIGATOR

Oxford Brookes University

Locations

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Oxford Brookes Centre for Nutrition and Health

Oxford, , United Kingdom

Site Status

Countries

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United Kingdom

References

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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.

Reference Type BACKGROUND
PMID: 20359723 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Study Documents

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Document Type: Study Protocol

View Document

Document Type: Informed Consent Form

View Document

Document Type: Clinical Study Report

View Document

Document Type: Individual Participant Data Set

View Document

Document Type: Statistical Analysis Plan

Included in the Study Protocol and Clinical Study report

View Document

Related Links

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http://www.iso.org/standard/43633.html

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

Other Identifiers

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pfact 9806

Identifier Type: OTHER

Identifier Source: secondary_id

CPS 18-439

Identifier Type: -

Identifier Source: org_study_id