HealthyNCT04871971

Glycaemic Response and Insulinaemic Response for Nutralys S85 Plus and Whey Protein

A study testing 10 g NUTRALYS®S85 Plus pea protein, 20 g NUTRALYS®S85 Plus pea protein and 10 g Whey protein concentrate in people with Healthy, run by Oxford Brookes University at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

A comparison of the glycaemic response and insulinaemic response to glucose, Nutralys S85 Plus pea protein and whey protein using a single-blind, randomised, repeat measure, crossover design trial. Read more about this study

Who is it for?: Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: 10 g NUTRALYS®S85 Plus pea protein, 20 g NUTRALYS®S85 Plus pea protein and 10 g Whey protein concentrate
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 30 participants
Where: 1 siteUnited Kingdom
Study dates: 15 Sep 2021to 29 Aug 2022
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 60 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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

Who cannot join

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 locations and contacts

1 site in 1 country.

United Kingdom1 site

Oxford Brookes Centre for Nutrition and Health
Oxford, OX3 0BP

Other trials in United Kingdom

About this study

A comparison of the glycaemic response and insulinaemic response to glucose, Nutralys S85 Plus pea protein and whey protein using a single-blind, randomised, repeat measure, crossover design trial.

Read the detailed description

A single-blind, randomised, repeat measure, crossover design trial will be used to study the glycaemic response and insulinaemic response following consumption of five products: one reference product (50 g available carbohydrate Glucose) and four test products (50 g available carbohydrate Glucose with 10 g NUTRALYS®S85 Plus pea protein, 50 g available carbohydrate Glucose with 20 g NUTRALYS®S85 Plus pea protein, 50 g available carbohydrate Glucose with 10 g Whey protein concentrate and 50 g available carbohydrate Glucose with 20 g Whey protein concentrate).

Conditions: Healthy
Being tested: 10 g NUTRALYS®S85 Plus pea protein, 20 g NUTRALYS®S85 Plus pea protein, 10 g Whey protein concentrate, 20 g Whey protein concentrate, 50 g Glucose

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

10 g NUTRALYS®S85 Plus pea proteinDietary supplement
To determine the glycaemic response and insulinaemic response to 50g Glucose + 10 g NUTRALYS®S85 Plus pea protein.
20 g NUTRALYS®S85 Plus pea proteinDietary supplement
To determine the glycaemic response and insulinaemic response to 50g Glucose + 20 g NUTRALYS®S85 Plus pea protein.
10 g Whey protein concentrateDietary supplement
To determine the glycaemic response and insulinaemic response to 50g Glucose + 10 g Whey protein concentrate.
20 g Whey protein concentrateDietary supplement
To determine the glycaemic response and insulinaemic response to 50g Glucose + 20 g Whey protein concentrate.
50 g GlucoseDietary supplement
To determine the glycaemic response and insulinaemic response to 50g Glucose

Study groups in NCT04871971
Study group	Role	What they receive
Glucose	Placebo comparator	Glucose 50 g available carbohydrate Receives: Dietary Supplement: 50 g Glucose
10 g NUTRALYS®S85 Plus pea protein	Experimental	50 g available carbohydrate Glucose + 10 g NUTRALYS®S85 Plus pea protein Receives: Dietary Supplement: 10 g NUTRALYS®S85 Plus pea protein
20 g NUTRALYS®S85 Plus pea protein	Experimental	50 g available carbohydrate Glucose + 20 g NUTRALYS®S85 Plus pea protein Receives: Dietary Supplement: 20 g NUTRALYS®S85 Plus pea protein
10 g Whey protein concentrate	Experimental	50 g available carbohydrate Glucose + 10 g Whey protein concentrate Receives: Dietary Supplement: 10 g Whey protein concentrate
20 g Whey protein concentrate	Experimental	50 g available carbohydrate Glucose + 20 g Whey protein concentrate Receives: Dietary Supplement: 20 g Whey protein concentrate

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 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
Measured: 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
Measured: 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
Measured: 3 hours
Peak blood glucose concentration (Cmax)
Peak blood glucose concentration (Cmax) after consumption of the test food
Measured: 0-3 hours
Peak plasma insulin concentration (Cmax)
Peak plasma insulin concentration (Cmax) after consumption of the test food
Measured: 0-3 hours
Time of blood glucose peak (Tmax)
Time of blood glucose peak after consumption of the test food
Measured: 0-3 hours
Time of plasma insulin peak (Tmax)
Time of plasma insulin peak after consumption of the test food
Measured: 0-3 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Sep 202129 Aug 2022

First posted4 May 2021
Study start15 Sep 2021
Primary completion13 Jul 2022
Study completion29 Aug 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for HealthyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Model description: single-blind, randomised, repeat measure, crossover design trial
Masking: Single blind
Who is masked: Participant
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04871971
Sponsor's protocol ID: CPS-20-255
Other IDs: WT762123
Status last verified: Sep 2022
First submitted: 29 Apr 2021
Last updated: 7 Sep 2022
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 7 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Glycaemic Response and Insulinaemic Response for Nutralys S85 Plus and Whey Protein
ClinicalTrials.gov ID: NCT04871971
Acronym / sponsor ID: CPS-20-255
Conditions: Healthy
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: Oxford Brookes UniversityUniversity, hospital or other
Collaborators: Roquette Freres
Study start: 15 Sep 2021 (actual)
Primary completion: 13 Jul 2022 (actual)
Study completion: 29 Aug 2022 (actual)
First posted: 4 May 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

A comparison of the glycaemic response and insulinaemic response to glucose, Nutralys S85 Plus pea protein and whey protein using a single-blind, randomised, repeat measure, crossover design trial.

Detailed description

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (participant)
Number of arms: 5
Model description: single-blind, randomised, repeat measure, crossover design trial

Arm	Type	Receives
Glucose	Placebo comparator	Dietary Supplement: 50 g GlucoseGlucose 50 g available carbohydrate
10 g NUTRALYS®S85 Plus pea protein	Experimental	Dietary Supplement: 10 g NUTRALYS®S85 Plus pea protein50 g available carbohydrate Glucose + 10 g NUTRALYS®S85 Plus pea protein
20 g NUTRALYS®S85 Plus pea protein	Experimental	Dietary Supplement: 20 g NUTRALYS®S85 Plus pea protein50 g available carbohydrate Glucose + 20 g NUTRALYS®S85 Plus pea protein
10 g Whey protein concentrate	Experimental	Dietary Supplement: 10 g Whey protein concentrate50 g available carbohydrate Glucose + 10 g Whey protein concentrate
20 g Whey protein concentrate	Experimental	Dietary Supplement: 20 g Whey protein concentrate50 g available carbohydrate Glucose + 20 g Whey protein concentrate

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (2 listed)

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

Key exclusion criteria (8 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
10 g NUTRALYS®S85 Plus pea proteinTo determine the glycaemic response and insulinaemic response to 50g Glucose + 10 g NUTRALYS®S85 Plus pea protein.	Dietary supplement	10 g NUTRALYS®S85 Plus pea protein
20 g NUTRALYS®S85 Plus pea proteinTo determine the glycaemic response and insulinaemic response to 50g Glucose + 20 g NUTRALYS®S85 Plus pea protein.	Dietary supplement	20 g NUTRALYS®S85 Plus pea protein
10 g Whey protein concentrateTo determine the glycaemic response and insulinaemic response to 50g Glucose + 10 g Whey protein concentrate.	Dietary supplement	10 g Whey protein concentrate
20 g Whey protein concentrateTo determine the glycaemic response and insulinaemic response to 50g Glucose + 20 g Whey protein concentrate.	Dietary supplement	20 g Whey protein concentrate
50 g GlucoseTo determine the glycaemic response and insulinaemic response to 50g Glucose	Dietary supplement	Glucose

Primary outcome

Change in blood glucose response from baseline for 3 hours
Time frame: 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
Change in plasma insulin response from baseline for 3 hours
Time frame: 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
Area under the blood glucose concentration versus time curve
Time frame: 3 hours
Area under the blood glucose concentration versus time curve was calculated by trapezoidal rule
Area under the plasma insulin concentration versus time curve
Time frame: 3 hours
Area under the plasma insulin concentration versus time curve was calculated by trapezoidal rule
Peak blood glucose concentration (Cmax)
Time frame: 0-3 hours
Peak blood glucose concentration (Cmax) after consumption of the test food
Peak plasma insulin concentration (Cmax)
Time frame: 0-3 hours
Peak plasma insulin concentration (Cmax) after consumption of the test food
Time of blood glucose peak (Tmax)
Time frame: 0-3 hours
Time of blood glucose peak after consumption of the test food
Time of plasma insulin peak (Tmax)
Time frame: 0-3 hours
Time of plasma insulin peak after consumption of the test food

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2022.
Background: PubMed 20359723Siahanidou 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.
Food Products-Determination of the glycaemic index (GI) and recommendation for food classification.Link provided by the sponsor.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Sangeetha Thondre, PhD principal investigator

Oxford Brookes University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in blood glucose response from baseline for 3 hours (time frame: 3 hours). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04871971, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2022.