HealthyNCT04610203
Glycaemic Response, Insulinaemic Response, GLP-1 and GIP Testing of Food Product Lines
A study testing 25 g Nutralys Pea Protein, 50 g Nutralys S85 Plus. and 50 g Glucose in people with Healthy, run by Oxford Brookes University at 1 site in United Kingdom.
Trial 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 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?
- 25 g Nutralys Pea Protein, 50 g Nutralys S85 Plus. and 50 g Glucose
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 41 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 3 Dec 2018to 30 Sep 2019
- 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
About this study
Official title: 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.
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
- Conditions
- Healthy
- Being tested
- 25 g Nutralys Pea Protein, 50 g Nutralys S85 Plus., 50 g Glucose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
25 g Nutralys Pea ProteinDietary supplement
To determine the glycaemic response, insulinaemic response, GIP response and GLP-1 response to 50g Glucose +25g Nutralys S85 Plus
50 g Nutralys S85 Plus.Dietary supplement
To determine the glycaemic response, insulinaemic response, GIP response and GLP-1 response to 50g Glucose+50 g Nutralys S85 Plus .
50 g GlucoseDietary supplement
To determine the glycaemic response, insulinaemic response, GIP response and GLP-1 response to 50g Glucose
| Study group | Role | What they receive |
|---|---|---|
| Glucose | Placebo comparator | Glucose - 50 g Receives: Dietary Supplement: 50 g Glucose |
| Nutralys S85 Plus 25 g | Experimental | Nutralys S85 Plus Pea Protein 25 g + 50 g Glucose Receives: Dietary Supplement: 25 g Nutralys Pea Protein |
| Nutralys S85 Plus 50 g | Experimental | Nutralys S85 Plus Pea Protein 50 g + 50 g Glucose Receives: Dietary Supplement: 50 g Nutralys S85 Plus. |
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
Secondary outcomes (8)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 3 hours
Peak plasma GLP-1 concentration (Cmax)
Peak plasma GLP-1 concentration (Cmax) after consumption of the test food
Measured: 0-3 hours
Peak plasma GIP concentration (Cmax)
Peak plasma GIP concentration (Cmax) after consumption of the test food
Measured: 0-3 hours
Time of plasma GLP-1 peak (Tmax)
Time of plasma GLP-1 peak after consumption of the test food
Measured: 0-3 hours
Time of plasma GIP peak (Tmax)
Time of plasma GIP 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.
- First posted30 Oct 2020
- Study start3 Dec 2018
- Primary completion5 Jul 2019
- Study completion30 Sep 2019
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
- randomised, repeat measure, crossover design trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oxford Brookes University
- Sponsor type
- University, hospital or other
- Collaborators
- Roquette Freres
- Responsible party
- Principal investigator, Dr. Sangeetha Thondre, Oxford Brookes University
- Investigators
- Sangeetha Thondre, PhD, Principal investigator, Oxford Brookes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04610203
- Sponsor's protocol ID
- CPS 18-439
- Other IDs
- pfact 9806
- Status last verified
- Oct 2020
- First submitted
- 10 Oct 2020
- Last updated
- 2 Nov 2020
- 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
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04610203
- Acronym / sponsor ID
- CPS 18-439
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Oxford Brookes UniversityUniversity, hospital or other
- Collaborators
- Roquette Freres
- Study start
- 3 Dec 2018 (actual)
- Primary completion
- 5 Jul 2019 (actual)
- Study completion
- 30 Sep 2019 (actual)
- First posted
- 30 Oct 2020 (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.
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
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- randomised, repeat measure, crossover design trial
| Arm | Type | Receives |
|---|---|---|
| Glucose | Placebo comparator | Dietary Supplement: 50 g GlucoseGlucose - 50 g |
| Nutralys S85 Plus 25 g | Experimental | Dietary Supplement: 25 g Nutralys Pea ProteinNutralys S85 Plus Pea Protein 25 g + 50 g Glucose |
| Nutralys S85 Plus 50 g | Experimental | Dietary Supplement: 50 g Nutralys S85 Plus.Nutralys S85 Plus Pea Protein 50 g + 50 g Glucose |
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 |
|---|---|---|
| 25 g Nutralys Pea ProteinTo determine the glycaemic response, insulinaemic response, GIP response and GLP-1 response to 50g Glucose +25g Nutralys S85 Plus | Dietary supplement | Nutralys S85 Plus 25 g |
| 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 . | Dietary supplement | Nutralys S85 Plus 50 g |
| 50 g GlucoseTo determine the glycaemic response, insulinaemic response, GIP response and GLP-1 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
8 secondary outcomes
Change in GLP-1 from baseline for 3 hours
Time frame: 3 hours
Change in GIP from baseline for 3 hours
Time frame: 3 hours
Area under the plasma GLP-1 concentration versus time curve
Time frame: 3 hours
Area under the plasma GIP concentration versus time curve
Time frame: 3 hours
Peak plasma GLP-1 concentration (Cmax)
Time frame: 0-3 hours
Peak plasma GIP concentration (Cmax)
Time frame: 0-3 hours
Time of plasma GLP-1 peak (Tmax)
Time frame: 0-3 hours
Time of plasma GIP peak (Tmax)
Time frame: 0-3 hours
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 2 Nov 2020.
- 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.
- 23\. 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?
A study testing 25 g Nutralys Pea Protein, 50 g Nutralys S85 Plus. and 50 g Glucose in people with Healthy, run by Oxford Brookes University at 1 site in United Kingdom.
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 2 Nov 2020. 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 NCT04610203, 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 2 Nov 2020.