Glycemic ResponseGLIN#2NCT05308147
Assessment of the Glycemic Responses to Nutritional Products (v2.0)
A study testing First Reference product, Second Reference product and Third Reference product in people with Glycemic Response, run by Nutricia Research at 1 site in Canada.
Trial summary
This study assesses the glycemic responses to nutritional products. During a study visit fasted subjects will consume one serving of the reference product or the test product. Capillary blood samples will be taken at baseline and at several time-points over a 2-hr period. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Glycemic Response
- What is being tested?
- First Reference product, Second Reference product and Third Reference product
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteCanada
- Study dates
- 17 Mar 2022to 31 May 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥ 18 and ≤ 65 years
- Body mass index (BMI) between 18.5 and 27 kg/m²
Who cannot join
- Known history of gastrointestinal disease, bariatric surgery, AIDS, hepatitis, a history or presence of clinically important endocrine (including Type 1 or Type 2 diabetes mellitus), or any condition which might, in the opinion of the medical director either: 1) make participation dangerous to the subject or to others, or 2)affect the results.
- Use of medications known to influence carbohydrate metabolism, gastrointestinal function or appetite, including, but not limited to adrenergic blockers, diuretics, thiazolidinediones, metformin and systemic corticosteroids within 4 weeks of the screening visit, or any medication which might, in the opinion of the medical director either: 1) make participation dangerous to the subject or to others, or 2) affect the results.
- Major trauma or surgical event within 3 months of screening.
- Known intolerance, sensitivity or allergy to test products.
- Extreme dietary habits, as judged by the Investigator (i.e. Atkins diet, very high protein diets, etc.).
- History of cancer in the prior two years, except for non-melanoma skin cancer.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
INQUIS Clinical Research, Ltd
Toronto, Ontario, M5C 2N8
Janice Campbell, 416-861-0506, info@inquis.com
Thomas Wolever, BM BCh PhD DM (Oxon)
About this study
Official title: Determination of the Postprandial Glycemic Response and Glycemic Index of Nutritional Products: A Randomized Controlled Clinical Trial in Healthy Individuals (v2.0)
This study assesses the glycemic responses to nutritional products. During a study visit fasted subjects will consume one serving of the reference product or the test product. Capillary blood samples will be taken at baseline and at several time-points over a 2-hr period. Several nutritional products will be tested over time.
- Conditions
- Glycemic Response
- Being tested
- First Reference product, Second Reference product, Third Reference product, First Concept product, Second Concept product
- Keywords
- Glycemic response, Glycemic index, Nutritional products, Healthy individuals
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
First Reference productDietary supplement
Dextrose (containing 25 grams of carbohydrates)
Second Reference productDietary supplement
Dextrose (containing 25 grams of carbohydrates)
Third Reference productDietary supplement
Dextrose (containing 25 grams of carbohydrates)
First Concept productDietary supplement
Infant Formula (containing 25 grams of carbohydrates)
Second Concept productDietary supplement
Infant Formula with new carbohydrate mixture 1 (containing 25 grams of carbohydrates)
Third Concept productDietary supplement
Infant Formula with new carbohydrate mixture 2 (containing 25 grams of carbohydrates)
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 (Reference) | Other | All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized. Receives: Dietary Supplement: First Reference product |
| Arm 2 (Reference) | Other | All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized. Receives: Dietary Supplement: Second Reference product |
| Arm 3 (Reference) | Other | All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized. Receives: Dietary Supplement: Third Reference product |
| Arm 4 (Concept) | Other | All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized. Receives: Dietary Supplement: First Concept product |
| Arm 5 (Concept) | Other | All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized. Receives: Dietary Supplement: Second Concept product |
| Arm 6 (Concept) | Other | All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized. Receives: Dietary Supplement: Third Concept product |
What is being measured
The primary outcome is the main question the study is designed to answer.
The glycemic index of nutritional products
Measured: 3 months
Secondary outcomes (2)
The postprandial glucose levels at each time point after each test product compared with the mean of the 3 references
Measured: 3 months
The postprandial incremental area under the curve (iAUC) after each test product compared with the mean of the 3 references
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2022
- Study start17 Mar 2022
- Primary completion30 Apr 2022 (estimated)
- Study completion31 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glycemic ResponseStudies of the same condition, open and under way.
- More trials run by Nutricia ResearchThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nutricia Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05308147
- Sponsor's protocol ID
- INQ-2137 v2.0
- Acronym
- GLIN#2
- Status last verified
- Mar 2022
- First submitted
- 11 Mar 2022
- Last updated
- 1 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of the Postprandial Glycemic Response and Glycemic Index of Nutritional Products: A Randomized Controlled Clinical Trial in Healthy Individuals (v2.0)
- ClinicalTrials.gov ID
- NCT05308147
- Acronym / sponsor ID
- GLIN#2 / INQ-2137 v2.0
- Conditions
- Glycemic Response
- Keywords
- Glycemic response, Glycemic index, Nutritional products, Healthy individuals
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Nutricia ResearchIndustry (pharma, biotech, devices)
- Study start
- 17 Mar 2022 (actual)
- Primary completion
- 30 Apr 2022 (estimated)
- Study completion
- 31 May 2022 (estimated)
- First posted
- 1 Apr 2022 (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.
This study assesses the glycemic responses to nutritional products. During a study visit fasted subjects will consume one serving of the reference product or the test product. Capillary blood samples will be taken at baseline and at several time-points over a 2-hr period. Several nutritional products will be tested over time.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Arm 1 (Reference) | Other | Dietary Supplement: First Reference productAll subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized. |
| Arm 2 (Reference) | Other | Dietary Supplement: Second Reference productAll subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized. |
| Arm 3 (Reference) | Other | Dietary Supplement: Third Reference productAll subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized. |
| Arm 4 (Concept) | Other | Dietary Supplement: First Concept productAll subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized. |
| Arm 5 (Concept) | Other | Dietary Supplement: Second Concept productAll subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized. |
| Arm 6 (Concept) | Other | Dietary Supplement: Third Concept productAll subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age ≥ 18 and ≤ 65 years
- Body mass index (BMI) between 18.5 and 27 kg/m²
Key exclusion criteria (6 listed)
- Known history of gastrointestinal disease, bariatric surgery, AIDS, hepatitis, a history or presence of clinically important endocrine (including Type 1 or Type 2 diabetes mellitus), or any condition which might, in the opinion of the medical director either: 1) make participation dangerous to the subject or to others, or 2)affect the results.
- Use of medications known to influence carbohydrate metabolism, gastrointestinal function or appetite, including, but not limited to adrenergic blockers, diuretics, thiazolidinediones, metformin and systemic corticosteroids within 4 weeks of the screening visit, or any medication which might, in the opinion of the medical director either: 1) make participation dangerous to the subject or to others, or 2) affect the results.
- Major trauma or surgical event within 3 months of screening.
- Known intolerance, sensitivity or allergy to test products.
- Extreme dietary habits, as judged by the Investigator (i.e. Atkins diet, very high protein diets, etc.).
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 |
|---|---|---|
| First Reference productDextrose (containing 25 grams of carbohydrates) | Dietary supplement | Arm 1 (Reference) |
| Second Reference productDextrose (containing 25 grams of carbohydrates) | Dietary supplement | Arm 2 (Reference) |
| Third Reference productDextrose (containing 25 grams of carbohydrates) | Dietary supplement | Arm 3 (Reference) |
| First Concept productInfant Formula (containing 25 grams of carbohydrates) | Dietary supplement | Arm 4 (Concept) |
| Second Concept productInfant Formula with new carbohydrate mixture 1 (containing 25 grams of carbohydrates) | Dietary supplement | Arm 5 (Concept) |
| Third Concept productInfant Formula with new carbohydrate mixture 2 (containing 25 grams of carbohydrates) | Dietary supplement | Arm 6 (Concept) |
Primary outcome
The glycemic index of nutritional products
Time frame: 3 months
2 secondary outcomes
The postprandial glucose levels at each time point after each test product compared with the mean of the 3 references
Time frame: 3 months
The postprandial incremental area under the curve (iAUC) after each test product compared with the mean of the 3 references
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2022.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing First Reference product, Second Reference product and Third Reference product in people with Glycemic Response, run by Nutricia Research at 1 site in Canada.
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 6 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: status not confirmed, as of the sponsor's last update on 1 Apr 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 Canada. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Danone Nutricia Research (+31 30 2095 000, register.clinicalresearchnutricia@danone.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The glycemic index of nutritional products (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Apr 2022.