Glycemic ResponseGLIN#1NCT05179031
Assessment of the Glycemic Responses to Nutritional Products
A study testing First Reference product (dextrose, containing 25 g of carbohydrates), Second Reference product (dextrose, containing 25 g of carbohydrates) and Third Reference product (dextrose, containing 25 g of carbohydrates) 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 (dextrose, containing 25 g of carbohydrates), Second Reference product (dextrose, containing 25 g of carbohydrates) and Third Reference product (dextrose, containing 25 g of carbohydrates)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteCanada
- Study dates
- 4 Jan 2022to 11 Mar 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.
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
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 (dextrose, containing 25 g of carbohydrates), Second Reference product (dextrose, containing 25 g of carbohydrates), Third Reference product (dextrose, containing 25 g of carbohydrates), High protein tube feed, High-protein tube feed with additional amino acid
- 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 product (dextrose, containing 25 g of carbohydrates)Dietary supplement
Reference dextrose solution containing 25 g of available carbohydrates
Second Reference product (dextrose, containing 25 g of carbohydrates)Dietary supplement
Reference dextrose solution containing 25 g of available carbohydrates
Third Reference product (dextrose, containing 25 g of carbohydrates)Dietary supplement
Reference dextrose solution containing 25 g of available carbohydrates
High protein tube feedDietary supplement
Nutritional product containing 25 g of available carbohydrates
High-protein tube feed with additional amino acidDietary supplement
Nutritional product containing 25 g of available carbohydrates
Oral Nutritional Supplement for diabetes patientsDietary supplement
Nutritional product containing 25 g of available carbohydrates
Oral Nutritional Supplement for diabetes patients (new formula)Dietary supplement
Nutritional product containing 25 g of available carbohydrates
ONS for disease related malnutritionDietary supplement
Nutritional product containing 25 g of available carbohydrates
Plantbased ONS for disease related malnutritionDietary supplement
Nutritional product containing 25 g of available carbohydrates
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | 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 (dextrose, containing 25 g of carbohydrates) |
| Arm 2 | 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 (dextrose, containing 25 g of carbohydrates) |
| Arm 3 | 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 (dextrose, containing 25 g of carbohydrates) |
| Arm 4 | Other | All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized. Receives: Dietary Supplement: High protein tube feed |
| Arm 5 | Other | All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized. Receives: Dietary Supplement: High-protein tube feed with additional amino acid |
| Arm 6 | Other | All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized. Receives: Dietary Supplement: Oral Nutritional Supplement for diabetes patients |
| Arm 7 | Other | All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized. Receives: Dietary Supplement: Oral Nutritional Supplement for diabetes patients (new formula) |
| Arm 8 | Other | All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized. Receives: Dietary Supplement: ONS for disease related malnutrition |
| Arm 9 | Other | All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized. Receives: Dietary Supplement: Plantbased ONS for disease related malnutrition |
What is being measured
The primary outcome is the main question the study is designed to answer.
The glycemic index of nutritional products
Measured: 9 test days (test days will be separated by at least 1 day in between tests for each participant)
Secondary outcomes (2)
The postprandial glucose levels at each time point after each test product compared with the mean of the 3 references
Measured: 9 test days (test days will be separated by at least 1 day in between tests for each participant)
The postprandial incremental area under the curve (iAUC) after each test product compared with the mean of the 3 references
Measured: 9 test days (test days will be separated by at least 1 day in between tests for each participant)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2022
- Study start4 Jan 2022
- Primary completion11 Mar 2022
- Study completion11 Mar 2022
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
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nutricia Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- INQUIS Clinical Research
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05179031
- Sponsor's protocol ID
- INQ-2137
- Acronym
- GLIN#1
- Status last verified
- Mar 2022
- First submitted
- 14 Dec 2021
- Last updated
- 15 Mar 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 15 Mar 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
- ClinicalTrials.gov ID
- NCT05179031
- Acronym / sponsor ID
- GLIN#1 / INQ-2137
- Conditions
- Glycemic Response
- Keywords
- Glycemic response, Glycemic index, Nutritional products, Healthy individuals
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Nutricia ResearchIndustry (pharma, biotech, devices)
- Collaborators
- INQUIS Clinical Research
- Study start
- 4 Jan 2022 (actual)
- Primary completion
- 11 Mar 2022 (actual)
- Study completion
- 11 Mar 2022 (actual)
- First posted
- 5 Jan 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
- 9
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Other | Dietary Supplement: First Reference product (dextrose, containing 25 g of carbohydrates)All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized. |
| Arm 2 | Other | Dietary Supplement: Second Reference product (dextrose, containing 25 g of carbohydrates)All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized. |
| Arm 3 | Other | Dietary Supplement: Third Reference product (dextrose, containing 25 g of carbohydrates)All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized. |
| Arm 4 | Other | Dietary Supplement: High protein tube feedAll subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized. |
| Arm 5 | Other | Dietary Supplement: High-protein tube feed with additional amino acidAll subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized. |
| Arm 6 | Other | Dietary Supplement: Oral Nutritional Supplement for diabetes patientsAll subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized. |
| Arm 7 | Other | Dietary Supplement: Oral Nutritional Supplement for diabetes patients (new formula)All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized. |
| Arm 8 | Other | Dietary Supplement: ONS for disease related malnutritionAll subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized. |
| Arm 9 | Other | Dietary Supplement: Plantbased ONS for disease related malnutritionAll 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 product (dextrose, containing 25 g of carbohydrates)Reference dextrose solution containing 25 g of available carbohydrates | Dietary supplement | Arm 1 |
| Second Reference product (dextrose, containing 25 g of carbohydrates)Reference dextrose solution containing 25 g of available carbohydrates | Dietary supplement | Arm 2 |
| Third Reference product (dextrose, containing 25 g of carbohydrates)Reference dextrose solution containing 25 g of available carbohydrates | Dietary supplement | Arm 3 |
| High protein tube feedNutritional product containing 25 g of available carbohydrates | Dietary supplement | Arm 4 |
| High-protein tube feed with additional amino acidNutritional product containing 25 g of available carbohydrates | Dietary supplement | Arm 5 |
| Oral Nutritional Supplement for diabetes patientsNutritional product containing 25 g of available carbohydrates | Dietary supplement | Arm 6 |
| Oral Nutritional Supplement for diabetes patients (new formula)Nutritional product containing 25 g of available carbohydrates | Dietary supplement | Arm 7 |
| ONS for disease related malnutritionNutritional product containing 25 g of available carbohydrates | Dietary supplement | Arm 8 |
| Plantbased ONS for disease related malnutritionNutritional product containing 25 g of available carbohydrates | Dietary supplement | Arm 9 |
Primary outcome
The glycemic index of nutritional products
Time frame: 9 test days (test days will be separated by at least 1 day in between tests for each participant)
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: 9 test days (test days will be separated by at least 1 day in between tests for each participant)
The postprandial incremental area under the curve (iAUC) after each test product compared with the mean of the 3 references
Time frame: 9 test days (test days will be separated by at least 1 day in between tests for each participant)
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 15 Mar 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.
The record lists no contact. Use the official record to reach the sponsor.
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 (dextrose, containing 25 g of carbohydrates), Second Reference product (dextrose, containing 25 g of carbohydrates) and Third Reference product (dextrose, containing 25 g of carbohydrates) 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: finished, as of the sponsor's last update on 15 Mar 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?
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?
The glycemic index of nutritional products (time frame: 9 test days (test days will be separated by at least 1 day in between tests for each participant)). 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 15 Mar 2022.