Glycemic ResponseGLIN#3NCT06215534
Glin3: Assessment of the Glycemic Responses to Nutritional Products
A study testing first reference product series 1, second reference product seies 1 and third reference product series 1 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 series 1, second reference product seies 1 and third reference product series 1
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteCanada
- Study dates
- 7 Feb 2024to 12 Jun 2024
- 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
- Baseline fasting Glucose ≥6.1 at screening visit
- 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 series 1, second reference product seies 1, third reference product series 1, first concept product series 1, second concept product series 1
- 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 series 1Dietary supplement
dextrose (containing 25 grams of carbohydrates)
second reference product seies 1Dietary supplement
dextrose (containing 25 grams of carbohydrates)
third reference product series 1Dietary supplement
dextrose (containing 25 grams of carbohydrates)
first concept product series 1Dietary supplement
Standard tube feed (containing 25 grams of carbohydrates)
second concept product series 1Dietary supplement
Tube feed with added fibers (containing 25 grams of carbohydrates)
third concept product series 1Dietary supplement
Tube feed with extra energy (containing 25 grams of carbohydrates)
4th concept product seris 1Dietary supplement
Tube feed with extra energy and added fibers (containing 25 grams of carbohydrates)
5th concept product series 1Dietary supplement
Plant based oral nutritional supplement for disease related malnutrition (containing 25 grams of carbohydrates
6th concept product series 1Dietary supplement
Oral nutritional supplement for disease related malnutrition in patients with malabsorption and/or maldigestion (containing 25 grams of carbohydrates
1st reference product series 2Dietary supplement
dextrose (containing 25 grams of carbohydrates)
2nd reference product series 2Dietary supplement
dextrose (containing 25 grams of carbohydrates)
3rd reference product series 2Dietary supplement
dextrose (containing 25 grams of carbohydrates)
1st concept product series 2Dietary supplement
High energy plant based tube feed (containing 25 grams of carbohydrates)
2nd concept product series 2Dietary supplement
High energy plant based tube feed with added fibers (containing 25 grams of carbohydrates)
3rd concept product series 2Dietary supplement
High protein tube feed (containing 25 grams of carbohydrates)
4th concept product series 2Dietary supplement
High protein, high energy tube feed based on peptides (containing 25 grams of carbohydrates)
5th concept product series 2Dietary supplement
Oral nutritional supplement for disease related malnutrition in patients with muscle loss (containing 25 grams of carbohydrates)
6th concept product series 2Dietary supplement
Oral nutritional supplement for disease related malnutrition (containing 25 grams of 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 series 1 |
| 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 seies 1 |
| 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 series 1 |
| arm 4 | 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 series 1 |
| arm 5 | 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 series 1 |
| arm 6 | 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 series 1 |
| arm 7 | Other | All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized. Receives: Dietary Supplement: 4th concept product seris 1 |
| arm 8 | Other | All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized. Receives: Dietary Supplement: 5th concept product series 1 |
| arm 9 | Other | All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized. Receives: Dietary Supplement: 6th concept product series 1 |
| arm 10 | Other | All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized. Receives: Dietary Supplement: 1st reference product series 2 |
| arm 11 | Other | All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized. Receives: Dietary Supplement: 2nd reference product series 2 |
| arm 12 | Other | All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized. Receives: Dietary Supplement: 3rd reference product series 2 |
| arm 13 | Other | All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized. Receives: Dietary Supplement: 1st concept product series 2 |
| arm 14 | Other | All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized. Receives: Dietary Supplement: 2nd concept product series 2 |
| arm 15 | Other | All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized. Receives: Dietary Supplement: 3rd concept product series 2 |
| arm 16 | Other | All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized. Receives: Dietary Supplement: 4th concept product series 2 |
| arm 17 | Other | All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized. Receives: Dietary Supplement: 5th concept product series 2 |
| arm 18 | Other | All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized. Receives: Dietary Supplement: 6th concept product series 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The glycemic index of nutritional products
Measured: 6 months
Secondary outcomes (2)
1. The postprandial glucose levels at each time point after each test product compared with the mean of the 3 references
Measured: 6 months
2. The postprandial incremental area under the curve (iAUC) after each test product compared with the mean of the 3 references
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2024
- Study start7 Feb 2024
- Primary completion12 Jun 2024
- Study completion12 Jun 2024
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
- Model description
- 12 products will be tested (2 x 6 products + each 3 contls) that means 18 ärms"in total
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nutricia Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06215534
- Sponsor's protocol ID
- 23REX0060928
- Acronym
- GLIN#3
- Status last verified
- Jul 2024
- First submitted
- 10 Jan 2024
- Last updated
- 1 Aug 2024
- 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 Aug 2024. 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
- NCT06215534
- Acronym / sponsor ID
- GLIN#3 / 23REX0060928
- Conditions
- Glycemic Response
- Keywords
- Glycemic response, Glycemic Index, Nutritional products, Healthy individuals
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Nutricia ResearchIndustry (pharma, biotech, devices)
- Study start
- 7 Feb 2024 (actual)
- Primary completion
- 12 Jun 2024 (actual)
- Study completion
- 12 Jun 2024 (actual)
- First posted
- 22 Jan 2024 (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
- 18
- Model description
- 12 products will be tested (2 x 6 products + each 3 contls) that means 18 ärms"in total
| Arm | Type | Receives |
|---|---|---|
| arm 1 | Other | Dietary Supplement: first reference product series 1All 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 seies 1All 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 series 1All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized. |
| arm 4 | Other | Dietary Supplement: first concept product series 1All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized. |
| arm 5 | Other | Dietary Supplement: second concept product series 1All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized. |
| arm 6 | Other | Dietary Supplement: third concept product series 1All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized. |
| arm 7 | Other | Dietary Supplement: 4th concept product seris 1All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized. |
| arm 8 | Other | Dietary Supplement: 5th concept product series 1All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized. |
| arm 9 | Other | Dietary Supplement: 6th concept product series 1All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized. |
| arm 10 | Other | Dietary Supplement: 1st reference product series 2All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized. |
| arm 11 | Other | Dietary Supplement: 2nd reference product series 2All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized. |
| arm 12 | Other | Dietary Supplement: 3rd reference product series 2All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized. |
| arm 13 | Other | Dietary Supplement: 1st concept product series 2All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized. |
| arm 14 | Other | Dietary Supplement: 2nd concept product series 2All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized. |
| arm 15 | Other | Dietary Supplement: 3rd concept product series 2All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized. |
| arm 16 | Other | Dietary Supplement: 4th concept product series 2All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized. |
| arm 17 | Other | Dietary Supplement: 5th concept product series 2All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized. |
| arm 18 | Other | Dietary Supplement: 6th concept product series 2All 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 (7 listed)
- Baseline fasting Glucose ≥6.1 at screening visit
- 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.
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 series 1dextrose (containing 25 grams of carbohydrates) | Dietary supplement | arm 1 |
| second reference product seies 1dextrose (containing 25 grams of carbohydrates) | Dietary supplement | arm 2 |
| third reference product series 1dextrose (containing 25 grams of carbohydrates) | Dietary supplement | arm 3 |
| first concept product series 1Standard tube feed (containing 25 grams of carbohydrates) | Dietary supplement | arm 4 |
| second concept product series 1Tube feed with added fibers (containing 25 grams of carbohydrates) | Dietary supplement | arm 5 |
| third concept product series 1Tube feed with extra energy (containing 25 grams of carbohydrates) | Dietary supplement | arm 6 |
| 4th concept product seris 1Tube feed with extra energy and added fibers (containing 25 grams of carbohydrates) | Dietary supplement | arm 7 |
| 5th concept product series 1Plant based oral nutritional supplement for disease related malnutrition (containing 25 grams of carbohydrates | Dietary supplement | arm 8 |
| 6th concept product series 1Oral nutritional supplement for disease related malnutrition in patients with malabsorption and/or maldigestion (containing 25 grams of carbohydrates | Dietary supplement | arm 9 |
| 1st reference product series 2dextrose (containing 25 grams of carbohydrates) | Dietary supplement | arm 10 |
| 2nd reference product series 2dextrose (containing 25 grams of carbohydrates) | Dietary supplement | arm 11 |
| 3rd reference product series 2dextrose (containing 25 grams of carbohydrates) | Dietary supplement | arm 12 |
| 1st concept product series 2High energy plant based tube feed (containing 25 grams of carbohydrates) | Dietary supplement | arm 13 |
| 2nd concept product series 2High energy plant based tube feed with added fibers (containing 25 grams of carbohydrates) | Dietary supplement | arm 14 |
| 3rd concept product series 2High protein tube feed (containing 25 grams of carbohydrates) | Dietary supplement | arm 15 |
| 4th concept product series 2High protein, high energy tube feed based on peptides (containing 25 grams of carbohydrates) | Dietary supplement | arm 16 |
| 5th concept product series 2Oral nutritional supplement for disease related malnutrition in patients with muscle loss (containing 25 grams of carbohydrates) | Dietary supplement | arm 17 |
| 6th concept product series 2Oral nutritional supplement for disease related malnutrition (containing 25 grams of carbohydrates) | Dietary supplement | arm 18 |
Primary outcome
The glycemic index of nutritional products
Time frame: 6 months
2 secondary outcomes
1. The postprandial glucose levels at each time point after each test product compared with the mean of the 3 references
Time frame: 6 months
2. The postprandial incremental area under the curve (iAUC) after each test product compared with the mean of the 3 references
Time frame: 6 months
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 1 Aug 2024.
- Individual participant dataSharing planned: No
Related trials for Glycemic Response
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
RecruitingObservational study
Food-i-Sense Analytics: Integrating AI Into Continuous Glucose Monitoring Data Analysis for Precision Nutrition.
Prediabetes (Insulin Resistance, Impaired Glucose Tolerance), Artificial Intelligence Mobile Application
Active, not recruiting
Postprandial Glycemic and GLP-1 Responses to Modified Full-sugar Drinks
Postprandial Glucose, GLP-1 Concentration
Not yet recruiting
SUVY VerSus SAccharose (SUVISA)
Healthy Volunteers, Erythritol
Not yet recruiting
A Crossover Study Evaluating the Postprandial Glycemic Response of Three Sweeteners in a Mixed Meal Setting
Postprandial Glucose, GI Tolerance
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 series 1, second reference product seies 1 and third reference product series 1 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 7 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 1 Aug 2024. 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: 6 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 Aug 2024.