Glin3: Assessment of the Glycemic Responses to Nutritional Products (GLIN#3)

July 31, 2024 updated by: Nutricia Research

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
12

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Canada
      • Toronto, Canada, M5C 2N8
        • INQUIS Clinical Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Age ≥ 18 and ≤ 65 years
  • Body mass index (BMI) between 18.5 and 27 kg/m²

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: arm 1
All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized.
Dietary supplement: first reference product series 1
dextrose (containing 25 grams of carbohydrates)
Other: arm 2
All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized.
Dietary supplement: second reference product seies 1
dextrose (containing 25 grams of carbohydrates)
Other: arm 3
All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized.
Dietary supplement: third reference product series 1
dextrose (containing 25 grams of carbohydrates)
Other: arm 4
All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized.
Dietary supplement: first concept product series 1
Standard tube feed (containing 25 grams of carbohydrates)
Other: arm 5
All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized.
Dietary supplement: second concept product series 1
Tube feed with added fibers (containing 25 grams of carbohydrates)
Other: arm 6
All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized.
Dietary supplement: third concept product series 1
Tube feed with extra energy (containing 25 grams of carbohydrates)
Other: arm 7
All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized.
Dietary supplement: 4th concept product seris 1
Tube feed with extra energy and added fibers (containing 25 grams of carbohydrates)
Other: arm 8
All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized.
Dietary supplement: 5th concept product series 1
Plant based oral nutritional supplement for disease related malnutrition (containing 25 grams of carbohydrates
Other: arm 9
All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized.
Dietary supplement: 6th concept product series 1
Oral nutritional supplement for disease related malnutrition in patients with malabsorption and/or maldigestion (containing 25 grams of carbohydrates
Other: arm 10
All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized.
Dietary supplement: 1st reference product series 2
dextrose (containing 25 grams of carbohydrates)
Other: arm 11
All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized.
Dietary supplement: 2nd reference product series 2
dextrose (containing 25 grams of carbohydrates)
Other: arm 12
All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized.
Dietary supplement: 3rd reference product series 2
dextrose (containing 25 grams of carbohydrates)
Other: arm 13
All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized.
Dietary supplement: 1st concept product series 2
High energy plant based tube feed (containing 25 grams of carbohydrates)
Other: arm 14
All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized.
Dietary supplement: 2nd concept product series 2
High energy plant based tube feed with added fibers (containing 25 grams of carbohydrates)
Other: arm 15
All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized.
Dietary supplement: 3rd concept product series 2
High protein tube feed (containing 25 grams of carbohydrates)
Other: arm 16
All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized.
Dietary supplement: 4th concept product series 2
High protein, high energy tube feed based on peptides (containing 25 grams of carbohydrates)
Other: arm 17
All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized.
Dietary supplement: 5th concept product series 2
Oral nutritional supplement for disease related malnutrition in patients with muscle loss (containing 25 grams of carbohydrates)
Other: arm 18
All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized.
Dietary supplement: 6th concept product series 2
Oral nutritional supplement for disease related malnutrition (containing 25 grams of carbohydrates)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
The glycemic index of nutritional products
Time Frame: 6 months
6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
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
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
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Nutricia Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 7, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 12, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 12, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 10, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 10, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 22, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 1, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 31, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 23REX0060928

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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