Bioequivalence of a Diabetes Specific Tube Feed (EQUIDIA)

January 21, 2025 updated by: Nutricia Research
Nutricia has a range of nutritionally complete tube feeds on the market including some specific for diabetes patients. A new product is currently under development. The aim of the present study is to assess whether the postprandial glucose response of the new product is equivalent to the postprandial glucose response of an original product. In addition, the Glycaemic Index (GI) and Glycaemic Load (GL) of the adapted product will be determined. The study will have a crossover design with healthy volunteers taking one serving of both products in a randomized order. To determine GI and GL of the adapted product subjects will also receive a reference product. Subjects will visit the study site six times: one screening visit, three study visits to measure the glucose response to the reference product and two study visits to measure the glucose response to the test and control product.

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.
22

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

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

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Age ≥ 18 and ≤ 65 years
  2. Body Mass Index (BMI) ≥ 18.5 and ≤ 27.0 kg/m2
  3. Written informed consent
  4. Willingness and ability to comply with the protocol
  5. Judged by the Investigator to be in good health

Exclusion Criteria:

  1. Known Diabetes Mellitus type I or type II, rebound hypoglycaemia and/or any other medical condition that interferes with glucose metabolism
  2. Any use of anticoagulants, systemic steroids, protease inhibitors or antipsychotics and/or any medication known to affect glucose tolerance and/or to influence digestion and absorption of nutrients within 1 week of screening, in opinion of the Investigator
  3. Any known disease which influences digestion and absorption of nutrients within 1 week of screening (in the opinion of the Investigator)
  4. Allergy to soy and/or any other known relevant food allergy or intolerance in opinion of the Investigator
  5. Adherence to a strict vegan diet
  6. Adherence to a weight loss program
  7. Picky/fussy eater (being very selective about what to eat) or eating disorder
  8. Known pregnancy and/or lactation
  9. Current smoking or stopped smoking for < 1 month prior to screening (except for incidental smoking of ≤ 3 cigarettes/cigars/pipes per week on average in the last month)
  10. Average alcohol use of > 21 glasses per week for men or > 14 glasses per week for women (on average during the last 6 months)
  11. Drug or medicine abuse in opinion of the Investigator
  12. Any known bleeding disorder
  13. Active participation in any other clinical study with investigational or marketed products concomitantly or within 4 weeks before study visit 1, in the opinion of the Investigator
  14. Major medical or surgical event requiring hospitalization within the preceding 3 months and/or scheduled in the period of study participation relevant in the opinion of the Investigator
  15. Investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements
  16. Employees of Nutricia Research and/or family members or relatives of employees

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: Single

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: New product - Original product
All subjects will receive first product A and then product B. In addition, the reference product will also be received (three times a glucose solution during the trial).
Dietary supplement: oral intake of one serving of the original and new product
1) Intervention type: Dietary Supplement Intervention name: (visits 1, 3 and 5) Reference product Intervention description: Glucose solution 2) Intervention type: Dietary Supplement Intervention name: (visit 2 or 4) Diabetes specific tube feed Intervention description: : One serving new product 3) Intervention type: : Dietary Supplement Intervention name: (visit 2 or 4) Diabetes specific tube feed Intervention description: One serving original product
Other: Original product - New product
All subjects will receive first product B and then product A. In addition, the reference product will also be received (three times a glucose solution during the trial).
Dietary supplement: oral intake of one serving of the original and new product
1) Intervention type: Dietary Supplement Intervention name: (visits 1, 3 and 5) Reference product Intervention description: Glucose solution 2) Intervention type: Dietary Supplement Intervention name: (visit 2 or 4) Diabetes specific tube feed Intervention description: : One serving new product 3) Intervention type: : Dietary Supplement Intervention name: (visit 2 or 4) Diabetes specific tube feed Intervention description: One serving original product

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
Measure Description
Time Frame
Blood glucose - Product A versus Product B
Time Frame: 120 minutes
Blood glucose iAUC0-120 [mmol/L*min] [mmol/L]
120 minutes
Blood glucose - Product A versus Product B
Time Frame: 120 minutes
Blood glucose iCmax [mmol/L] [mmol/L]
120 minutes

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
Measure Description
Time Frame
GI new product
Time Frame: 120 minutes
GI = blood glucose iAUC0-120 [mmol/L] of new product / mean blood glucose iAUC0-120 [mmol/L] of reference product
120 minutes
GL new product
Time Frame: 120 minutes
GL = GI * available carbohydrate/given amount of carbohydrate
120 minutes

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

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Monique Visser, PhD, 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.
September 7, 2022

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.
November 29, 2022

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.
November 29, 2022

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).
July 7, 2022

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.
July 7, 2022

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.
July 12, 2022

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.
March 25, 2025

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.
January 21, 2025

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.
January 1, 2025

More Information

Terms related to this study

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.
  • SBB22R&40700

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

product manufactured in and exported from the U.S.

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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