Glucose Response to a Formula for Patients at Risk of Hypoglycaemia (EFFECT)

June 20, 2023 updated by: Nutricia Research
This study assesses the glycemic responses to several nutritional products.

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.

Detailed Description

During a study visit fasted subjects will consume one serving of the reference product or of the test products. Venous blood samples will be taken at baseline and at several time-points over a 6-hr period.

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.
18

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

  • Netherlands
      • Utrecht, Netherlands
        • EB UtrechtResearch BV

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 50 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Healthy individuals, 18 up to and including 50 years of age.
  2. Willing to maintain habitual diet, physical activity pattern, and body weight throughout the trial.
  3. Willing to avoid the consumption of alcohol, unusual food intake, unusual physical activity 24h prior to each study visit.
  4. Willing to come to the study visit in the morning after an overnight fast of minimum 10 hours and maximum 14 hours (with water only).

Exclusion Criteria:

  1. Blood glucose levels ≥ 7.8 mmol/L at screening (not fasted)
  2. Known history of gastrointestinal disease (e.g., diverticulitis, Crohn's disease, coeliac disease etc.), 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 Principal Investigator either: 1) make participation dangerous to the subject (e.g. anaemia) or to others, or 2) affect the results.
  3. 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 Principal Investigator either: 1) make participation dangerous to the subject or to others, or 2) affect the results.
  4. Use of medications known to influence gastric emptying (including but not limited to anticholinergics, nicotine, narcotic analgesics, ganglion blocking drugs, antacids and metoclopramide).
  5. Use of anti-clotting medications.
  6. Current tobacco smokers or smokers that quite smoking < 1 month prior to screening (except for occasional (≤ 3) cigarettes/cigars/pipes per week on average over the past month).
  7. Self-reported pregnancy or breastfeeding

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: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

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.
Active Comparator: Dietary supplement/First concept Product 1 (containing 50 grams of carbohydrates)
All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized.
Dietary supplement: First concept product (containing 50 grams of carbohydrates)
Fasted intake of First concept product (randomised)
Dietary supplement: Second concept product (containing 50 grams of carbohydrates)
Fasted intake Second concept product (randomised)
Dietary supplement: Reference product (containing 50 grams of carbohydrates)
Fasted intake of Reference product (randomised)
Active Comparator: Dietary supplement/First concept Product 2 (containing 50 grams of carbohydrates)
All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized
Dietary supplement: First concept product (containing 50 grams of carbohydrates)
Fasted intake of First concept product (randomised)
Dietary supplement: Second concept product (containing 50 grams of carbohydrates)
Fasted intake Second concept product (randomised)
Dietary supplement: Reference product (containing 50 grams of carbohydrates)
Fasted intake of Reference product (randomised)
Active Comparator: Reference product (containing 50 grams of carbohydrates)
All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized
Dietary supplement: First concept product (containing 50 grams of carbohydrates)
Fasted intake of First concept product (randomised)
Dietary supplement: Second concept product (containing 50 grams of carbohydrates)
Fasted intake Second concept product (randomised)
Dietary supplement: Reference product (containing 50 grams of carbohydrates)
Fasted intake of Reference product (randomised)

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
Decline in glucose level after reaching peak (Cmax)
Time Frame: 6 hours
The decline in glucose (mmol/hour) after reaching peak glucose levels (Cmax) until reaching baseline (t = -5) blood glucose levels or, in case baseline blood glucose levels are not reached, the lowest observed blood glucose level.
6 hours

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
Incremental Area Under the Curve (iAUC) for glucose
Time Frame: 6 hours
Incremental Area Under the Curve (iAUC) for glucose (mmol/L/hrs)
6 hours
Incremental Area Under the Curve (iAUC) for insulin
Time Frame: 6 hours
Incremental Area Under the Curve (iAUC) for insulin (pmol/L/hrs)
6 hours
Incremental Area Under the Curve (iAUC) for paracetamol
Time Frame: 6 hours
Incremental Area Under the Curve (iAUC) for paracetamol (pmol/L/hrs)
6 hours
Incremental peak levels (iCmax) of glucose
Time Frame: 6 hours
Incremental peak levels (iCmax) of glucose (mmol/L)
6 hours
Incremental peak levels (iCmax) of insulin
Time Frame: 6 hours
Incremental peak levels (iCmax) of insulin (pmol/L)
6 hours
Incremental peak levels (iCmax) of paracetamol
Time Frame: 6 hours
Incremental peak levels (iCmax) of paracetamol (mg/L)
6 hours
Time to peak levels (Tmax) of glucose
Time Frame: 6 hours
Time to peak levels (Tmax) of glucose (min)
6 hours
Time to peak levels (Tmax) of insulin
Time Frame: 6 hours
Time to peak levels (Tmax) of insulin (min)
6 hours
Time to peak levels (Tmax) of paracetamol
Time Frame: 6 hours
Time to peak levels (Tmax) of paracetamol (min)
6 hours

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 13, 2023

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.
March 30, 2023

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.
March 30, 2023

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).
December 12, 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.
December 22, 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.
January 9, 2023

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.
June 22, 2023

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.
June 20, 2023

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.
June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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&52507

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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