Tolerance and Safety of an Oral Nutritional Supplement (Adolescent Cohort)

October 16, 2023 updated by: Société des Produits Nestlé (SPN)

Tolerance and Safety of an Oral Nutritional Supplement Containing Monoacylglycerol Oil (MAG Oil) as the Main Lipid Source in Healthy Adolescents

This is an open label, non-randomized, interventional, single arm study.

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

The primary objective is to assess whether the MAG oil-containing study formula is well tolerated and safe when used as an ONS in healthy adolescents.

Hypothesis: The study product will be safe and well tolerated in healthy adolescents (as previously observed in adults).

Secondary objectives:

  1. Describe the frequency and characteristics of possible gastrointestinal intolerance symptoms
  2. Describe stool characteristics specifically stool frequency and consistency
  3. Describe changes in anthropometric parameters, particularly weight and body mass index (BMI)
  4. Describe changes in blood parameters of lipid metabolism
  5. Describe changes in hematological and serum biochemistry parameters
  6. Describe daily ONS intake and overall compliance

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 Locations

  • Switzerland
      • Lausanne, Switzerland
        • Clinical Innovation Lab.

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

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Healthy volunteers aged 12-17 years
  2. BMI range between the 10th and 90th percentile according to the Swiss growth charts with a minimum body weight of 40 kg.
  3. Deemed able to comply with study protocol for the study period
  4. Able to obtain written informed consent from participants and legally authorized representative(s)

Exclusion Criteria:

  1. Pre-existing chronic medical or psychiatric conditions.
  2. History of a chronic gastrointestinal disorder (e.g., inflammatory bowel disease, irritable bowel syndrome, celiac disease etc.), or chronic or recurrent gastrointestinal symptoms, including self-reported symptoms such as abdominal pain.
  3. Recent episode of an acute gastrointestinal illness with significant gastrointestinal symptoms in the 7 days prior to enrolment.
  4. History of chronic constipation (with passage of fewer than 3 spontaneous bowel movements per week on average or history of painful or hard bowel movements), OR chronic or intermittent diarrhea with loose or watery bowel movements ≥ 3 times per day.
  5. Colonoscopy or other bowel cleansing procedures within 4 weeks prior to enrolment.
  6. Prior use of prescription medication(s), in particular antibiotics, antiacids, laxatives, antidiarrheal agents or other medications impacting gastrointestinal transit time, within 3 weeks prior to enrolment.
  7. Significant medical or surgical event in the past 3 months potentially interfering with study procedures and assessments.
  8. Subjects following a weight loss program including a low-carbohydrate or low-fat diet, ketogenic diet, intermittent fasting, or any other special diet.
  9. Known food allergy in particular cow's milk protein allergy or known/suspected hypersensitivity or intolerance to any other ingredients in the study product. Subjects experiencing gastrointestinal symptoms when consuming dairy products or avoiding dairy in their diet should not participate in the study.
  10. Subjects taking energy or protein supplements.
  11. Known alcohol or substance abuse.
  12. Pregnant or lactating females or having given birth in the past 6 months prior to enrolment. Pregnancy will be ruled out by performing a standard urine dipstick test to female participants of childbearing potential prior to enrolment.
  13. Family or hierarchical relationships with Clinical Innovation Lab staff

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: N/A
  • Interventional Model: Single Group 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.
Experimental: Oral nutritional supplement
Oral nutritional supplement that contains MAG oil
Dietary supplement: MAG oil oral nutritional supplement (ONS)
The study product is suitable for use as an oral nutritional supplement (ONS).The study product contains MAG oil.

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
Number of subjects who develop significant gastrointestinal adverse events (deemed probably related or related to study product as per investigator's opinion) leading to discontinuation of the study product and withdrawal from the study
Time Frame: Day 2 to Day 15
Number of subjects who develop significant gastrointestinal adverse events leading to discontinuation of the study product and withdrawal from the study
Day 2 to Day 15

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
Severity of gastrointestinal intolerance symptoms
Time Frame: Day 1 to Day 15
Individual gastrointestinal symptom scores assessed by the Visual Analogue Scale (VAS) tool from 0 (no symptom) to 10 (maximum severity)
Day 1 to Day 15
Change in stool frequency
Time Frame: Day 1 to Day 15
Assessed by a questionnaire on daily number of stools
Day 1 to Day 15
Changes in lipid profile in the blood
Time Frame: Day 1 and Day 15
Triglycerides, cholesterol (total cholesterol, LDL cholesterol and HDL cholesterol) measured in plasma
Day 1 and Day 15
Changes in liver function tests in the blood
Time Frame: Day 1 and Day 15
ALAT measured in plasma
Day 1 and Day 15
Changes in liver function tests in the blood
Time Frame: Day 1 and Day 15
ASAT measured in plasma
Day 1 and Day 15
Changes in liver function tests in the blood
Time Frame: Day 1 and Day 15
phosphatase alkaline measured in plasma
Day 1 and Day 15
Changes in liver function tests in the blood
Time Frame: Day 1 and Day 15
Gamma glutamyl transferase measured in plasma
Day 1 and Day 15
Changes in liver function tests in the blood
Time Frame: Day 1 and Day 15
Total and direct bilirubin measured in plasma
Day 1 and Day 15
Changes in liver function tests in the blood
Time Frame: Day 1 and Day 15
Protein and albumin measured in plasma
Day 1 and Day 15
Changes in renal function tests in the blood
Time Frame: Day 1 and Day 15
Urea, creatinine measured in plasma
Day 1 and Day 15
Changes in blood chemistry tests
Time Frame: Day 1 and Day 15
C-Reactive Protein measured in serum
Day 1 and Day 15
Changes in blood chemistry tests
Time Frame: Day 1 and Day 15
Glucose measured in serum
Day 1 and Day 15
Changes in blood chemistry tests
Time Frame: Day 1 and Day 15
Sodium measured in serum
Day 1 and Day 15
Changes in blood chemistry tests
Time Frame: Day 1 and Day 15
Potassium measured in serum
Day 1 and Day 15
Changes in blood chemistry tests
Time Frame: Day 1 and Day 15
Calcium measured in serum
Day 1 and Day 15
Changes in blood chemistry tests
Time Frame: Day 1 and Day 15
Phosphate measured in serum
Day 1 and Day 15
Changes in blood chemistry tests
Time Frame: Day 1 and Day 15
Magnesium measured in serum
Day 1 and Day 15
Changes in blood chemistry tests
Time Frame: Day 1 and Day 15
Chloride measured in serum
Day 1 and Day 15
Daily intake of study product
Time Frame: Day 1 to Day 15
Number of participants adhering to daily intake of the study product assessed by a daily questionnaire
Day 1 to Day 15
Changes in full blood count
Time Frame: Day 1 and Day 15
thrombocyte count
Day 1 and Day 15
Changes in full blood count
Time Frame: Day 1 and Day 15
Erythrocyte count
Day 1 and Day 15
Changes in full blood count
Time Frame: Day 1 and Day 15
haemoglobin measured in blood
Day 1 and Day 15
Changes in full blood count
Time Frame: Day 1 and Day 15
haematocrit measured in blood
Day 1 and Day 15
Changes in full blood count
Time Frame: Day 1 and Day 15
mean cell hemoglobin concentation measured in Blood
Day 1 and Day 15
Changes in fatty acids profile
Time Frame: Day 1 and Day 15
Plasma and erythrocytes fatty acids profile
Day 1 and Day 15
Change in Vitamin A level
Time Frame: Day 1 and Day 15
Change in serum Vitamin A
Day 1 and Day 15
Change in 25-hydroxy vitamin D level
Time Frame: Day 1 and Day 15
Change in serum 25-hydroxy vitamin D
Day 1 and Day 15
Change in vitamin E level
Time Frame: Day 1 and Day 15
Change in serum vitamin E
Day 1 and Day 15
Changes in Vitamin K level
Time Frame: Day 1 and Day 15
change in international normalized ratio
Day 1 and Day 15
Changes in in fat-soluble vitamins
Time Frame: Day 1 and Day 15
Vitamin E/cholesterol ratio measured in plasma
Day 1 and Day 15
Severity of gastrointestinal intolerance symptoms
Time Frame: Day 1 and Day 15
Individual gastrointestinal symptom scores assessed by the Gastrointestinal Symptom Rating Scale (GSRS) questionnaire from No discomfort at all (no discomfort) to Very severe discomfort (maximum discomfort)
Day 1 and Day 15
Change in stool consistency
Time Frame: Day 1 to Day 15
Assessed by Bristol Stool Scale from stool consistency A (Separate hard lumps, like nuts, hard to pass) to G (Watery, no solid pieces)
Day 1 to Day 15
Change in weight
Time Frame: Day 1 and Day 15
Measured with a weight scale
Day 1 and Day 15
Change in BMI
Time Frame: Day 1 and Day 15
Measured with a weight scale and size scale
Day 1 and Day 15

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.
Société des Produits Nestlé (SPN)

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: Pamela Sun, Neslté

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.
March 20, 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.
June 15, 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.
August 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).
February 27, 2023

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.
June 27, 2023

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.
June 28, 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.
October 18, 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.
October 16, 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.
October 1, 2023

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.
  • 2214NR

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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