Tolerance and Safety of an Oral Nutritional Supplement (Glaze)

March 31, 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 and Adults

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.
Terminated

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

Primary objective is to assess whether the MAG oil (monoacylglycerol oil) containing study formula is well tolerated and safe when used as an ONS in healthy adults and adolescents.

Secondary objectives:

  1. Describe the incidence and characteristics of possible gastrointestinal intolerance symptoms
  2. Describe changes in 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 assess dietary adherence to the study protocol

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, 1000
        • Nestlé CDU / 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

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy volunteers
  • BMI range from >18 to <28 kg/m2 for adults with a minimum body weight of 45 kg
  • BMI range between the 25th and 90th percentile according to the Swiss growth charts for adolescents with a minimum body weight of 40 kg
  • Cohort 1: Adults aged 18+ years (6 males, 6 females)
  • Cohort 2: Adolescents aged 12-17 years (6 males, 6 females)
  • Deemed able to comply with study protocol for 2 weeks
  • Able to obtain written informed consent from participants and /or legal guardians

Exclusion Criteria:

  • Pre-existing chronic medical or psychiatric conditions, as diagnosed by the treating physician
  • Subjects taking dietary supplements (energy supplements, protein supplements) will be excluded. Subjects can continue taking vitamin or herbal supplements during the study period.
  • Abnormal bowel transit, history of a gastrointestinal disorder (e.g., inflammatory bowel disease (IBD), diverticular disease, colon cancer, irritable bowel syndrome (IBS), history of chronic constipation with passage of fewer than 3 spontaneous bowel movements per week on average, or chronic or recurrent diarrhea with loose or watery bowel movements more than 3 times daily.
  • Recent episode of an acute gastrointestinal illness with significant gastrointestinal symptoms in the 7 days prior to enrolment.
  • Colonoscopy or other bowel cleansing procedures within 4 weeks prior to enrolment.
  • Prior use of prescription medication(s), in particular antibiotics, antacids, laxatives or other medications impacting gastrointestinal transit time, within 8 weeks prior to enrolment.
  • Significant medical or surgical event in the past 3 months potentially interfering with study procedures and assessments.
  • Known food allergy in particular cow's milk protein allergy (CMPA) or known hypersensitivity/intolerance to any other ingredients in the study product.
  • Known alcohol or substance abuse; specifically, alcohol intake > 2 servings per day. A serving is 0.4 dl of strong alcohols, 1 dl of red or white wine, or 3 dl of beer.
  • Pregnant or lactating women or having given birth in the past 6 months prior to enrolment.
  • 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, hydrolyzed whey protein, simple carbohydrates, vitamins and minerals.

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 gastrointestinal intolerance leading to premature discontinuation
Time Frame: [ Time Frame: Day 2 to Day 15 ]
Number of subjects who develop gastrointestinal intolerance reported as adverse events related to the investigational product and leading to premature discontinuation of the study product, assessed by a daily questionnaire
[ Time Frame: 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: [ Time Frame: Day 2 to Day 14 ]
Visual analog scale from 0 (no symptom) to 10 (maximum severity)
[ Time Frame: Day 2 to Day 14 ]
Severity of gastrointestinal intolerance symptoms
Time Frame: [ Time Frame: Day 1 and Day 15 ]
Gastrointestinal Symptom Rating Scale, each visit will asses symptoms over the past 7 days
[ Time Frame: Day 1 and Day 15 ]
Change in stool frequency
Time Frame: [ Time Frame: Day 1 to Day 15 ]
Assessed by a questionnaire for stool frequency
[ Time Frame: Day 1 to Day 15 ]
Change in weight
Time Frame: [ Time Frame: Day 1 and Day 15 ]
[ Time Frame: Day 1 and Day 15 ]
Change in triglycerides
Time Frame: [ Time Frame: Day 1 and Day 15 ]
[ Time Frame: Day 1 and Day 15 ]
Change in cholesterol
Time Frame: [ Time Frame: Day 1 and Day 15 ]
[ Time Frame: Day 1 and Day 15 ]
Change in fatty acids profile
Time Frame: [ Time Frame: Day 1 and Day 15 ]
[ Time Frame: Day 1 and Day 15 ]
Changes full blood count
Time Frame: [ Time Frame: Day 1 and Day 15 ]
Number of participants with changes in haematology measurements (erythrocyte count, thrombocyte count, haemoglobin, haematocrit, mean cell hemoglobin concertation) using immunoassays.
[ Time Frame: Day 1 and Day 15 ]
Changes liver function
Time Frame: [ Time Frame: Day 1 and Day 15 ]
Number of participants with changes in liver function measurements (AST, ALT, ALP, GGT, albumin) using immunoassays
[ Time Frame: Day 1 and Day 15 ]
Changes in renal function
Time Frame: [ Time Frame: Day 1 and Day 15 ]
Number of participants with changes in renal function measurements (urea, creatinine) using immunoassays
[ Time Frame: Day 1 and Day 15 ]
Changes in blood glucose
Time Frame: [ Time Frame: Day 1 and Day 15 ]
[ Time Frame: Day 1 and Day 15 ]
Daily intake of study product
Time Frame: [ Time Frame: Day 1 to Day 15 ]
Number of subjects adhering to daily intake of the study product from baseline to Day 15, assessed by a daily questionnaire
[ Time Frame: Day 1 to Day 15 ]
Change in stool consistency
Time Frame: [ Time Frame: Day 1 to Day 15 ]
Assessed by the Bristol Stool Scale
[ Time Frame: Day 1 to Day 15 ]
Change in BMI
Time Frame: [ Time Frame: Day 1 and Day 15 ]
[ Time Frame: Day 1 and Day 15 ]
Change in Fat soluble-vitamins profile
Time Frame: [ Time Frame: Day 1 and Day 15 ]
Fat soluble-vitamins (A, D, E, K)
[ Time Frame: Day 1 and Day 15 ]
Change in serum biochemistry parameters
Time Frame: [ Time Frame: Day 1 and Day 15 ]
Number of participants with changes in serum biochemistry (triglycerides, total protein, bilirubin total, bilirubin direct, sodium, potassium, calcium, phosphate, magnesium, chloride, CRP) using immunoassays
[ Time Frame: 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)

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 24, 2021

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.
October 15, 2021

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.
October 15, 2021

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).
August 16, 2021

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.
October 20, 2021

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.
October 29, 2021

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.
April 5, 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.
March 31, 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, 2022

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.
  • 2104CLI

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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings