Healthy VolunteersNCT05923593
Tolerance and Safety of an Oral Nutritional Supplement (Adolescent Cohort)
A study testing MAG oil oral nutritional supplement (ONS) in people with Healthy Volunteers, run by Société des Produits Nestlé (SPN) at 1 site in Switzerland.
Trial summary
This is an open label, non-randomized, interventional, single arm study. Read more about this study
- Who is it for?
- Ages 12 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- MAG oil oral nutritional supplement (ONS)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteSwitzerland
- Study dates
- 20 Mar 2023to 30 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy volunteers aged 12-17 years
- BMI range between the 10th and 90th percentile according to the Swiss growth charts with a minimum body weight of 40 kg.
- Deemed able to comply with study protocol for the study period
- Able to obtain written informed consent from participants and legally authorized representative(s)
Who cannot join
- Pre-existing chronic medical or psychiatric conditions.
- 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.
- Recent episode of an acute gastrointestinal illness with significant gastrointestinal symptoms in the 7 days prior to enrolment.
- 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.
- Colonoscopy or other bowel cleansing procedures within 4 weeks prior to enrolment.
- 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.
Show all 13Show fewer
- Significant medical or surgical event in the past 3 months potentially interfering with study procedures and assessments.
- Subjects following a weight loss program including a low-carbohydrate or low-fat diet, ketogenic diet, intermittent fasting, or any other special diet.
- 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.
- Subjects taking energy or protein supplements.
- Known alcohol or substance abuse.
- 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.
- Family or hierarchical relationships with Clinical Innovation Lab staff
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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:
- Describe the frequency and characteristics of possible gastrointestinal intolerance symptoms
- Describe stool characteristics specifically stool frequency and consistency
- Describe changes in anthropometric parameters, particularly weight and body mass index (BMI)
- Describe changes in blood parameters of lipid metabolism
- Describe changes in hematological and serum biochemistry parameters
- Describe daily ONS intake and overall compliance
- Conditions
- Healthy Volunteers
- Being tested
- MAG oil oral nutritional supplement (ONS)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MAG oil oral nutritional supplement (ONS)Dietary supplement
The study product is suitable for use as an oral nutritional supplement (ONS).The study product contains MAG oil.
| Study group | Role | What they receive |
|---|---|---|
| Oral nutritional supplement | Experimental | Oral nutritional supplement that contains MAG oil Receives: Dietary Supplement: MAG oil oral nutritional supplement (ONS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Number of subjects who develop significant gastrointestinal adverse events leading to discontinuation of the study product and withdrawal from the study
Measured: Day 2 to Day 15
Secondary outcomes (34)
Severity of gastrointestinal intolerance symptoms
Individual gastrointestinal symptom scores assessed by the Visual Analogue Scale (VAS) tool from 0 (no symptom) to 10 (maximum severity)
Measured: Day 1 to Day 15
Severity of gastrointestinal intolerance symptoms
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)
Measured: Day 1 and Day 15
Change in stool frequency
Assessed by a questionnaire on daily number of stools
Measured: Day 1 to Day 15
Change in stool consistency
Assessed by Bristol Stool Scale from stool consistency A (Separate hard lumps, like nuts, hard to pass) to G (Watery, no solid pieces)
Measured: Day 1 to Day 15
Change in weight
Measured with a weight scale
Measured: Day 1 and Day 15
Change in BMI
Measured with a weight scale and size scale
Measured: Day 1 and Day 15
Changes in lipid profile in the blood
Triglycerides, cholesterol (total cholesterol, LDL cholesterol and HDL cholesterol) measured in plasma
Measured: Day 1 and Day 15
Changes in liver function tests in the blood
ALAT measured in plasma
Measured: Day 1 and Day 15
Changes in liver function tests in the blood
ASAT measured in plasma
Measured: Day 1 and Day 15
Changes in liver function tests in the blood
phosphatase alkaline measured in plasma
Measured: Day 1 and Day 15
Changes in liver function tests in the blood
Gamma glutamyl transferase measured in plasma
Measured: Day 1 and Day 15
Changes in liver function tests in the blood
Total and direct bilirubin measured in plasma
Measured: Day 1 and Day 15
Changes in liver function tests in the blood
Protein and albumin measured in plasma
Measured: Day 1 and Day 15
Changes in renal function tests in the blood
Urea, creatinine measured in plasma
Measured: Day 1 and Day 15
Changes in blood chemistry tests
C-Reactive Protein measured in serum
Measured: Day 1 and Day 15
Changes in blood chemistry tests
Glucose measured in serum
Measured: Day 1 and Day 15
Changes in blood chemistry tests
Sodium measured in serum
Measured: Day 1 and Day 15
Changes in blood chemistry tests
Potassium measured in serum
Measured: Day 1 and Day 15
Changes in blood chemistry tests
Calcium measured in serum
Measured: Day 1 and Day 15
Changes in blood chemistry tests
Phosphate measured in serum
Measured: Day 1 and Day 15
Changes in blood chemistry tests
Magnesium measured in serum
Measured: Day 1 and Day 15
Changes in blood chemistry tests
Chloride measured in serum
Measured: Day 1 and Day 15
Daily intake of study product
Number of participants adhering to daily intake of the study product assessed by a daily questionnaire
Measured: Day 1 to Day 15
Changes in full blood count
thrombocyte count
Measured: Day 1 and Day 15
Changes in full blood count
Erythrocyte count
Measured: Day 1 and Day 15
Changes in full blood count
haemoglobin measured in blood
Measured: Day 1 and Day 15
Changes in full blood count
haematocrit measured in blood
Measured: Day 1 and Day 15
Changes in full blood count
mean cell hemoglobin concentation measured in Blood
Measured: Day 1 and Day 15
Changes in fatty acids profile
Plasma and erythrocytes fatty acids profile
Measured: Day 1 and Day 15
Change in Vitamin A level
Change in serum Vitamin A
Measured: Day 1 and Day 15
Change in 25-hydroxy vitamin D level
Change in serum 25-hydroxy vitamin D
Measured: Day 1 and Day 15
Change in vitamin E level
Change in serum vitamin E
Measured: Day 1 and Day 15
Changes in Vitamin K level
change in international normalized ratio
Measured: Day 1 and Day 15
Changes in in fat-soluble vitamins
Vitamin E/cholesterol ratio measured in plasma
Measured: Day 1 and Day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2023
- Study start20 Mar 2023
- Primary completion15 Jun 2023
- Study completion30 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by Société des Produits Nestlé (SPN)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pamela Sun, Principal investigator, Neslté
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05923593
- Sponsor's protocol ID
- 2214NR
- Status last verified
- Oct 2023
- First submitted
- 27 Feb 2023
- Last updated
- 18 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Zemrani B, Krattinger LF, Giuffrida F, Corthesy J, Ran-Ressler RR, Benyacoub J. Safety and tolerability of Monoacylglycerol-rich oil as a novel predigested dietary fat source of an enteral formula in healthy adults and adolescents: Two single-arm, open-label studies. Clin Nutr ESPEN. 2025 Feb;65:339-347. doi: 10.1016/j.clnesp.2024.12.014. Epub 2024 Dec 15.
PubMed 39681164
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tolerance and Safety of an Oral Nutritional Supplement Containing Monoacylglycerol Oil (MAG Oil) as the Main Lipid Source in Healthy Adolescents
- ClinicalTrials.gov ID
- NCT05923593
- Acronym / sponsor ID
- 2214NR
- Conditions
- Healthy Volunteers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- 20 Mar 2023 (actual)
- Primary completion
- 15 Jun 2023 (actual)
- Study completion
- 30 Aug 2023 (actual)
- First posted
- 28 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an open label, non-randomized, interventional, single arm study.
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:
- Describe the frequency and characteristics of possible gastrointestinal intolerance symptoms
- Describe stool characteristics specifically stool frequency and consistency
- Describe changes in anthropometric parameters, particularly weight and body mass index (BMI)
- Describe changes in blood parameters of lipid metabolism
- Describe changes in hematological and serum biochemistry parameters
- Describe daily ONS intake and overall compliance
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Oral nutritional supplement | Experimental | Dietary Supplement: MAG oil oral nutritional supplement (ONS)Oral nutritional supplement that contains MAG oil |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Healthy volunteers aged 12-17 years
- BMI range between the 10th and 90th percentile according to the Swiss growth charts with a minimum body weight of 40 kg.
- Deemed able to comply with study protocol for the study period
- Able to obtain written informed consent from participants and legally authorized representative(s)
Key exclusion criteria (13 listed)
- Pre-existing chronic medical or psychiatric conditions.
- 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.
- Recent episode of an acute gastrointestinal illness with significant gastrointestinal symptoms in the 7 days prior to enrolment.
- 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.
- Colonoscopy or other bowel cleansing procedures within 4 weeks prior to enrolment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Dietary supplement | Oral nutritional supplement |
Primary outcome
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
34 secondary outcomes
Severity of gastrointestinal intolerance symptoms
Time frame: Day 1 to Day 15
Severity of gastrointestinal intolerance symptoms
Time frame: Day 1 and Day 15
Change in stool frequency
Time frame: Day 1 to Day 15
Change in stool consistency
Time frame: Day 1 to Day 15
Change in weight
Time frame: Day 1 and Day 15
Change in BMI
Time frame: Day 1 and Day 15
Changes in lipid profile in the blood
Time frame: Day 1 and Day 15
Changes in liver function tests in the blood
Time frame: Day 1 and Day 15
Changes in liver function tests in the blood
Time frame: Day 1 and Day 15
Changes in liver function tests in the blood
Time frame: Day 1 and Day 15
Changes in liver function tests in the blood
Time frame: Day 1 and Day 15
Changes in liver function tests in the blood
Time frame: Day 1 and Day 15
Changes in liver function tests in the blood
Time frame: Day 1 and Day 15
Changes in renal function tests in the blood
Time frame: Day 1 and Day 15
Changes in blood chemistry tests
Time frame: Day 1 and Day 15
Changes in blood chemistry tests
Time frame: Day 1 and Day 15
Changes in blood chemistry tests
Time frame: Day 1 and Day 15
Changes in blood chemistry tests
Time frame: Day 1 and Day 15
Changes in blood chemistry tests
Time frame: Day 1 and Day 15
Changes in blood chemistry tests
Time frame: Day 1 and Day 15
Changes in blood chemistry tests
Time frame: Day 1 and Day 15
Changes in blood chemistry tests
Time frame: Day 1 and Day 15
Daily intake of study product
Time frame: Day 1 to Day 15
Changes in full blood count
Time frame: Day 1 and Day 15
Changes in full blood count
Time frame: Day 1 and Day 15
Changes in full blood count
Time frame: Day 1 and Day 15
Changes in full blood count
Time frame: Day 1 and Day 15
Changes in full blood count
Time frame: Day 1 and Day 15
Changes in fatty acids profile
Time frame: Day 1 and Day 15
Change in Vitamin A level
Time frame: Day 1 and Day 15
Change in 25-hydroxy vitamin D level
Time frame: Day 1 and Day 15
Change in vitamin E level
Time frame: Day 1 and Day 15
Changes in Vitamin K level
Time frame: Day 1 and Day 15
Changes in in fat-soluble vitamins
Time frame: Day 1 and Day 15
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2023.
- Derived from this study: PubMed 39681164Zemrani B, Krattinger LF, Giuffrida F, Corthesy J, Ran-Ressler RR, Benyacoub J. Safety and tolerability of Monoacylglycerol-rich oil as a novel predigested dietary fat source of an enteral formula in healthy adults and adolescents: Two single-arm, open-label studies. Clin Nutr ESPEN. 2025 Feb;65:339-347. doi: 10.1016/j.clnesp.2024.12.014. Epub 2024 Dec 15.
- Individual participant dataSharing planned: Undecided
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Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pamela Sun principal investigator
Neslté
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MAG oil oral nutritional supplement (ONS) in people with Healthy Volunteers, run by Société des Produits Nestlé (SPN) at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05923593, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2023.