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This is an open label, non-randomized, interventional, single arm study.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral nutritional supplement | Experimental | Oral nutritional supplement that contains MAG oil |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| 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 | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Day 1 to Day 15 |
| Severity of gastrointestinal intolerance symptoms |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pamela Sun | Neslté | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Innovation Lab. | Lausanne | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39681164 | Derived | 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. |
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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 frequency | Assessed by a questionnaire on daily number of stools | 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) | Day 1 to Day 15 |
| Change in weight | Measured with a weight scale | Day 1 and Day 15 |
| Change in BMI | Measured with a weight scale and size scale | Day 1 and Day 15 |
| Changes in lipid profile in the blood | 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 | ALAT measured in plasma | Day 1 and Day 15 |
| Changes in liver function tests in the blood | ASAT measured in plasma | Day 1 and Day 15 |
| Changes in liver function tests in the blood | phosphatase alkaline measured in plasma | Day 1 and Day 15 |
| Changes in liver function tests in the blood | Gamma glutamyl transferase measured in plasma | Day 1 and Day 15 |
| Changes in liver function tests in the blood | Total and direct bilirubin measured in plasma | Day 1 and Day 15 |
| Changes in liver function tests in the blood | Protein and albumin measured in plasma | Day 1 and Day 15 |
| Changes in renal function tests in the blood | Urea, creatinine measured in plasma | Day 1 and Day 15 |
| Changes in blood chemistry tests | C-Reactive Protein measured in serum | Day 1 and Day 15 |
| Changes in blood chemistry tests | Glucose measured in serum | Day 1 and Day 15 |
| Changes in blood chemistry tests | Sodium measured in serum | Day 1 and Day 15 |
| Changes in blood chemistry tests | Potassium measured in serum | Day 1 and Day 15 |
| Changes in blood chemistry tests | Calcium measured in serum | Day 1 and Day 15 |
| Changes in blood chemistry tests | Phosphate measured in serum | Day 1 and Day 15 |
| Changes in blood chemistry tests | Magnesium measured in serum | Day 1 and Day 15 |
| Changes in blood chemistry tests | Chloride measured in serum | 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 | Day 1 to Day 15 |
| Changes in full blood count | thrombocyte count | Day 1 and Day 15 |
| Changes in full blood count | Erythrocyte count | Day 1 and Day 15 |
| Changes in full blood count | haemoglobin measured in blood | Day 1 and Day 15 |
| Changes in full blood count | haematocrit measured in blood | Day 1 and Day 15 |
| Changes in full blood count | mean cell hemoglobin concentation measured in Blood | Day 1 and Day 15 |
| Changes in fatty acids profile | Plasma and erythrocytes fatty acids profile | Day 1 and Day 15 |
| Change in Vitamin A level | Change in serum Vitamin A | Day 1 and Day 15 |
| Change in 25-hydroxy vitamin D level | Change in serum 25-hydroxy vitamin D | Day 1 and Day 15 |
| Change in vitamin E level | Change in serum vitamin E | Day 1 and Day 15 |
| Changes in Vitamin K level | change in international normalized ratio | Day 1 and Day 15 |
| Changes in in fat-soluble vitamins | Vitamin E/cholesterol ratio measured in plasma | Day 1 and Day 15 |