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Adolescent cohort will be conducted as separate trial
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This is an open label, non-randomized, interventional, single arm study.
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:
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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, hydrolyzed whey protein, simple carbohydrates, vitamins and minerals. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects who develop gastrointestinal intolerance leading to premature discontinuation | 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 ] |
| Measure | Description | Time Frame |
|---|---|---|
| Severity of gastrointestinal intolerance symptoms | Visual analog scale from 0 (no symptom) to 10 (maximum severity) | [ Time Frame: Day 2 to Day 14 ] |
| Severity of gastrointestinal intolerance symptoms |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nestlé CDU / Clinical Innovation Lab | Lausanne | 1000 | 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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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 | Assessed by a questionnaire for stool frequency | [ Time Frame: Day 1 to Day 15 ] |
| Change in weight | [ Time Frame: Day 1 and Day 15 ] |
| Change in triglycerides | [ Time Frame: Day 1 and Day 15 ] |
| Change in cholesterol | [ Time Frame: Day 1 and Day 15 ] |
| Change in fatty acids profile | [ Time Frame: Day 1 and Day 15 ] |
| Changes full blood count | 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 | 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 | 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: Day 1 and Day 15 ] |
| Daily intake of study product | 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 | Assessed by the Bristol Stool Scale | [ Time Frame: Day 1 to Day 15 ] |
| Change in BMI | [ Time Frame: Day 1 and Day 15 ] |
| Change in Fat soluble-vitamins profile | Fat soluble-vitamins (A, D, E, K) | [ Time Frame: Day 1 and Day 15 ] |
| Change in serum biochemistry parameters | 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 ] |