Healthy Volunteers Clinical Trial
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.
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 ;
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