Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 1:23 AM
Ignite Modification Date:
2025-12-25 @ 1:23 AM
NCT ID:
NCT05923593
Brief Summary:
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:
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
Study:
NCT05923593
Study Brief:
Protocol Section:
NCT05923593