NCT05923593

Tolerance and Safety of an Oral Nutritional Supplement (Adolescent Cohort)

Tolerance and Safety of an Oral Nutritional Supplement Containing Monoacylglycerol Oil (MAG Oil) as the Main Lipid Source in Healthy Adolescents

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Société des Produits Nestlé (SPN) · Industry
• Sex: All
• Age: 12 Years – 17 Years
• Healthy volunteers: Accepted

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

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	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.

Timeline

• Start date: 2023-03-20
• Primary completion: 2023-06-15
• Completion: 2023-08-30
• First posted: 2023-06-28
• Last updated: 2023-10-18

Locations

1 site across 1 country: Switzerland