NCT05100901

Tolerance and Safety of an Oral Nutritional Supplement

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

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

Summary

This is an open label, non-randomized, interventional, single arm study.

Detailed description

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: 1. Describe the incidence and characteristics of possible gastrointestinal intolerance symptoms 2. Describe changes in 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 assess dietary adherence to the study protocol

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, hydrolyzed whey protein, simple carbohydrates, vitamins and minerals.

Timeline

• Start date: 2021-09-24
• Primary completion: 2021-10-15
• Completion: 2021-10-15
• First posted: 2021-10-29
• Last updated: 2023-04-05

Locations

1 site across 1 country: Switzerland