Ignite Creation Date:
2025-12-25 @ 1:23 AM
Ignite Modification Date:
2026-01-03 @ 2:24 PM
Study NCT ID:
NCT05923593
Status:
COMPLETED
Last Update Posted:
2023-10-18
First Post:
2023-02-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tolerance and Safety of an Oral Nutritional Supplement (Adolescent Cohort)
Sponsor:
Société des Produits Nestlé (SPN)
Organization:
Study Overview
Official Title:
Tolerance and Safety of an Oral Nutritional Supplement Containing Monoacylglycerol Oil (MAG Oil) as the Main Lipid Source in Healthy Adolescents
Status:
COMPLETED
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: