Ignite Creation Date:
2024-05-06 @ 4:50 PM
Last Modification Date:
2024-10-26 @ 2:16 PM
Study NCT ID:
NCT05100901
Status:
TERMINATED
Last Update Posted:
2023-04-05
First Post:
2021-08-16
Brief Title:
Tolerance and Safety of an Oral Nutritional Supplement
Sponsor:
Société des Produits Nestlé SPN
Organization:
Société des Produits Nestlé SPN
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 and Adults
Status:
TERMINATED
Status Verified Date:
2022-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Adolescent cohort will be conducted as separate trial
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:
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
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
Study Oversight
Has Oversight DMC:
None
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?:
None