Ignite Creation Date:
2024-05-06 @ 3:28 PM
Last Modification Date:
2024-10-26 @ 1:50 PM
Study NCT ID:
NCT04646382
Status:
COMPLETED
Last Update Posted:
2023-02-23
First Post:
2020-10-22
Brief Title:
Effect of a Mixture of Allium Extracts on LDL Cholesterol Levels Volunteers With Elevated LDL Cholesterol Levels
Sponsor:
DOMCA SA
Organization:
DOMCA SA
Study Overview
Official Title:
Evaluation of the Effect of Consuming a Mixture of Concentrated Allium Extracts on LDL Cholesterol Levels in Healthy Volunteers With Elevated LDL Cholesterol Levels
Status:
COMPLETED
Status Verified Date:
2021-11
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:
To evaluate the efficacy of daily consumption of a combination of concentrated extracts of garlic Allium sativum L and onion Allium cepa L on LDL cholesterol levels in healthy volunteers Parameters related to metabolic syndrome cardiovascular health and the immune system will also be analyzed
Detailed Description:
It is a controlled randomized double-blind parallel-group nutritional intervention study
64 healthy volunteers lwith elevated LDL cholesterol levels but who do not require pharmacological treatment will be randomly distributed into 2 equal groups control group and intervention group
For 8 weeks the volunteers will take the product immediately after lunch During that time they will maintain their lifestyle and nutritional habits
Blood samples will be taken at 0 2 4 and 8 weeks Anthropometric parameters and health-related data were also measured
Parameters related to lipid metabolism metabolic syndrome and the immune system will be analized
64 healthy volunteers lwith elevated LDL cholesterol levels but who do not require pharmacological treatment will be randomly distributed into 2 equal groups control group and intervention group
For 8 weeks the volunteers will take the product immediately after lunch During that time they will maintain their lifestyle and nutritional habits
Blood samples will be taken at 0 2 4 and 8 weeks Anthropometric parameters and health-related data were also measured
Parameters related to lipid metabolism metabolic syndrome and the immune system will be analized
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