Ignite Creation Date:
2024-05-06 @ 12:42 PM
Last Modification Date:
2024-10-26 @ 1:02 PM
Study NCT ID:
NCT03825042
Status:
COMPLETED
Last Update Posted:
2020-07-27
First Post:
2019-01-30
Brief Title:
Effect of an Antioxidants Mix on Cognitive Performance and Well Being The Bacopa Licopene Astaxantina Vitamin B12
Sponsor:
A Menarini Industrie Farmaceutiche Riunite Srl
Organization:
A Menarini Industrie Farmaceutiche Riunite Srl
Study Overview
Official Title:
Effect of an Antioxidants Mix on Cognitive Performance and Well Being The Bacopa Licopene Astaxantina Vitamin B12
Status:
COMPLETED
Status Verified Date:
2019-02
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:
BLAtwelve
Brief Summary:
Nine-weeks double-blind randomized placebo-controlled parallel-arm superiority study
The aim of this study is to evaluate the influence of a mix of four bioactive compounds - bacopa lycopene astaxanthin and vitamin B12 - on cognitive performance mood state and well-being in subjects aged 60 years with no evidence of cognitive dysfunction
The primary objective of the study is to evaluate the changes in Trial Making Test TMT scores from baseline V2 to 8 weeks of treatment V4 analyzed in the following hierarchical order TMT-B TMT-A and TMT B-A
Secondary objectives of this study are to evaluate changes from baseline V2 to 8 weeks of treatment V4 in Verbal Fluency Test VFT score Montreal Cognitive Assessment MoCA score Mini Mental State Examination MMSE score Rey Auditory Verbal Learning Test AVLT psychological well-being as assessed by General Health Questionnaire GHQ-12 mood states as assessed by the Profile of Mood Stated POMS sexual satisfaction as evaluated by the New Sexual Satisfaction Scale NSSS
Changes of metabolic parameters from baseline V2 to 4 weeks of treatment V3 and from baseline V2 to 8 weeks of treatment V4 will be also evaluated as secondary objectives glucose insulin Homeostatic Model Assessment for Insulin Resistance HOMA-IR total cholesterol LDL cholesterol HDL cholesterol triglycerides uric acid
Changes of plasma markers of oxidative stress from baseline V2 to 4 weeks of treatment V3 and from baseline V2 to 8 weeks of treatment V4 will be evaluated as secondary objectives 8-iso-Prostaglandin F2alpha Plasma malondialdehyde
Finally the safety and tolerability of the study product will be assessed
The aim of this study is to evaluate the influence of a mix of four bioactive compounds - bacopa lycopene astaxanthin and vitamin B12 - on cognitive performance mood state and well-being in subjects aged 60 years with no evidence of cognitive dysfunction
The primary objective of the study is to evaluate the changes in Trial Making Test TMT scores from baseline V2 to 8 weeks of treatment V4 analyzed in the following hierarchical order TMT-B TMT-A and TMT B-A
Secondary objectives of this study are to evaluate changes from baseline V2 to 8 weeks of treatment V4 in Verbal Fluency Test VFT score Montreal Cognitive Assessment MoCA score Mini Mental State Examination MMSE score Rey Auditory Verbal Learning Test AVLT psychological well-being as assessed by General Health Questionnaire GHQ-12 mood states as assessed by the Profile of Mood Stated POMS sexual satisfaction as evaluated by the New Sexual Satisfaction Scale NSSS
Changes of metabolic parameters from baseline V2 to 4 weeks of treatment V3 and from baseline V2 to 8 weeks of treatment V4 will be also evaluated as secondary objectives glucose insulin Homeostatic Model Assessment for Insulin Resistance HOMA-IR total cholesterol LDL cholesterol HDL cholesterol triglycerides uric acid
Changes of plasma markers of oxidative stress from baseline V2 to 4 weeks of treatment V3 and from baseline V2 to 8 weeks of treatment V4 will be evaluated as secondary objectives 8-iso-Prostaglandin F2alpha Plasma malondialdehyde
Finally the safety and tolerability of the study product will be assessed
Detailed Description:
The study has been conducted in 1 Italian clinical site and involved 80 subjects
Subjects will be randomly allocated to one of the following groups
Group I mix of the four bioactive compounds bacopa lycopene astaxanthin and vitamin B12 once a day for 8 weeks per os
Group II placebo once a day for 8 weeks per os
The study is double blind Neither the study staff at clinical sites Investigators nurses pharmacist nor the subject was aware of the treatment assigned
Each participant attended 4 visits over a total period of about 9 weeks
Subjects will be randomly allocated to one of the following groups
Group I mix of the four bioactive compounds bacopa lycopene astaxanthin and vitamin B12 once a day for 8 weeks per os
Group II placebo once a day for 8 weeks per os
The study is double blind Neither the study staff at clinical sites Investigators nurses pharmacist nor the subject was aware of the treatment assigned
Each participant attended 4 visits over a total period of about 9 weeks
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