NCT03825042

Effect of an Antioxidants Mix on Cognitive Performance and Well Being: The Bacopa, Licopene, Astaxantina, Vitamin B12

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: A. Menarini Industrie Farmaceutiche Riunite S.r.l. · Industry
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Cognitive Dysfunction

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	A mix of bioactive natural compounds	A mix of bacopa, lycopene, astaxanthin and vitamin B12 in oral tablets
DIETARY_SUPPLEMENT	Placebo	Inactive compound in oral tablets

Timeline

• Start date: 2018-01-23
• Primary completion: 2018-10-29
• Completion: 2018-10-29
• First posted: 2019-01-31
• Last updated: 2020-07-27
• Results posted: 2020-07-27

Locations

1 site across 1 country: Italy