N/A
N=80
Effect of an Antioxidants Mix on Cognitive Performance and Well Being: The Bacopa, Licopene, Astaxantina, Vitamin B12
Cognitive Dysfunction
Bottom Line
View on ClinicalTrials.gov: NCT03825042 ↗Enrolled (actual)
80
Serious AEs
1.3%
Results posted
Jul 2020
Primary outcome: Primary: Change in Trail Making Test (TMT) B Between Baseline and End of Treatment — -17.63; 3.46 seconds — p=0.0000
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- A mix of bioactive natural compounds (Dietary_supplement); Placebo (Dietary_supplement)
- Age
- Adult, Older Adult · 60+ yrs
- Sex
- All
- Sponsor
- A. Menarini Industrie Farmaceutiche Riunite S.r.l.
- Primary completion
- Oct 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Trail Making Test (TMT) B Between Baseline and End of Treatment |
-17.63; 3.46 | 0.0000 sig |
| PRIMARY Change Trail Making Test (TMT) A Between Baseline and End of Treatment |
-6.86; -0.37 | 0.0000 sig |
| PRIMARY Change in Trail Making Test (TMT) B - Trail Making Test (TMT) A Between Baseline and End of Treatment |
-10.46; 3.84 | 0.0000 sig |
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.
Eligibility Criteria
Inclusion Criteria
- Subjects aged ≥60 years.
- Subjects who provide written Informed Consent to the study.
Exclusion Criteria
- Subjects with cognitive dysfunctions or clinically significant coexisting medical conditions (cardiovascular disease, cerebrovascular events, overt dementia defined by MMSE 11 in order to avoid confounding due to the influence of concomitant depression on the performance on cognitive tests
- Current smokers
- Habitual users of antioxidant supplements (including vitamins C and E)
- Habitual consumers of chocolate or other cocoa products (daily consumption of any amount)
- Subjects under treatments with medications known to have antioxidant properties (including statins and glitazones) or to interfere with cognitive functions (including benzodiazepines and antidepressants)
- Subjects with hypersensitivity to any component of the study medications
- Subjects who are participating in or having participated in another clinical trial within the previous three months.
Data sourced from ClinicalTrials.gov (NCT03825042). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.