Clinical trial NCT03825042: Effect of an Antioxidants Mix on Cognitive Performance and Well Being: The Bacopa, Licopene, Astaxantina, Vitamin B12
Official title: Effect of an Antioxidants Mix on Cognitive Performance and Well Being: The Bacopa, Licopene, Astaxantina, Vitamin B12
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognitive Dysfunction
Lead sponsor: A. Menarini Industrie Farmaceutiche Riunite S.r.l.
Sponsor class: INDUSTRY
First posted: 2019-01-31
Enrollment: 80
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 9-weeks double-blind, randomized, placebo-controlled, parallel-arm superiority study
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: Inclusion Criteria:

1. Subjects aged ≥60 years.
2. Subjects who provide written Informed Consent to the study.

Exclusion Criteria:

1. Subjects with cognitive dysfunctions or clinically significant coexisting medical conditions (cardiovascular disease, cerebrovascular events, overt dementia defined by MMSE \<27 or other neurological disorders, thyroid disorders, or inflammatory diseases)
2. Subjects with a score on the Geriatric Depression Scale (GDS) \>11 in order to avoid confounding due to the influence of concomitant depression on the performance on cognitive tests
3. Current smokers
4. Habitual users of antioxidant supplements (including vitamins C and E)
5. Habitual consumers of chocolate or other cocoa products (daily consumption of any amount)
6. Subjects under treatments with medications known to have antioxidant properties (including statins and glitazones) or to interfere with cognitive functions (including benzodiazepines and antidepressants)
7. Subjects with hypersensitivity to any component of the study medications
8. Subjects who are participating in or having participated in another clinical trial within the previous three months.

Primary outcomes:
measure: Change in Trail Making Test (TMT) B Between Baseline and End of Treatment
timeFrame: 8 weeks - from baseline to end of study
measure: Change Trail Making Test (TMT) A Between Baseline and End of Treatment
timeFrame: 8 weeks - from baseline to end of study
measure: Change in Trail Making Test (TMT) B - Trail Making Test (TMT) A Between Baseline and End of Treatment
timeFrame: 8 weeks - from baseline to end of study
Secondary outcomes:
Other outcomes:
Locations:
city: Avezzano
country: Italy
facility: U.O.C. Geriatria e Lungodegenza - P.O. SS Filippo e Nicola di Avezzano
state: L'Aquila
Study officials:
affiliation: U.O.C. Geriatria e Lungodegenza - P.O. SS Filippo e Nicola di Avezzano
name: Giovambattista GD Desideri
role: PRINCIPAL_INVESTIGATOR
References: