Effect of an Antioxidants Mix on Cognitive Performance and Well Being: The Bacopa, Licopene, Astaxantina, Vitamin B12 (BLAtwelve)
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
L'Aquila
-
Avezzano, L'Aquila, Italy, 67051
- U.O.C. Geriatria e Lungodegenza - P.O. SS Filippo e Nicola di Avezzano
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 <27 or other neurological disorders, thyroid disorders, or inflammatory diseases)
- 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
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Food supplement
A mix of bacopa, lycopene, astaxanthin and vitamin B12 Dosage form: tablets Dosage: 1 tablet/die Duration: 8 weeks
|
A mix of bacopa, lycopene, astaxanthin and vitamin B12 in oral tablets
|
|
PLACEBO_COMPARATOR: Placebo
Inactive compound Dosage form: tablets Dosage: 1 tablet/die Duration: 8 weeks
|
Inactive compound in oral tablets
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Trail Making Test (TMT) B Between Baseline and End of Treatment
Time Frame: 8 weeks - from baseline to end of study
|
Change in Trail Making Test (TMT) B scores from baseline (V2) to 8 weeks of treatment (V4). The reduction in the number of seconds the patients take to make the test after the study treatment means an improvement in cognitive functions. |
8 weeks - from baseline to end of study
|
|
Change Trail Making Test (TMT) A Between Baseline and End of Treatment
Time Frame: 8 weeks - from baseline to end of study
|
Change in Trail Making Test (TMT) A scores from baseline (V2) to 8 weeks of treatment (V4). The reduction in the number of seconds the patients take to make the test after the study treatment means an improvement in cognitive functions. |
8 weeks - from baseline to end of study
|
|
Change in Trail Making Test (TMT) B - Trail Making Test (TMT) A Between Baseline and End of Treatment
Time Frame: 8 weeks - from baseline to end of study
|
Change in Trail Making Test (TMT) B score minus Trail Making Test (TMT) A score from baseline (V2) to 8 weeks of treatment (V4). The reduction in the number of seconds the patients take to make the test after the study treatment means an improvement in cognitive functions. |
8 weeks - from baseline to end of study
|
Collaborators and Investigators
Investigators
- Principal Investigator: Giovambattista GD Desideri, U.O.C. Geriatria e Lungodegenza - P.O. SS Filippo e Nicola di Avezzano
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MEIF/17/BAC-COG/001
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.