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

NCT03825042 | Completed Results

• 1 other identifier: MEIF/17/BAC-COG/001
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Cognitive Dysfunction

Outcome Measures

Primary Outcomes (3)

• Change in Trail Making Test (TMT) B Between Baseline and End of Treatment

  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

  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

  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

Study Arms (2)

Food supplement

EXPERIMENTAL

A mix of bacopa, lycopene, astaxanthin and vitamin B12 Dosage form: tablets Dosage: 1 tablet/die Duration: 8 weeks

Dietary Supplement: A mix of bioactive natural compounds

Placebo

PLACEBO COMPARATOR

Inactive compound Dosage form: tablets Dosage: 1 tablet/die Duration: 8 weeks

Dietary Supplement: Placebo

Interventions

A mix of bioactive natural compounds DIETARY_SUPPLEMENT

A mix of bacopa, lycopene, astaxanthin and vitamin B12 in oral tablets

Food supplement

Placebo DIETARY_SUPPLEMENT

Inactive compound in oral tablets

Placebo

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• A. Menarini Industrie Farmaceutiche Riunite S.r.l.: lead

Study Sites (1)

U.O.C. Geriatria e Lungodegenza - P.O. SS Filippo e Nicola di Avezzano

Avezzano, L'Aquila, 67051, Italy

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Results Point of Contact

• Title: Director of Clinical Operations
• Organization: A.Menarini Industrie Farmaceutiche Riunite Srl

pfabrizzi@menarini.it

0039 055 5680459

Study Officials

• Giovambattista GD Desideri

  U.O.C. Geriatria e Lungodegenza - P.O. SS Filippo e Nicola di Avezzano

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The study treatment was assigned through envelopes randomization system: the site was provided with sealed envelopes, numbered in progressive number starting from R-001, containing the treatment kit to be assigned to the subject. The Investigator will open the first available envelope in progressive order. Inside the envelope there will be the kit number of the treatment to be assigned to that subject.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 9-weeks double-blind, randomized, placebo-controlled, parallel-arm superiority study

Study Record Dates

• First Submitted: January 30, 2019
• First Posted: January 31, 2019
• Study Start: January 23, 2018
• Primary Completion: October 29, 2018
• Study Completion: October 29, 2018
• Last Updated: July 27, 2020
• Results First Posted: July 27, 2020

Record last verified: 2019-02

Locations

IT (1)