Trial Outcomes & Findings for Effect of an Antioxidants Mix on Cognitive Performance and Well Being: The Bacopa, Licopene, Astaxantina, Vitamin B12 (NCT NCT03825042)

Last Updated: 2020-07-27

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

80 participants

Primary outcome timeframe

8 weeks - from baseline to end of study

Results posted on

2020-07-27

Participant Flow

The recruitment period started on January 2018 and terminated on October 2018. A total of 80 subjetcs have been randomization and 78 completed the study. Each subject has been involved in the study for approximately two months. A total of 4 study visits has been performed for each subject.

Subjects who provided written informed consent have been subjected to the screening assessments. Subjects who met all inclusion criteria and none of the exclusion criteria have been eligible for the study and have proceeded with the randomization visit after 7 days. No wash-out or run-in period was used in this study. 8

Participant milestones

Participant milestones
Measure	Food Supplement A mix of bacopa, lycopene, astaxanthin and vitamin B12 Dosage form: tablets Dosage: 1 tablet per day Duration: 8 weeks A mix of bioactive natural compounds: A mix of bacopa, lycopene, astaxanthin and vitamin B12 in oral tablets	Placebo Inactive compound Dosage form: tablets Dosage: 1 tablet per day Duration: 8 weeks Placebo: Inactive compound in oral tablets
Overall Study STARTED	40	40
Overall Study COMPLETED	38	40
Overall Study NOT COMPLETED	2	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Food Supplement A mix of bacopa, lycopene, astaxanthin and vitamin B12 Dosage form: tablets Dosage: 1 tablet per day Duration: 8 weeks A mix of bioactive natural compounds: A mix of bacopa, lycopene, astaxanthin and vitamin B12 in oral tablets	Placebo Inactive compound Dosage form: tablets Dosage: 1 tablet per day Duration: 8 weeks Placebo: Inactive compound in oral tablets
Overall Study Adverse Event	1	0
Overall Study Withdrawal by Subject	1	0

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Food Supplement n=40 Participants A mix of bacopa, lycopene, astaxanthin and vitamin B12 Dosage form: tablets Dosage: 1 tablet per day Duration: 8 weeks A mix of bioactive natural compounds: A mix of bacopa, lycopene, astaxanthin and vitamin B12 in oral tablets	Placebo n=40 Participants Inactive compound Dosage form: tablets Dosage: 1 tablet per day Duration: 8 weeks Placebo: Inactive compound in oral tablets	Total n=80 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=113 Participants	0 Participants n=163 Participants	0 Participants n=160 Participants
Age, Categorical Between 18 and 65 years	37 Participants n=113 Participants	39 Participants n=163 Participants	76 Participants n=160 Participants
Age, Categorical >=65 years	3 Participants n=113 Participants	1 Participants n=163 Participants	4 Participants n=160 Participants
Age, Continuous	61.88 years STANDARD_DEVIATION 1.36 • n=113 Participants	62.05 years STANDARD_DEVIATION 1.55 • n=163 Participants	61.96 years STANDARD_DEVIATION 1.45 • n=160 Participants
Sex: Female, Male Female	28 Participants n=113 Participants	27 Participants n=163 Participants	55 Participants n=160 Participants
Sex: Female, Male Male	12 Participants n=113 Participants	13 Participants n=163 Participants	25 Participants n=160 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=113 Participants	0 Participants n=163 Participants	0 Participants n=160 Participants
Race (NIH/OMB) Asian	0 Participants n=113 Participants	0 Participants n=163 Participants	0 Participants n=160 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=113 Participants	0 Participants n=163 Participants	0 Participants n=160 Participants
Race (NIH/OMB) Black or African American	0 Participants n=113 Participants	0 Participants n=163 Participants	0 Participants n=160 Participants
Race (NIH/OMB) White	40 Participants n=113 Participants	40 Participants n=163 Participants	80 Participants n=160 Participants
Race (NIH/OMB) More than one race	0 Participants n=113 Participants	0 Participants n=163 Participants	0 Participants n=160 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=113 Participants	0 Participants n=163 Participants	0 Participants n=160 Participants
Region of Enrollment Italy	40 participants n=113 Participants	40 participants n=163 Participants	80 participants n=160 Participants
Trial Making Test (TMT) A	25.17 seconds STANDARD_DEVIATION 10.53 • n=113 Participants	24.20 seconds STANDARD_DEVIATION 7.37 • n=163 Participants	24.68 seconds STANDARD_DEVIATION 8.95 • n=160 Participants
Trial Making Test (TMT) B	56.97 seconds STANDARD_DEVIATION 25.37 • n=113 Participants	54.64 seconds STANDARD_DEVIATION 21.30 • n=163 Participants	55.80 seconds STANDARD_DEVIATION 23.33 • n=160 Participants

PRIMARY outcome

Timeframe: 8 weeks - from baseline to end of study

Population: Intention To Treat

Outcome measures

Outcome measures
Measure	Food Supplement n=38 Participants A mix of bacopa, lycopene, astaxanthin and vitamin B12 Dosage form: tablets Dosage: 1 tablet per day Duration: 8 weeks A mix of bioactive natural compounds: A mix of bacopa, lycopene, astaxanthin and vitamin B12 in oral tablets	Placebo n=40 Participants Inactive compound Dosage form: tablets Dosage: 1 tablet per day Duration: 8 weeks Placebo: Inactive compound in oral tablets
Change in Trail Making Test (TMT) B Between Baseline and End of Treatment	-17.63 seconds Standard Deviation 18.93	3.46 seconds Standard Deviation 13.08

PRIMARY outcome

Timeframe: 8 weeks - from baseline to end of study

Population: Intention To Treat

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.

Outcome measures

Outcome measures
Measure	Food Supplement n=38 Participants A mix of bacopa, lycopene, astaxanthin and vitamin B12 Dosage form: tablets Dosage: 1 tablet per day Duration: 8 weeks A mix of bioactive natural compounds: A mix of bacopa, lycopene, astaxanthin and vitamin B12 in oral tablets	Placebo n=40 Participants Inactive compound Dosage form: tablets Dosage: 1 tablet per day Duration: 8 weeks Placebo: Inactive compound in oral tablets
Change Trail Making Test (TMT) A Between Baseline and End of Treatment	-6.86 seconds Standard Deviation 10.00	-0.37 seconds Standard Deviation 5.31

PRIMARY outcome

Timeframe: 8 weeks - from baseline to end of study

Population: Intention To Treat

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.

Outcome measures

Outcome measures
Measure	Food Supplement n=38 Participants A mix of bacopa, lycopene, astaxanthin and vitamin B12 Dosage form: tablets Dosage: 1 tablet per day Duration: 8 weeks A mix of bioactive natural compounds: A mix of bacopa, lycopene, astaxanthin and vitamin B12 in oral tablets	Placebo n=40 Participants Inactive compound Dosage form: tablets Dosage: 1 tablet per day Duration: 8 weeks Placebo: Inactive compound in oral tablets
Change in Trail Making Test (TMT) B - Trail Making Test (TMT) A Between Baseline and End of Treatment	-10.46 seconds Standard Deviation 16.62	3.84 seconds Standard Deviation 11.65

Adverse Events

Food Supplement

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Food Supplement n=40 participants at risk A mix of bacopa, lycopene, astaxanthin and vitamin B12 Dosage form: tablets Dosage: 1 tablet per day Duration: 8 weeks A mix of bioactive natural compounds: A mix of bacopa, lycopene, astaxanthin and vitamin B12 in oral tablets	Placebo n=40 participants at risk Inactive compound Dosage form: tablets Dosage: 1 tablet per day Duration: 8 weeks Placebo: Inactive compound in oral tablets
Infections and infestations Hepatitis E	2.5% 1/40 • Number of events 1 • 8 months	0.00% 0/40 • 8 months

Other adverse events

Other adverse events
Measure	Food Supplement n=40 participants at risk A mix of bacopa, lycopene, astaxanthin and vitamin B12 Dosage form: tablets Dosage: 1 tablet per day Duration: 8 weeks A mix of bioactive natural compounds: A mix of bacopa, lycopene, astaxanthin and vitamin B12 in oral tablets	Placebo n=40 participants at risk Inactive compound Dosage form: tablets Dosage: 1 tablet per day Duration: 8 weeks Placebo: Inactive compound in oral tablets
Respiratory, thoracic and mediastinal disorders Sinusitis	2.5% 1/40 • Number of events 1 • 8 months	0.00% 0/40 • 8 months

Additional Information

Director of Clinical Operations

A.Menarini Industrie Farmaceutiche Riunite Srl

Phone: 0039 055 5680459

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: OTHER