Trial Outcomes & Findings for Nutraceutical Effects on Long-Term Memory (NCT NCT01963767)

Results Overview

Participants will be tested on eyeblink classical conditioning at the USF Health Byrd Alzheimer's Institute. Participants will receive 60 trials of eyeblink conditioning at the two-month follow-up point. Participants watch an entertaining silent video (e.g., Milo and Otis). The airpuff is delivered through a nozzle held in front of the participant and blink latency is recorded. The outcome measure is an index of the percentage of eyeblinks that are made to a tone (conditioned stimulus) after the learning period is complete. The percentage can range from 0% (no conditioned learning has occurred) to 100% (all responses are conditioned; Woodruff-Pak, D. S. (2001). Eyeblink classical conditioning differentiates normal aging from Alzheimer's disease. Integrative Physiological and Behavioral Science, 36(2), 87-108.).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

139 participants

Primary outcome timeframe

Measured at the end of the intervention period, which is two months after initiation of the placebo of NT-020 doses

Results posted on

2014-07-04

Participant Flow

From the 139 participants who were consented in the study, only 113 participated in the baseline assessment. Of the 26 who did not participate in the baseline assessment, 14 failed the screening and 12 dropped out before the baseline assessment.

Participant milestones

Participant milestones
Measure	NT-020 Participants received two pills of NT-020 plus Biovin (900 mg proprietary formulation of blueberry, carnosine, green tea, plus 200 U Vitamin D3, 40 mg Biovin), with one to be taken in the morning and the other in the evening. NT-020: Recommended intake of NT-020 (NutraStem®) is two (2) capsules daily. This comprises Vitamin D3 (2000 IU), BioVin® (40 mg) and the proprietary blend (900mg). This recommended intake was calculated from doses analyzed in scientific research and based on the dose within the submitted patent.	Placebo Subjects took two pills, one in the morning and one in the evening, that were matched in size and shape to the active compound.
Overall Study STARTED	58	55
Overall Study COMPLETED	52	53
Overall Study NOT COMPLETED	6	2

Reasons for withdrawal

Reasons for withdrawal
Measure	NT-020 Participants received two pills of NT-020 plus Biovin (900 mg proprietary formulation of blueberry, carnosine, green tea, plus 200 U Vitamin D3, 40 mg Biovin), with one to be taken in the morning and the other in the evening. NT-020: Recommended intake of NT-020 (NutraStem®) is two (2) capsules daily. This comprises Vitamin D3 (2000 IU), BioVin® (40 mg) and the proprietary blend (900mg). This recommended intake was calculated from doses analyzed in scientific research and based on the dose within the submitted patent.	Placebo Subjects took two pills, one in the morning and one in the evening, that were matched in size and shape to the active compound.
Overall Study Withdrawal by Subject	4	2
Overall Study Adverse Event	2	0

Baseline Characteristics

Nutraceutical Effects on Long-Term Memory

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	NT-020 n=53 Participants Participants received two pills of NT-020 plus Biovin (900 mg proprietary formulation of blueberry, carnosine, green tea, plus 200 U Vitamin D3, 40 mg Biovin), with one to be taken in the morning and the other in the evening. NT-020: Recommended intake of NT-020 (NutraStem®) is two (2) capsules daily. This comprises Vitamin D3 (2000 IU), BioVin® (40 mg) and the proprietary blend (900mg). This recommended intake was calculated from doses analyzed in scientific research and based on the dose within the submitted patent.	Placebo n=52 Participants Subjects took two pills, one in the morning and one in the evening, that were matched in size and shape to the active compound.	Total n=105 Participants Total of all reporting groups
Age, Continuous	74.34 years STANDARD_DEVIATION 5.48 • n=5 Participants	72.82 years STANDARD_DEVIATION 5.54 • n=7 Participants	73.58 years STANDARD_DEVIATION 5.51 • n=5 Participants
Sex: Female, Male Female	32 Participants n=5 Participants	33 Participants n=7 Participants	65 Participants n=5 Participants
Sex: Female, Male Male	21 Participants n=5 Participants	19 Participants n=7 Participants	40 Participants n=5 Participants
Years of Education	15.61 years STANDARD_DEVIATION 2.93 • n=5 Participants	15.88 years STANDARD_DEVIATION 2.41 • n=7 Participants	15.75 years STANDARD_DEVIATION 2.67 • n=5 Participants

PRIMARY outcome

Timeframe: Measured at the end of the intervention period, which is two months after initiation of the placebo of NT-020 doses

Population: From the 105 persons with complete data on the second outcome, only 102 had complete data on this outcome. The three who did not contribute to this analysis were because there were two equipment failures and one person had a glass eye and the procedure could not be performed.

Participants will be tested on eyeblink classical conditioning at the USF Health Byrd Alzheimer's Institute. Participants will receive 60 trials of eyeblink conditioning at the two-month follow-up point. Participants watch an entertaining silent video (e.g., Milo and Otis). The airpuff is delivered through a nozzle held in front of the participant and blink latency is recorded. The outcome measure is an index of the percentage of eyeblinks that are made to a tone (conditioned stimulus) after the learning period is complete. The percentage can range from 0% (no conditioned learning has occurred) to 100% (all responses are conditioned; Woodruff-Pak, D. S. (2001). Eyeblink classical conditioning differentiates normal aging from Alzheimer's disease. Integrative Physiological and Behavioral Science, 36(2), 87-108.).

Outcome measures

Outcome measures
Measure	NT-020 n=50 Participants Participants received two pills of NT-020 plus Biovin (900 mg proprietary formulation of blueberry, carnosine, green tea, plus 200 U Vitamin D3, 40 mg Biovin), with one to be taken in the morning and the other in the evening. NT-020: Recommended intake of NT-020 (NutraStem®) is two (2) capsules daily. This comprises Vitamin D3 (2000 IU), BioVin® (40 mg) and the proprietary blend (900mg). This recommended intake was calculated from doses analyzed in scientific research and based on the dose within the submitted patent. Scientific description of the ingredients of the product per a 2 capsule dose Vitamin D3 (as cholecalciferol) - 2000 IU BioVin® Grape Extract - 40 mg Proprietary Blend - 900mg Green Tea Extract (Camellia sinensis) Wild Blueberries\* (whole fruit) Carnosine VitaBlue® Wild Blueberry Extract\* * Vaccinium angustifolium	Placebo n=52 Participants Subjects took two pills, one in the morning and one in the evening, that were matched in size and shape to the active compound.
Delay Eyeblink Conditioning	52.32 percentage of conditioned responses Standard Deviation 26.85	56.88 percentage of conditioned responses Standard Deviation 28.42

SECONDARY outcome

Timeframe: Measured at baseline and two months

The secondary endpoint will be improvement in cognitive performance over the two-month follow-up period on the paper and pencil tests of cognitive ability. The test that was used here is the Identical Pictures test, from the Educational Testing Services battery (Ekstrom RB, French JW, Harman HH, Dermen D. Manual for kit of factor referenced cognitive tests. Educational Testing Service, Princeton, NJ, 1976.). This test evaluates the number of pictures that persons can match within a 90 second period. There are two trials at 90 seconds and the maximum score is 48 matches (minimum is 0). Higher scores indicate better performance because participants are able to make more matches within the 90 second interval. This test provides an index of processing speed, the ability to do a task rapidly.

Outcome measures

Outcome measures
Measure	NT-020 n=52 Participants Participants received two pills of NT-020 plus Biovin (900 mg proprietary formulation of blueberry, carnosine, green tea, plus 200 U Vitamin D3, 40 mg Biovin), with one to be taken in the morning and the other in the evening. NT-020: Recommended intake of NT-020 (NutraStem®) is two (2) capsules daily. This comprises Vitamin D3 (2000 IU), BioVin® (40 mg) and the proprietary blend (900mg). This recommended intake was calculated from doses analyzed in scientific research and based on the dose within the submitted patent. Scientific description of the ingredients of the product per a 2 capsule dose Vitamin D3 (as cholecalciferol) - 2000 IU BioVin® Grape Extract - 40 mg Proprietary Blend - 900mg Green Tea Extract (Camellia sinensis) Wild Blueberries\* (whole fruit) Carnosine VitaBlue® Wild Blueberry Extract\* * Vaccinium angustifolium	Placebo n=53 Participants Subjects took two pills, one in the morning and one in the evening, that were matched in size and shape to the active compound.
Cognitive Performance	24.12 units on a scale Standard Error .65	21.72 units on a scale Standard Error .61

Adverse Events

NT-020

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	NT-020 n=52 participants at risk Participants received two pills of NT-020 plus Biovin (900 mg proprietary formulation of blueberry, carnosine, green tea, plus 200 U Vitamin D3, 40 mg Biovin), with one to be taken in the morning and the other in the evening. NT-020: Recommended intake of NT-020 (NutraStem®) is two (2) capsules daily. This comprises Vitamin D3 (2000 IU), BioVin® (40 mg) and the proprietary blend (900mg). This recommended intake was calculated from doses analyzed in scientific research and based on the dose within the submitted patent. Scientific description of the ingredients of the product per a 2 capsule dose Vitamin D3 (as cholecalciferol) - 2000 IU BioVin® Grape Extract - 40 mg Proprietary Blend - 900mg Green Tea Extract (Camellia sinensis) Wild Blueberries\* (whole fruit) Carnosine VitaBlue® Wild Blueberry Extract\* * Vaccinium angustifolium	Placebo n=53 participants at risk Subjects took two pills, one in the morning and one in the evening, that were matched in size and shape to the active compound.
Cardiac disorders Cardiac disorders	1.9% 1/52 • Number of events 1	0.00% 0/53

Other adverse events

Other adverse events
Measure	NT-020 n=52 participants at risk Participants received two pills of NT-020 plus Biovin (900 mg proprietary formulation of blueberry, carnosine, green tea, plus 200 U Vitamin D3, 40 mg Biovin), with one to be taken in the morning and the other in the evening. NT-020: Recommended intake of NT-020 (NutraStem®) is two (2) capsules daily. This comprises Vitamin D3 (2000 IU), BioVin® (40 mg) and the proprietary blend (900mg). This recommended intake was calculated from doses analyzed in scientific research and based on the dose within the submitted patent. Scientific description of the ingredients of the product per a 2 capsule dose Vitamin D3 (as cholecalciferol) - 2000 IU BioVin® Grape Extract - 40 mg Proprietary Blend - 900mg Green Tea Extract (Camellia sinensis) Wild Blueberries\* (whole fruit) Carnosine VitaBlue® Wild Blueberry Extract\* * Vaccinium angustifolium	Placebo n=53 participants at risk Subjects took two pills, one in the morning and one in the evening, that were matched in size and shape to the active compound.
Gastrointestinal disorders Upset Stomach	3.8% 2/52 • Number of events 2	1.9% 1/53 • Number of events 1

Additional Information

Dr. Brent Small

University of South Florida

Phone: 813-974-9746

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place