Nutraceutical Effects on Long-Term Memory
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|ClinicalTrials.gov Identifier: NCT01963767|
Recruitment Status : Completed
First Posted : October 16, 2013
Results First Posted : July 4, 2014
Last Update Posted : July 4, 2014
|Condition or disease||Intervention/treatment||Phase|
|Aging||Drug: NT-020 Dietary Supplement: Placebo||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||139 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Primary Purpose:||Basic Science|
|Official Title:||Phase II Study of a Nutraceutical on the Cognitive Performance of Older Adults.|
|Study Start Date :||May 2011|
|Actual Primary Completion Date :||February 2013|
|Actual Study Completion Date :||February 2013|
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.
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*
Magnesium stearate, Cellulose (vegetarian capsules) Contains no yeast, wheat, corn, milk, egg, soy, glutens, artificial colors or flavors, added sugar, starch or preservatives.
Other Name: Naturatherapeutics Nutrastem
Placebo Comparator: 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.
Dietary Supplement: Placebo
Other Name: Participants were to take two placebo pills, one in the morning and one at dinner.
- Delay Eyeblink Conditioning [ Time Frame: Measured at the end of the intervention period, which is two months after initiation of the placebo of NT-020 doses ]
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.).
- Cognitive Performance [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01963767
|United States, Florida|
|University of South Florida|
|Tampa, Florida, United States, 33620|
|Principal Investigator:||Brent J Small, PhD||University of South Florida|