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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
Sponsor:
Information provided by (Responsible Party):
University of South Florida

Brief Summary:
Interventions to improve the cognitive health of older adults are of critical importance. In the current protocol, ithe investigators conducted a short-term (two months) randomized clinical trial to examine the influence of the nutraceutical NT-020 on the cognitive performance of older adults. Participants were tested with a battery of cognitive tasks at baseline and two months after being randomized to the interventional drug or placebo.

Condition or disease Intervention/treatment Phase
Aging Drug: NT-020 Dietary Supplement: Placebo Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 139 participants
Allocation: Randomized
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

Arm Intervention/treatment
Experimental: 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.
Drug: 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

Other Ingredients:

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.




Primary Outcome Measures :
  1. 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.).



Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   65 Years to 85 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Adults 65-85 years of age (inclusive).
  • Able to understand and sign the informed consent.
  • Native English-speaking.
  • No evidence of dementia (MMSE >=23).
  • Each subject must be willing to give consent after being informed of the experimental nature of therapy, alternatives, potential benefits, side-effects, risks and discomforts.
  • All subjects must be willing to be monitored for adequacy of nutritional intake during the intervention, as is the current standard of clinical practice.

Exclusion Criteria:

  • Use of high dose antioxidant supplements other than what is provided in the trial.
  • History of known allergy to components of the study supplements.
  • Mental illness judged by the PI to preclude a successful completion of the trial.
  • Persons who are not native English speakers are excluded from the current proposal because many of the cognitive tests that are administered are language-based and are heavily influenced by first language.
  • Other acute or chronic medical or psychiatric condition or laboratory abnormality that may increase risk associated with study participation or study drug administration, or may interfere with interpretation of study results, and in the judgment of the investigator would make the subject inappropriate for entry into this study.

Information from the National Library of Medicine

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


Locations
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United States, Florida
University of South Florida
Tampa, Florida, United States, 33620
Sponsors and Collaborators
University of South Florida
Investigators
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Principal Investigator: Brent J Small, PhD University of South Florida

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Responsible Party: University of South Florida
ClinicalTrials.gov Identifier: NCT01963767     History of Changes
Other Study ID Numbers: Pro00001021
24127 ( Other Grant/Funding Number: University of South Florida )
First Posted: October 16, 2013    Key Record Dates
Results First Posted: July 4, 2014
Last Update Posted: July 4, 2014
Last Verified: April 2014

Keywords provided by University of South Florida:
memory
cognition
dietary supplements