Nutraceutical Effects on Long-Term Memory
Condition: Aging
Intervention: NT-020; Placebo
Intervention description: 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.
Phase: Phase 2
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 139.0
Sex: All
Minimum age: 65 Years
Maximum age: 85 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: memory; cognition; dietary supplements

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.
    

Eligibility 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.