Nutraceutical Effects on Long-Term Memory

NCT01963767 | Completed Phase 2 Results

• 2 other identifiers: Pro0000102124127
• Study Type: interventional
• Target: 139
• Locations: 1 country
• Sites: 1

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.

Conditions

Aging

Keywords

memory; cognition; dietary supplements

Outcome Measures

Primary Outcomes (1)

• Delay Eyeblink Conditioning

  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.).

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

Secondary Outcomes (1)

• Cognitive Performance

  Measured at baseline and two months

Study Arms (2)

NT-020

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Interventions

NT-020 DRUG

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.

Also known as: Naturatherapeutics Nutrastem

NT-020

Placebo DIETARY_SUPPLEMENT

Also known as: Participants were to take two placebo pills, one in the morning and one at dinner.

Placebo

Eligibility Criteria

• Age: 65 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of South Florida: lead

Study Sites (1)

University of South Florida

Tampa, Florida, 33620, United States

Location

MeSH Terms

Interventions

NT020 formula

Results Point of Contact

• Title: Dr. Brent Small
• Organization: University of South Florida

bsmall@usf.edu

813-974-9746

Study Officials

• Brent J Small, PhD

  University of South Florida

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2013
• First Posted: October 16, 2013
• Study Start: May 1, 2011
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: July 4, 2014
• Results First Posted: July 4, 2014

Record last verified: 2014-04

Locations

US (1)