The Effects of a Combination of Nootropic Ingredients on Cognition in Healthy Young Volunteers

NCT02857829 | Completed

• 1 other identifier: Nootrobox_Maastricht
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

Achieving optimal concentration during cognitively demanding tasks is of immense human value. Despite our understanding of the important role that attention, working memory, and fluid intelligence play in professional success, and the huge individual differences in these constructs, the modulation of these cognitive domains has not been rigorously studied. From the widespread use of caffeine, to the more questionable and increasing use of prescription medications to achieve peak attention, the tremendous interest in achieving cognitive performance has driven individuals to experiment, often with prescription and illegal drugs. Herein, we aim to standardize and extend the study of attention modulating substances, to identify blends that achieve safe enhancements in attention and working memory. Specific to this proposal, we aim to develop CAF+, a blend of natural and generally regarded as safe compounds to improve attention and working memory in normal, healthy individuals. CAF+ is composed of caffeine (100 mg), L-theanine (200 mg), vinpocetine (40 mg), L-tyrosine (300 mg), pyridoxine (0.06 mg), and cobalamin (20 mg).

Conditions

Biomedical Enhancement

Keywords

Cognition; working memory; nootropic; reaction time; healthy individuals; cognitive enhancement

Outcome Measures

Primary Outcomes (1)

• Verbal Memory: Immediate recall score

  Verbal Memory will be assessed by an adjusted version of the Rey Auditory Verbal Learning Test (Lezak, 1995): the visual verbal learning test (Riedel, Klaassen, Deutz, van Someren, \& van Praag, 1999). This test consists of a list of 30 Dutch monosyllabic words (18 nouns, 12 adjectives) of which subjects have to remember as many as possible. All words are presented one by one on a computer screen, in three trials with the same item sequence. After each trial, the subjects are asked to name as many words as they can (immediate recall). Thirty minutes after the third trial, the subject is requested to recall as many words as possible (delayed recall). Next to the delayed recall, a recognition test will be assessed, consisting of all former and 30 comparable new words. Subjects are asked to respond whether they have seen the word during the learning trials by means of pressing a "yes" or a "no" button.

  Up to 12 weeks

Secondary Outcomes (5)

• Verbal Memory: Delayed recall score

  Up to 12 weeks

• Working memory

  Up to 12 weeks

• Response inhibition and focused attention

  Up to 12 weeks

• Complex-scanning and visual tracking

  Up to 12 weeks

• Simple and -choice reaction time

  Up to 12 weeks

Other Outcomes (2)

• Heart Rate

  Up to 12 weeks

• Blood Pressure

  Up to 12 weeks

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Other: Placebo

Caffeine-alone

ACTIVE COMPARATOR

The effects of the combination will be compared to both placebo and caffeine-alone, to test the hypothesis that the blend of ingredients will enhance cognitive measures greater than the most commonly used cognitive enhancer, caffeine.

Dietary Supplement: Caffeine-alone

CAF+

EXPERIMENTAL

Dietary Supplement: CAF+

Interventions

CAF+ DIETARY_SUPPLEMENT

CAF+ will be a blend consisting of caffeine (100 mg), L-theanine (200 mg), vinpocetine (40 mg), L-tyrosine (300 mg), pyridoxine (1 mg), and cobalamin (20 mg).

CAF+

Caffeine-alone DIETARY_SUPPLEMENT

Caffeine (100 mg)

Caffeine-alone

Placebo OTHER

Rice flour

Placebo

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• BMI between 18.5-30
• Willing to sign informed consent

You may not qualify if:

• Suffer from or have a history of cardiac, hepatic, renal, pulmonary, neurological, gastrointestinal, haematological or psychiatric illness (Also those volunteers who have a first-degree relative with a psychiatric disorder or a history with a psychiatric disorder will be excluded)
• Alcohol consumption \>20 drinks/week
• pregnant or lactating
• use of medication of than oral contraceptives
• use of recreation drugs 2 weeks before until the end of the experiment
• any motor or sensory deficits which could reasonably be expected to affect test performance

Sponsors & Collaborators

• Nootrobox, Inc.: lead

Study Sites (1)

Maastricht University

Maastricht, Netherlands

Location

Study Officials

• Arjan Blokland, PhD

  Maastricht University

  PRINCIPAL INVESTIGATOR

• Anke Sambeth, PhD

  Maastricht University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2016
• First Posted: August 5, 2016
• Study Start: March 1, 2017
• Primary Completion: March 24, 2017
• Study Completion: March 24, 2017
• Last Updated: December 22, 2017

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)