Executive functioning in healthy individuals Not Applicable
Conditions
Interventions
Subjects consume capsules containing 50, 100 or 200 mg of paraxanthine (ENFINITY™, Ingenious Ingredients L.P., Lewisville, TX, USA) or capsules containing wheat flour placebo (placebo) once they have
Sponsors
Ingenious Ingredients L.P.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: All subjects were healthy and free from known: 1. Cognitive deficit conditions 2. Wheat flour allergies 3. Sleep disorders 4. Cardiovascular, metabolic, or pulmonary diseases 5. History of hypertension, migraine headaches, cardiac arrhythmias, or anxiety 6. Gastrointestinal reflux disease or ulcers
Exclusion criteria
Exclusion criteria: Subjects who were taking prescription medications in the month prior to the initiation of the study and/or were told by a physician to abstain or restrict caffeine and/or stimulant intake
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The Psychology Experiment Building Language (PEBL) software program (Version 2.1, http://pebl.sourceforge.net) was used to administer four cognitive function tests that assessed a range of cognitive and executive function aspects: 1. Berg-Wisconsin Card Sorting Task test (BCST) at baseline, 1, 2, 3, 4, 5 and 6 hours after initial ingestion and 1 hour after daily ingestion for 7 days 2. The Go/No-Go test (GNG) at baseline, 1, 2, 3, 4, 5 and 6 hours after initial ingestion and 1 hour after daily ingestion for 7 days 3. Sternberg Task Test (STT) at baseline, 1, 2, 3, 4, 5 and 6 hours after initial ingestion and 1 hour after daily ingestion for 7 days 4. Psychomotor Vigilance Task Test (PVTT) at baseline, 1, 2, 3, 4, 5 and 6 hours after initial ingestion and 1 hour after daily ingestion for 7 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety measured using: 1. Side Effect Questionnaire: participants will rank the frequency of dizziness, headache, tachycardia, heart skipping/palpitations, shortness of breath, nervousness, blurred vision, and any other adverse effects) using a scale where 0 = none; 1 = 1-2/week, 2 = 3-4/week, 3 = 5-6/week, 4 = 7-8/week, and 5 = =9/week. They will also rate the severity of these side effects where 0 = none, 1 = minimal, 2 = slight, 3 = moderate, 4 = severe, and 5 = very severe at baseline, 6 hours after the first ingestion, and 1 hour after daily ingestion on day 7 2. Changes in blood clinical chemistries at baseline, 6 hours after the first ingestion, and 1 hour after daily ingestion on day 7 | — |
Countries
United States of America
Outcome results
None listed