Executive functioning in healthy individuals Not Applicable
Conditions
Interventions
Subjects consume capsules containing 400 mg of placebo (PL)
or 200 mg of PL + 200 mg of caffeine (CA)
or 200 mg of PL+ 200 mg of PX (ENFINITY™, Ingenious Ingredients, Lewisville, TX, USA)
or 200 mg CA + 200 mg of PX (CA+PX) with a 7 – 14 day washout between treatments. Capsules are taken with 8 ounces of water. A computer-generated randomization to treatment is used. Once subjects are
Sponsors
Ingenious Ingredients L.P.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: All subjects were healthy and free from known: (1) a medical condition which hinders performance in a standard exercise program; (2) a history of cognitive dysfunction; (3) been currently taking prescription medications; (4) a known allergy to wheat flour; (5) a sleep disorder; (6) been/were pregnant or breastfeeding; or (7) a physician’s order to abstain/restrict caffeine or stimulant intake
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 physical exercise, 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 hour after initial ingestion and after the completion of a 10-kilometer run. 2. Psychomotor Vigilance Task Test (PVTT) at baseline, 1 hour after initial ingestion and after the completion of a 10-kilometer run. | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety measured using: 1. Side Effect Questionnaire at baseline, 1 hour after initial ingestion and after the completion of a 10-kilometer run. 2. Changes in blood clinical chemistries at baseline, 1 hour after initial ingestion and after the completion of a 10-kilometer run. 3. Changes in heart rate after initial ingestion and after each kilometer runing. | — |
Countries
United States of America
Outcome results
None listed