Does paraxanthine provide greater improvement in cognitive function than caffeine or in combination with caffeine prior to and following running?

Not Applicable

Completed

Conditions: Executive functioning in healthy individuals
Not Applicable

Registration Number: ISRCTN14506218

Lead Sponsor: Ingenious Ingredients L.P.

Brief Summary: 2024 Results article in https://pubmed.ncbi.nlm.nih.gov/38725238/ (added 17/05/2024)

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 13

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

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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:<br>1. Berg-Wisconsin Card Sorting Task test (BCST) at baseline, 1 hour after initial ingestion and after the completion of a 10-kilometer run.<br>2. Psychomotor Vigilance Task Test (PVTT) at baseline, 1 hour after initial ingestion and after the completion of a 10-kilometer run.

Secondary Outcome Measures

Name	Time	Method
Safety measured using:<br>1. Side Effect Questionnaire at baseline, 1 hour after initial ingestion and after the completion of a 10-kilometer run.<br>2. Changes in blood clinical chemistries at baseline, 1 hour after initial ingestion and after the completion of a 10-kilometer run.<br>3. Changes in heart rate after initial ingestion and after each kilometer runing.