Dose-response of paraxanthine on brain functio
Not Applicable
Completed
- Conditions
- Executive functioning in healthy individualsNot Applicable
- Registration Number
- ISRCTN68592648
- Lead Sponsor
- Ingenious Ingredients L.P.
- Brief Summary
2021 Results article in https://doi.org/10.3390/nu13124478 (added 05/01/2022)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 15
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> 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, 2, 3, 4, 5 and 6 hours after initial ingestion and 1 hour after daily ingestion for 7 days<br> 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<br> 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<br> 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<br>
- Secondary Outcome Measures
Name Time Method <br> Safety measured using:<br> 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<br> 2. Changes in blood clinical chemistries at baseline, 6 hours after the first ingestion, and 1 hour after daily ingestion on day 7<br>