Clinical trial on paraxanthine (PX) in comparison to that of caffeine (CF) in otherwise healthy volunteers
- Registration Number
- CTRI/2022/03/041219
- Lead Sponsor
- Ingenious Ingredients
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 24
1.Subject has provided written and dated informed consent to participate in the study.
2.Subject is willing and able to comply with the protocol.
3.Subject is a male/female between 18 and 55 years of age.
1.Subject is a slow caffeine metabolizer [determined by genome testing regarding the enzyme in the liver that metabolizes caffeine, p450 1A2 (CYP1A2)].
2.Subject is participating in another clinical trial or has received an investigational product within thirty days prior to enrollment.
3.Subject has a history of alcohol or other drug abuse in the past year.
4.Subject has a significant history or current presence of treated or untreated bleeding disorder, diabetes mellitus, high blood pressure (BP) [systolic BP > 140 and/or diastolic BP > 90], thyroid disease, tachyarrhythmia, heart disease, kidney disease, or liver disease.
5.Subject currently suffers from a sleep disorder and/or has a known history of (or is currently being treated for) clinical anxiety, eating disorder(s) or any other psychiatric condition(s), which in the opinion of the investigator, might put the subject at risk and/or confound the results of the study.
6.Subject has a known allergy or sensitivity to any ingredient in the test product.
7.Subject has any medical condition or uses any medication, nutritional product, dietary supplement or program, which in the opinion of the investigator, might interfere with the conduct of the study or place the subject at risk.
8.Investigator is uncertain about subjectââ?¬•s capability or willingness to comply with the protocol requirements.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.The % change in the taste as perceived by the feedback from average number of subjects (from Day 0 to Day 7) between same strengths of PX and CF and also with respective placebo groups. <br/ ><br>2.The % change in the memory/cognition enhancement as perceived by the questionnaires and biomarkers between same strengths of PX and CF and also with respective placebo groups (from Day 0 to Day 7). <br/ ><br>3.The % change in the anxiety as perceived by the questionnaires and biomarkers between same strengths of PX and CF and also with respective placebo groups (from Day 0 to Day 7). <br/ ><br>4.The % change in the vital parameters between same strengths of PX and CF and also with respective placebo groups (from Day 0 to Day 7). <br/ ><br>Timepoint: Day 0 to Day 7
- Secondary Outcome Measures
Name Time Method Adverse eventsTimepoint: Day 0 to Day 21