Acute Effects of Paraxanthine on Energy and Focus

Completed · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Cognition, Appetite, Mental Energy, Dietary Supplement

In brief

This study aims to evaluate the effects of paraxanthine (200 mg and 300 mg) on energy, focus, appetite, and cognitive performance in healthy adults. Using a double-blind, placebo-controlled, crossover design, participants will receive paraxanthine or placebo 30 minutes before a meal. Cognition tests and visual Analogue Scale (VAS) ratings for energy, focus, productivity, satiety, and appetite will be collected at multiple time points post-consumption.

Key facts

Study ID

NCT06628596

Run by

Iovate Health Sciences International Inc

People needed

25

Starts

2024-05-07

Expected to finish

2024-08-14

Last updated by the study team

2024-10-08

Who can join

Age: 20 and older, up to 40. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Voluntarily provide signed and dated informed consent.
• Be in good health as determined by medical history and routine blood chemistries.
• Age between 20 and 40 years (inclusive).
• Body Mass Index of 18.5-29.9 (inclusive).
• Body weight of at least 120 pounds.
• Normotensive (supine, resting systolic blood pressure <140 mm Hg and diastolic blood pressure < 90 mm Hg. If the first measurement is slightly elevated above these limits, the subject will be given a brief (5 minute) rest period, and two more measurements will be taken. The average of all three measurements will be used to determine eligibility.
• Normal supine, resting heart rate (< 90 per minute).
• Willing to duplicate their previous 24-hour diet, refrain from alcohol, caffeine, and exercise for 24 hr prior to each trial, and fast for 8 hours prior to each trial.

You may not qualify if…

• Current smoker or other nicotine use (i.e. vape, patch, etc.).
• History of malignancy in the previous 5 years except for non-melanoma skin cancer (basal cell cancer or squamous cell cancer of the skin).
• Prior gastrointestinal bypass surgery (Lapband, etc.).
• Other known gastrointestinal or metabolic diseases that might impact nutrient absorption or metabolism, e.g. electrolyte abnormalities, diabetes, thyroid disease, adrenal disease, hypogonadism, short bowel syndrome, diarrheal illnesses, history of colon resection, gastric ulcer, reflux disease, gastroparesis, Inborn-Errors-of-Metabolism (such as PKU).
• Chronic inflammatory condition or disease (e.g. rheumatoid arthritis, Crohn's disease, ulcerative colitis, Lupus, HIV/AIDS, etc.).
• History of hepatorenal, musculoskeletal, autoimmune, or neurologic disease.
• History of cognitive disorder.
• History of psychiatric disorder.
• Known sensitivity to any ingredient in the test formulations as listed in the Certificates-of-Analysis.
• Women currently pregnant, trying to become pregnant or breastfeeding a child.
• Use of anxiety or ADHD medication.
• Caffeine intake of three or more cups of coffee or equivalent (>400 mg) per day.
• Alcohol consumption (more than 2 standard alcoholic drinks per day or more than 10 drinks per week) or drug abuse or dependence.
• Clinically significant abnormal laboratory results at screening.
• Prior gastrointestinal bypass surgery (Lapband, etc.).
• Currently participating in another research study with an investigational product or have been in another research study in the past 30 days.
• Any other diseases or conditions that, in the opinion of the medical staff, could confound the primary endpoint or place the subject at increased risk of harm if they were to participate.

Where it is running

• The Center For Applied Health Sciences — Canfield, Ohio, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.