Long-Term PEA Safety Study

Launched by RDC CLINICAL PTY LTD · Dec 3, 2024

Keywords

ClinConnect Summary

The Long-Term PEA Safety Study is a clinical trial designed to find out if taking PEA (a natural supplement) is safe for healthy adults when used over a long period of time. The study is open to both men and women who are 18 years or older and generally healthy. To participate, individuals must meet certain criteria, such as having a body mass index (BMI) between 18.5 and 35.0 and not having serious health issues like cancer or heart disease.

Participants in the trial will be randomly assigned to receive either the PEA supplement or a placebo (which is a harmless substitute that looks the same but contains no active ingredients) for 12 months. They will visit the clinic several times for safety checks and will also have phone check-ins during the study. Participants will not know which product they are taking. This trial is currently recruiting, and those interested should be aware that they cannot take part in another clinical trial at the same time.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Adults (18 years and older)
• • Generally healthy
• • Able to provide informed consent
• • BMI 18.5 - 35.0 kg/m2
• • Agree to not participate in another clinical trial during enrolment period
• Exclusion Criteria:
• • Current malignancy (excluding Basal Cell Carcinoma) or chemotherapy or radiotherapy treatment for malignancy within the previous 2 years
• • Serious illness e.g., mood disorders (such as depression or bipolar disorder), anxiety, neurological disorders (such as MS), kidney disease, liver disease or heart conditions
• • Unstable illness (e.g., diabetes and thyroid gland dysfunction)
• • History of renal function impairment
• • Currently taking Coumadin (Warfarin), Heparin, Dalteparin, Enoxaparin or other anticoagulation therapy \[(excluding low dose aspirin (under 300 mg/day)\]
• • Regular consumption (\>4 times a week) of PEA over the past 2 weeks
• • Substance Abuse (illicit and/or prescription) Drug (prescription or illegal substances) abuse
• • Chronic past (within 12-months) and/or current alcohol use (\>14 alcoholic drinks week)
• • Pregnant or lactating women
• • Allergic, sensitive, or intolerant to any of the ingredients in active or placebo formula
• • Has a clinically significant abnormal finding on the medical assessment, medical history, vital signs or clinical laboratory results at screening.
• • Participants who are currently participating in any other clinical trial or who have participated in any other clinical trial during the past 1 month.
• • Any condition which in the opinion of the investigator makes the participant unsuitable for inclusion.