A randomized double blind clinical study to evaluate the effect of Gamma-oryzanol on immunity and cognition in healthy volunteers

AP Organics Limited0 个研究点目标入组 0 人开始时间: 待定最近更新: 2022年10月17日

试验速览

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•i.Age above 18 years
•ii.Healthy participants (health status confirmed by clinical history, Physical Exam and routine blood analysis) from both gender
•iii.Participant must not have taken any vitamin / mineral/ dietary or herbal supplements, 1 month prior to enrolling in the study and agrees to not use any new vitamins and/or minerals and/or dietary and/or herbal supplements until after study completion.
•iv.Participant must be able, willing and likely to fully comply with study procedures and restrictions.
•v.Participant must be literate or have a basic primary education.
•vi.Participant willing to sign the informed consent

•Evidence of renal disease (S. Creatinine > 1.5mg/ml)
•Evidence of liver disease (AST/ALT >3 times of normal)
•Pregnant and lactating mothers intending pregnancy
•History of alcohol intake and smoking
•Participation in any other clinical trial within the last 30 days.
•History of intake of dietary supplements or immunomodulatory drugs.
•Participants taking rice bran oil in their diet regularly.
•History of intolerance or hypersensitivity to gamma oryzanol.
•Clinically diagnosed with alzheimers disease.
•Prior history of stroke, dementia, Parkinsons disease, fibromyalgia, multiple sclerosis, epilepsy or other known diseases that affect memory or cognition
•Taking any medicines that are stimulants including amphetamine, methylphenidate, atomoxetine hydrochloride, or lisdexamfetamine dimesylate.
•GI disorders known to impair absorption of nutrients.
•Traumatic brain injury in personal history.
•Any condition which in the opinion of the PI that is significant and can make the subject unsuitable for study or can place it under additional risk, such as intolerance, allergy to gamma-oryzanol.

发起方

AP Organics Limited