Effect of gamma oryzanol on immunity and cognition in healthy volunteers

Recruitment & Eligibility

Status: Suspended

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

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

Exclusion Criteria

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes in baseline value of Th1 and Th2 cytokines (IFN-gamma, IgA, IgG, IgM and IgE between the groups. <br/ ><br>Changes in baseline counts of T-cell, B-cell, TNF-alpha, NK-cells, IL-2, IL-4, IL-6 between the groups <br/ ><br>Mean percent changes in baseline values of serum cortisol and CRP levels between the groups. <br/ ><br>Eriksen flanker task <br/ ><br>The Mackworth clock test <br/ ><br>Wisconsing Card Sorting Test <br/ ><br>Mental rotation task <br/ ><br>ACE-III <br/ ><br>Trail Making Test (TMT)Timepoint: Outcome will be assessed after 60days treatment.

Secondary Outcome Measures

Name	Time	Method
To assess the adverse drug reactions in both group <br/ ><br>Improvement from baseline in the Index scores of immediate memories, general memory, working memory, attention and fluency in language after therapy, and visual-spatial skills and task switching after therapy. <br/ ><br>Mean percent changes between gamma-oryzanol and placebo trial arms from baseline to 60 days as in: <br/ ><br>a.Basic vital signs <br/ ><br>b.Liver function tests <br/ ><br>c.Kidney function tests <br/ ><br>d.Thyroid function tests <br/ ><br>e.Lipid profile <br/ ><br>Timepoint: ADR monitoring will be throughout the study duration, rest of the parameters will be assessed on 0 and 60th day of the treatment