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

Rationale

Although few in vivo and in vitro studies have demonstrated the immunomodulatory effect of Gamma-oryzanol, but no human study is available regarding its effect on immunity and cognition. Therefore, the present study is designed to explore the effect of Gamma-oryzanol on immunity in healthy volunteers.

|Objectives

1.       To compare the mean changes in the immunomodulatory parameters between the gamma-oryzanol and placebo groups from baseline to 60 days. These will include, Evaluation of the changes in baseline value of Th1 and Th2 cytokines (interferon-gamma and interleukin-4), IgA, IgG, IgM and IgE, baseline counts of T-cell (CD4+, CD8+), B-cell (CD19), TNF-alpha and NK-cells (CD16+, CD56+), IL-2, IL-4, IL-6, IL-8 and IL-10, serum cortisol and CRP levels between the groups and mental assessment tests between groups of healthy subjects.

2.       To assess the safety of the Gamma-oryzanol as compared to the placebo group by estimation of Basic vital signs, Liver function tests, Kidney function tests, Thyroid function tests, and Lipid profile

|Number of Subjects

30

|Diagnosis and Main Inclusion and Exclusion criteria

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

i.              Evidence of renal disease (S. Creatinine > 1.5mg/ml)

ii.             Evidence of liver disease (AST/ALT >3 times of normal)

iii.            Pregnant and lactating mothers and women intending pregnancy

iv.           History of alcohol intake and smoking.

v.            Participation in any other clinical trial within the last 30 days

vi.           History of intake of dietary supplements or any immunomodulatory drugs.

vii.          Participants taking Rice bran oil in diet regularly.

viii.         History of intolerance or hypersensitivity to gamma-oryzanol.

ix.           Clinically diagnosed with Alzheimer’s disease or dementia

x.            Prior history of stroke, dementia, Parkinson’s disease, fibromyalgia, multiple sclerosis, seizures/epilepsy or other known diseases that affect memory or cognition

xi.           Taking any medicines that are stimulants including amphetamine, methylphenidate, atomoxetine hydrochloride, or lisdexamfetamine dimesylate.

xii.          GI disorders known to impair absorption of nutrients.

xiii.         Traumatic brain injury (TBI) in personal history.

xiv.         Any condition which in the opinion of the PI that is significant and can make the subject unsuitable for the study or can place it under additional risks, such as intolerance, allergy to gamma-oryzanol

|Study product, Dose, Route,

Regiment

Arms

Assigned Interventions

|Active comparator

Gamma-Oryzanol (300 mg) once daily orally

|Control

Matched Placebo once orally

|Duration of administration

 60

|Study endpoints

·         To evaluate changes in the levels of immunomodulatory parameters at 0th day and 60th day of the study in both groups.

·         To assess the safety of Gamma-Oryzanol

|Statistics

Data will be analyzed using appropriate parametric and non-parametric tests depending upon the nature of data

|Publication of Research Data

After completion of the study, the outcome of the study results will be published in a scientific journal.