Effect of gamma oryzanol on immunity in healthy volunteers

Completed

Conditions: Healthy condition

Registration Number: CTRI/2021/03/031920

Lead Sponsor: AP Organics Limited

Brief Summary: | | |

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|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. 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

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 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 with in 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.        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 product, Dose, Route, Regiment

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|Arms

Assigned Interventions

|Active comparator

Gamma-Oryzanol (300 mg) once daily orally (Capsule)

|Control

Matched Placebo once orally

|Duration of administration

60 days

|Study end points

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

Â·         To assess Safety of the Gamma-oryzanol

|Statistics

Data will be analyzed using appropriate parametric and non-parametric test 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

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 30

Inclusion Criteria

i.Healthy participants (health status confirmed by clinical history, Physical Exam and routine blood analysis) from both gender ii.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.
iii.Participant must be able, willing and likely to fully comply with study procedures and restrictions.
iv.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 with in 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.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
Mean â€¢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, Mean percent changes in baseline values of serum cortisol (at 0 day, 30th day and 60th day) and CRP levels between the groups.	Mean â€¢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, Mean percent changes in baseline values of serum cortisol (at 0 day, 30th day and 60th day) and CRP levels between the groups.

Secondary Outcome Measures

Name	Time	Method
i.To assess the adverse drug reactions in both group	ii.Mean percent changes between gamma-oryzanol and placebo trial arms from baseline to 60 days as in:

Trial Locations

Locations (1): GMERS Medical College and Civil Hospital
🇮🇳
Ahmadabad, GUJARAT, India
GMERS Medical College and Civil Hospital
🇮🇳Ahmadabad, GUJARAT, India
Dr Shital Panchal
Principal investigator
09687626589
shital.panchal@nirmauni.ac.in