Clinical Trial to Investigate the Efficacy and Safety of LN-OS-22 on Oxidative Stress and Systemic Inflammation in Overweight and Obese Population.

Inclusion criteria

• Males and females aged ≥30 -≤60 years.
• No history of systemic infection as assessed by normal total leucocyte count.
• Overweight and obese participants (at high risk of oxidative stress and inflammation) identified as BMI ≥ 25.0 kg/m2 and ≤ 34.9 kg/m2
• Individuals having a risk of metabolic syndrome as indicated by three or more of the following five criteria:

a Waist circumference more than 102 cm for males or 88 cm for females b Blood pressure of more than 130/85 mmHg c Fasting triglyceride (TG) level ≥ 150 mg/dl d Fasting high-density lipoprotein cholesterol level ≤ 40 mg/dl for males or 50 mg/dl for females e Fasting blood glucose ≥ 100 mg/dl.

• Individuals physically inactive for 1/3rd of the wake time as per the Longitudinal Aging Study Amsterdam (LASA) sedentary behavior questionnaire
• Non-smokers (Past smokers can be allowed if they have abstinence for a minimum of 2 years)
• Able to comply and perform the procedures requested by the protocol (including dietary restrictions, consumption of study interventions, blood and urine sample collection procedures, and study visit schedule)
• Participants who are literate enough to read and understand the consent form and provide voluntary consent.
• Participants who can give written informed consent and willing to participate in the study and comply with its procedures.

Exclusion criteria

• Known sensitivity to the investigational product or any excipients of the drug product.
• Known case of lactose intolerance.
• Known case of type I diabetes.
• Presence of uncontrolled type II diabetes mellitus (indicated by HbA1c ≥ 6.5).
• Presence of uncontrolled hypertension (defined as Systolic Blood Pressure (SBP) ≥ 140 mm Hg and/or Diastolic Blood Pressure (DBP) ≥ 90 mm Hg).
• Presence thyroid dysfunction (defined as thyroid stimulating hormone (TSH) level < 0.4 to > 4.2 mIU/L).
• Participants with moderate to severe anemia defined as hemoglobin <10 gm/dL- in the case of females and < 11 gm/dL- in the case of males will be excluded from the study.
• Consumption of any herbal preparation, supplements, nutritional therapy, etc. which is expected to reduce oxidative stress within 1 month prior to screening and throughout the study period.
• History of any significant neurological and psychiatric condition which may affect the participation and inference of the study's endpoints.
• History of use of anti-inflammatory therapies for any ailments within 7 days prior to randomization.
• Participation in other clinical trials in the last 3 months prior to screening
• Participants with substance abuse problems (within 2 years) defined as:

a Use of recreational drugs (such as cocaine, methamphetamine, marijuana, etc.)/Nicotine dependence.

b High-risk drinking as defined by the consumption of 4 or more alcohol-containing beverages on any day or 8 or more alcohol-containing beverages per week for women and 5 or more alcohol-containing beverages on any day or 15 or more alcohol-containing beverages per week for men.

• Participants who have a clinically significant disorder such as cardiovascular, endocrine, respiratory, gastrointestinal, hepatobiliary, kidney, urinary, hematological, immunity, neuropsychiatric, musculoskeletal, inflammatory, and/or tumors.
• Females who are pregnant/planning to be pregnant/lactating or taking any oral contraceptives.
• Any condition that could, in the opinion of the investigator, preclude the participant's ability to successfully and safely complete the study or that may confound study outcomes