Status:
COMPLETED
Clinical Trial to Investigate the Efficacy and Safety of LN-OS-22 on Oxidative Stress and Systemic Inflammation in Overweight and Obese Population.
Lead Sponsor:
Vedic Lifesciences Pvt. Ltd.
Conditions:
Oxidative Stress
Eligibility:
All Genders
30-60 years
Phase:
NA
Brief Summary
The present clinical investigation has been proposed to further substantiate the evidence of the antioxidant and anti-inflammatory activity of the extract in the healthy adult population with BMI rang...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 16 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 13 2023
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT05404217
Start Date
June 16 2022
End Date
March 13 2023
Last Update
April 6 2023
Active Locations (3)
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1
Ayush Nursing Home
Mumbai, Maharashtra, India, 400067
2
Dr. Awate's Clinic
Mumbai, Maharashtra, India, 400067
3
Metabol-Lifestyle metabolic syndrome clinic
Mumbai, Maharashtra, India, 400086