Clinical trial NCT05404217: Clinical Trial to Investigate the Efficacy and Safety of LN-OS-22 on Oxidative Stress and Systemic Inflammation in Overweight and Obese Population.
Official title: A Randomized, Double-blind, Placebo-controlled Parallel-group Clinical Trial to Investigate the Efficacy and Safety of LN-OS-22 on Oxidative Stress and Systemic Inflammation in Overweight and Obese Population.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oxidative Stress
Lead sponsor: Vedic Lifesciences Pvt. Ltd.
Sponsor class: INDUSTRY
First posted: 2022-06-03
Enrollment: 64
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, double-blind, placebo-controlled parallel-group
Primary purpose: OTHER

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 ranging from ≥25.0 kg/m2 and ≤ 34.9 kg/m2 . The antioxidant effect of the 56 days of oral administration of the extract (1000 mg/day) will be primarily assessed by change in the level of 8-isoprostane from baseline to the end of the study and the anti-inflammatory activity of the extract will be investigated by the change in the level of CRP and IL-6. In addition, the effect on lipid peroxidation and DNA damage will be assessed by serum level of MDA before and after 2 months of extract administration. Further, metabolic endotoxemia will be assessed by the change in the plasma level of lipopolysaccharides. Weight and waist circumference are included as secondary outcomes as the clinical indicators of reduction in oxidative stress and inflammation. Overweight and obesity significantly impact the health-related quality of life31 in the affected individuals and flavonoids have previously been shown to improve the quality of life in controlled clinical studies therefore, Investigator included health-related quality of life as a secondary objective of the study. The safety of the 2-month administration of the extract will be examined by a change in the vitals, liver, and kidney function biomarkers (SGOT, SGPT, ALP, and creatinine).


Eligibility criteria: Inclusion Criteria:

1. Males and females aged ≥30 -≤60 years.
2. No history of systemic infection as assessed by normal total leucocyte count.
3. Overweight and obese participants (at high risk of oxidative stress and inflammation) identified as BMI ≥ 25.0 kg/m2 and ≤ 34.9 kg/m2
4. 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.
5. Individuals physically inactive for 1/3rd of the wake time as per the Longitudinal Aging Study Amsterdam (LASA) sedentary behavior questionnaire
6. Non-smokers (Past smokers can be allowed if they have abstinence for a minimum of 2 years)
7. 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)
8. Participants who are literate enough to read and understand the consent form and provide voluntary consent.
9. Participants who can give written informed consent and willing to participate in the study and comply with its procedures.

Exclusion Criteria:

1. Known sensitivity to the investigational product or any excipients of the drug product.
2. Known case of lactose intolerance.
3. Known case of type I diabetes.
4. Presence of uncontrolled type II diabetes mellitus (indicated by HbA1c ≥ 6.5).
5. Presence of uncontrolled hypertension (defined as Systolic Blood Pressure (SBP) ≥ 140 mm Hg and/or Diastolic Blood Pressure (DBP) ≥ 90 mm Hg).
6. Presence thyroid dysfunction (defined as thyroid stimulating hormone (TSH) level \< 0.4 to \> 4.2 mIU/L).
7. 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.
8. 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.
9. History of any significant neurological and psychiatric condition which may affect the participation and inference of the study's endpoints.
10. History of use of anti-inflammatory therapies for any ailments within 7 days prior to randomization.
11. Participation in other clinical trials in the last 3 months prior to screening
12. 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.
13. Participants who have a clinically significant disorder such as cardiovascular, endocrine, respiratory, gastrointestinal, hepatobiliary, kidney, urinary, hematological, immunity, neuropsychiatric, musculoskeletal, inflammatory, and/or tumors.
14. Females who are pregnant/planning to be pregnant/lactating or taking any oral contraceptives.
15. 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

Primary outcomes:
measure: Oxidative stress
timeFrame: days 0, day 28, and day 56.
Secondary outcomes:
measure: Systemic inflammation CRP and IL - 6
timeFrame: days 0, day 28, and day 56.
measure: Metabolic endotoxemia
timeFrame: days 0, and day 56.
measure: Body weight
timeFrame: days 0, day 28, and day 56.
measure: Waist circumference
timeFrame: days 0, day 28, and day 56.
measure: Impact of Weight on Quality of Life-Lite-Clinical Trials
timeFrame: days 0, day 28, and day 56.
Other outcomes:
Locations:
city: Mumbai
country: India
facility: Ayush Nursing Home
state: Maharashtra
city: Mumbai
country: India
facility: Dr. Awate's Clinic
state: Maharashtra
city: Mumbai
country: India
facility: Metabol-Lifestyle metabolic syndrome clinic
state: Maharashtra
Study officials:
affiliation: Vedic Lifesciences Pvt. Ltd.
name: Dr Shalini Srivastava, MD medicine
role: STUDY_DIRECTOR
References: