NCT05404217

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

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.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: Vedic Lifesciences Pvt. Ltd. · Industry
• Sex: All
• Age: 30 Years – 60 Years
• Healthy volunteers: Accepted

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).

Conditions

• Oxidative Stress

Interventions

Type	Name	Description
OTHER	LN-OS-22	2 capsules orally once a day to be taken with a glass of milk after breakfast for 56 days
OTHER	Maltodextrin	2 capsules orally once a day to be taken with a glass of milk after breakfast for 56 days

Timeline

• Start date: 2022-06-16
• Primary completion: 2023-03-13
• Completion: 2023-03-13
• First posted: 2022-06-03
• Last updated: 2023-04-06

Locations

3 sites across 1 country: India