Health Condition 1: E663- Overweight
Conditions
Interventions
Intervention1: LN-OS-22: Dose and route: Two capsules orally once daily
Regimen: To be taken with a glass of milk after breakfast for 56 days
Control Intervention1: Maltodextrin: Dose and route: Two c
Sponsors
Vedic Lifesciences
Eligibility
Inclusion criteria
Inclusion criteria: 1. Males and females aged = 30 - = 60 years. 2. No systemic infection as assessed by normal total leucocyte count. 3. Overweight and obese participants (at high risk of oxidative stress and inflammation) identified by body mass index (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: i Waist circumference (WC) more than 102 cm for males and 88 cm for females ii Blood pressure (BP) more than 130/85 mmHg iii Fasting triglyceride (TG) level = 150 mg/dl iv Fasting high-density lipoprotein cholesterol (HDL-C) level = 40 mg/dl for males and 50 mg/dl for females v Fasting blood glucose (FBG) = 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 consumption of study products, blood 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
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 glycosylated hemoglobin (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 4.2 mIU/L). 7. Participants with moderate to severe anemia defined as hemoglobin 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 ailment 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: i Use of recreational drugs (such as cocaine, methamphetamine, marijuana, etc.)/Nicotine dependence. ii 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the efficacy of IP consumption on oxidative stress as assessed by change in serum levels of 8-isoprostane (8-iso-PGF2a) from baseline to the end of the study compared to placebo. Timepoint: Day 0, 28, and 56 | — |
Secondary
| Measure | Time frame |
|---|---|
| Anthropometric indices as assessed by change in weight and waist circumference (WC) from baseline.Timepoint: Day 0, 28, and 56;Laboratory parameters - Serum Alkaline Phosphatase (ALP), Serum Glutamic Oxaloacetic Transaminase (SGOT), Serum Glutamic Pyruvic Transaminase (SGPT), and Serum Creatinine on baseline and end of the study visit.Timepoint: Day 0, and 56;Metabolic endotoxemia as assessed by change in plasma lipopolysaccharide (LPS) levels post-high-fat diet from baselineTimepoint: Day 0, and 56;Occurrence of adverse events (AE) throughout the study.Timepoint: day 0 to day 56;Quality of life as assessed by change in scores of IWQOL-Lite-CT from baseline compared to placebo.Timepoint: Day 0, 28, and 56;Systemic inflammation as assessed by change in ? Serum C-reactive protein (CRP) levels from baseline.Timepoint: Day 0, 28, and 56;Systemic inflammation as assessed by change in ? Serum levels of pro-inflammatory cytokine interleukin-6(IL-6) levels from baselineTimepoint: Day 0, 28, and 56;To evaluate the efficacy of IP consumption on the following parameters compared to placebo: • Lipid peroxidation and DNA oxidative damage as assessed by change in serum levels of malondialdehyde (MDA) from baselineTimepoint: Day 0, 28, and 56;To evaluate the safety of IP consumption on the following parameters compared to placebo: • Vital signs (blood pressure (BP) and pulse rate (PR)) on each visit. Timepoint: Day 0, 28, and 56 | — |
Countries
India
Contacts
Public ContactDr Sonali Ghosh
Vedic Lifesciences Pvt. Ltd.
Outcome results
None listed