A clinical trial to investigate the efficacy and safety of Investigational product (LN-OS-22) on oxidative stress and systemic inflammation in overweight and obese population.
- Conditions
- Health Condition 1: E663- Overweight
- Registration Number
- CTRI/2022/06/043394
- Lead Sponsor
- Vedic Lifesciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 64
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.
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 < 0.4 to > 4.2 mIU/L).
7. Participants with moderate to severe anemia defined as hemoglobin <10 gm/dL in females and < 11 gm/dL in 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 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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. <br/ ><br>Timepoint: Day 0, 28, and 56
- Secondary Outcome Measures
Name Time Method