A Randomized, Clinical Study to evaluate Efficacy and Safety of ONLP-15 in the Management of Cardio Vascular disease risk factors

Not Applicable

• Conditions: Health Condition 1: E00-E89- Endocrine, nutritional and metabolic diseases

• Registration Number: CTRI/2022/02/039981
• Lead Sponsor: Olene Life Sciences Private Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 21 February 2022

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1 Male or female subjects between 30 to 65 years of age

2 Ability to understand the risks benefits of the protocol

3 Female subjects of childbearing potential must be using a medically acceptable form of birth control. Female subjects of non childbearing potential must be amenorrheic for at least 1 years or had a hysterectomy and/or bilateral oophorectomy

4 Serum triglycerides > 115mg/dL and less than < 199 mg/dL

5 If Former smoker (previously smoked >=10 cigarettes/day for at least 1 year, cessation for at least 6 months

6 Willing to give written informed consent and willing to comply with trial protocol

Exclusion Criteria

Pregnant or breast feeding women

Serum glucose levels higher than 126 mg/dL

Use of cholesterol lowering medication or supplements

Use of blood pressure lowering medication

Subjects having abnormal liver or kidney function tests ALT or AST more than 2 times the upper limit of normal elevated Creatinine, males more than 125 μmol per L females more than 110 μmol per L renal insufficiency thyroid or other endocrine disease

Any other condition that, in the opinion of the investigator would adversely affect the subject s ability to complete the study or its measures

Hypersensitivity to any of the ingredient used in the study supplements

Alcohol consumption exceeding the definition of moderate drinking 2 drinks per day for men or 1 drink per day for women

Subjects participated in any investigational study medication within thirty days prior to screening

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change from Baseline to End of the study in <br/ ><br>Serum triglycerides <br/ ><br>Serum LDL <br/ ><br>Serum HDL cholesterol <br/ ><br>Total Cholesterol <br/ ><br>Timepoint: Day 0 Day 28 Day 56 Day 84

Secondary Outcome Measures

Name	Time	Method
Change from Baseline to End of the study in <br/ ><br>Blood Pressure <br/ ><br>Fasting blood glucose <br/ ><br>Timepoint: Day 0 Day 28 Day 56 Day 84