Health Condition 1: E00-E89- Endocrine, nutritional and metabolic diseases
Conditions
Interventions
Intervention1: Aged Garlic extract: Aged garlic extract capsule to be taken once daily for 84 days
Control Intervention1: Placebo: Placebo capsule to be taken once daily for 84 days
Sponsors
Olene Life Sciences Private Limited
Eligibility
Inclusion criteria
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 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from Baseline to End of the study in Serum triglycerides Serum LDL Serum HDL cholesterol Total Cholesterol Timepoint: Day 0 Day 28 Day 56 Day 84 | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from Baseline to End of the study in Blood Pressure Fasting blood glucose Timepoint: Day 0 Day 28 Day 56 Day 84 | — |
Countries
India
Contacts
Public ContactSanjib Panda
Olene Life Sciences Private Limited
Outcome results
None listed