Serum LDL level between 100 mg/dL – 190 mg/dL (100 mg/dL<LDL<190 mg/dL)
Conditions
Interventions
- The study will be a randomized, double-blinded, placebo-controlled clinical trial. It will be conducted at the Sri Jayewardenepura General Hospital, Sri Lanka for a period of 3 months, assessing the
Sponsors
SDS Spices (PVT) LTD
Eligibility
Inclusion criteria
Inclusion criteria: * Age between 18-70 years * Both male and female * LDL level; between 100 and 190 mg/dL (100 mg/dL < LDL < 190mg/dL)
Exclusion criteria
Exclusion criteria: • Participants with an allergy to cinnamon • Already on cinnamon or any other nutritional / herbal / ayurvedic supplements. • Lactation, pregnancy or unwillingness to use an effective form of birth control for women of childbearing years • Any form of malignancy at present or in the past • Blood dyscrasias • Estimated Glomerular Filtration Rate (eGFR) 300 mg/dL
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in low density lipo-protein (LDL) levels from baseline to final follow-up at three months post randomization. [end of 3 months ] | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in other lipid profile parameters (HDL, total cholesterol and triglycerides) from baseline to end of study visit [At the end of 3 months from initiating the intervention] Changes in Fasting Blood Sugar (FBS) and HbA1c from baseline to end of study visit [At the end of 3 months from initiating the intervention] Changes in anthropometric parameters [Weight, waist circumference, hip circumference, and mid arm circumference] from baseline to end of study visit [ At each monthly follow up visit ] Change in systolic blood pressure and diastolic blood pressure from baseline to end of study visit. [ At each monthly follow up visit ] Potential effects of regular administration of C. zeylanicum extracts on liver and kidney function \ from baseline to end of study visit. Liver profile tests include Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP). Renal profile tests include Serum creatinine, albumin creatinine ratio (ACR), Glomerular Filtration Rate (eGFR), electrolytes-Na, K, Cl [ At each monthly follow up visit ] Self-reported side effects in participants of the study from baseline to end of study visit. [At each monthly follow up visit] | — |
Countries
Sri Lanka
Contacts
Public ContactDr Dimuthu Muthukuda
Consultant Endocrinologist
Outcome results
None listed