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This is a single-center, randomized, double-blind, placebo-controlled, cross-over study. Subjects who meet the inclusion/exclusion criteria will be randomly and alternatively assigned to receive Shanzha fruit drink or placebo drink in the first 2 months or the last two months of the 5 months study period. In between the first and second treatment period, all patients will enter a Washout Period of 4 weeks and during which time patients should not receive any of the study functional fruit drink.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental |
| |
| Group B | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Shanzha Fruit drink or placebo drink | Dietary Supplement | The dosage of Shanzha fruit drink or the placebo is 3 cans per day |
|
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the hypolipidemic effect of Shanzha Fruit drink in patients with hyperlipidemia | The lipid profile including total cholesterol, HDL cholesterol, LDL-cholesterol and triglycerides will be measured at the start and the end of the study and changes from the baseline to the end of the treatment will be evaluated. | 5 months. |
| To evaluate the safety of Shanzha Fruit drink in patients with hyperlipidemia by monitoring of liver function tests. | Alanine transaminase (ALT) levels as the main liver function test will be measured at the start and the end of the study. | 5 months. |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the hypotensive effect of Shanzha Fruit Drink | The changes in the systolic and diastolic blood pressure from the baseline to the end of the treatment will be evaluated. | 5 months. |
| To evaluate the safety of Shanzha Fruit drink in patients with hyperlipidemia by recording any adverse events reported by the study subjects or noted by the investigator. |
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Inclusion Criteria:
• Total Cholesterol between 200-300 mg/dl (5.2-7.8 mmol/l).
Exclusion Criteria:
• Total Cholesterol between 200-300 mg/dl (5.2-7.8 mmol/l).
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Chinese University of Hong Kong | Hong Kong | Hong Kong |
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| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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Any adverse events reported by the study subjects or noted by the investigator will be recorded at all the study visits after the initial study visit. |
| 5 months. |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |