Lipid-Lowering Effect and Hypotensive Effect of Shanzha Fruit Drink in Patients

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized, Double-Blind, Placebo-Controlled Cross-Over Study to Evaluate the Safety, Lipid-Lowering Effect and Hypotensive Effect of Shanzha Fruit Drink in Patients With Mild to Moderate Hyperlipidemia

Conditions
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Hyperlipidemia, Hypertension

Intervention / Treatment
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* Dietary Supplement: Shanzha Fruit drink or placebo drink


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: • Total Cholesterol between 200-300 mg/dl (5.2-7.8 mmol/l). Mean plasma triglyceride >= 4.5 mmol/l. Diastolic blood pressure 95-100 mm Hg and/or Systolic blood pressure 130-150 mm Hg. Be able to give written informed consent prior to study start and comply with study requirements. Exclusion Criteria: • Total Cholesterol between 200-300 mg/dl (5.2-7.8 mmol/l). Mean plasma triglyceride < 4.5 mmol/l. Diastolic blood pressure 95-100 mm Hg and/or Systolic blood pressure 130-150 mm Hg. Be able to give written informed consent prior to study start and comply with study requirements.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br> | Dietary Supplement: Shanzha Fruit drink or placebo drink<br>* The dosage of Shanzha fruit drink or the placebo is 3 cans per day<br>* Other names: placebo;|
| Experimental: Group B<br> | Dietary Supplement: Shanzha Fruit drink or placebo drink<br>* The dosage of Shanzha fruit drink or the placebo is 3 cans per day<br>* Other names: placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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. |