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

Chinese University of Hong Kong72 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Hyperlipidemia Hypertension

Interventions

Shanzha Fruit drink or placebo drinkDIETARY_SUPPLEMENT

The dosage of Shanzha fruit drink or the placebo is 3 cans per day

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (1)

The Chinese University of Hong Kong

Hong Kong, Hong Kong

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 5 months.

Secondary Outcomes

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.

Time frame: 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.

Time frame: 5 months.

Data from ClinicalTrials.gov

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