Hyperlipidemia, Hypertension
Conditions
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTShanzha Fruit drink or placebo drink
The dosage of Shanzha fruit drink or the placebo is 3 cans per day
Sponsors
Chinese University of Hong Kong
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To evaluate the hypolipidemic effect of Shanzha Fruit drink in patients with hyperlipidemia | 5 months. | 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. |
| To evaluate the safety of Shanzha Fruit drink in patients with hyperlipidemia by monitoring of liver function tests. | 5 months. | Alanine transaminase (ALT) levels as the main liver function test will be measured at the start and the end of the study. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To evaluate the hypotensive effect of Shanzha Fruit Drink | 5 months. | The changes in the systolic and diastolic blood pressure from the baseline to the end of the treatment will be evaluated. |
| 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. | 5 months. | 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. |
Countries
Hong Kong
Outcome results
None listed