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

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04672278
• Other study ID #: BS/CR/PC/01
• Status: Completed
• Phase: N/A
• Start date: January 2, 2019
• Est. completion date: October 30, 2020

Study information

• Verified date: April 2021
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: October 30, 2020
• Est. primary completion date: October 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hyperlipidemia
• Hyperlipidemias
• Hyperlipoproteinemias
• Hypertension

Intervention

Dietary Supplement:
• Shanzha Fruit drink or placebo drink
The dosage of Shanzha fruit drink or the placebo is 3 cans per day

Locations

Country	Name	City	State
Hong Kong	The Chinese University of Hong Kong	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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	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.
Secondary	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.