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

Not Applicable

Completed

• Conditions: Hypertension; Hyperlipidemia
• Interventions: Dietary Supplement: Shanzha Fruit drink or placebo drink

• Registration Number: NCT04672278
• Lead Sponsor: Chinese University of Hong Kong

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-02
• Primary Completion: 2020-10-30
• Study Completion: 2020-10-30
• Study First Submitted: 2020-12-14
• Study First Submitted QC: 2020-12-16
• Study First Posted: 2020-12-17
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-21
• Last Update Posted: 2021-04-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Group B	Shanzha Fruit drink or placebo drink	-
Group A	Shanzha Fruit drink or placebo drink	-

Primary Outcome Measures

Name	Time	Method
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.
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.

Secondary Outcome Measures

Name	Time	Method
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.
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.

Trial Locations

Locations (1)

The Chinese University of Hong Kong; 🇭🇰 Hong Kong, Hong Kong