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

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

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 Overview

• Status: Completed
• Conditions: Hypertension; Hyperlipidemia
• Intervention / Treatment: Dietary supplement: Shanzha Fruit drink or placebo drink

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • The Chinese University of Hong Kong

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A	Dietary supplement: Shanzha Fruit drink or placebo drink; The dosage of Shanzha fruit drink or the placebo is 3 cans per day; Other Names: placebo
Experimental: Group B	Dietary supplement: Shanzha Fruit drink or placebo drink; The dosage of Shanzha fruit drink or the placebo is 3 cans per day; Other Names: placebo

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2019
• Primary Completion (Actual): October 30, 2020
• Study Completion (Actual): October 30, 2020

Study Registration Dates

• First Submitted: December 14, 2020
• First Submitted That Met QC Criteria: December 16, 2020
• First Posted (Actual): December 17, 2020

Study Record Updates

• Last Update Posted (Actual): April 23, 2021
• Last Update Submitted That Met QC Criteria: April 21, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Dyslipidemias; Hyperlipidemias; Hyperlipoproteinemias
• Other Study ID Numbers: BS/CR/PC/01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No