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

Primary Purpose

Hyperlipidemia, Hypertension

Status
Completed
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Shanzha Fruit drink or placebo drink
Sponsored by
Chinese University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hyperlipidemia

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The Chinese University of Hong Kong

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Group A

Group B

Arm Description

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
December 14, 2020
Last Updated
April 21, 2021
Sponsor
Chinese University of Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT04672278
Brief Title
Lipid-Lowering Effect and Hypotensive Effect of Shanzha Fruit Drink in Patients
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
January 2, 2019 (Actual)
Primary Completion Date
October 30, 2020 (Actual)
Study Completion Date
October 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperlipidemia, Hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
72 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Experimental
Arm Title
Group B
Arm Type
Experimental
Intervention Type
Dietary Supplement
Intervention Name(s)
Shanzha Fruit drink or placebo drink
Other Intervention Name(s)
placebo
Intervention Description
The dosage of Shanzha fruit drink or the placebo is 3 cans per day
Primary Outcome Measure Information:
Title
To evaluate the hypolipidemic effect of Shanzha Fruit drink in patients with hyperlipidemia
Description
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.
Title
To evaluate the safety of Shanzha Fruit drink in patients with hyperlipidemia by monitoring of liver function tests.
Description
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 Outcome Measure Information:
Title
To evaluate the hypotensive effect of Shanzha Fruit Drink
Description
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.
Title
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.
Description
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
The Chinese University of Hong Kong
City
Hong Kong
Country
Hong Kong

12. IPD Sharing Statement

Plan to Share IPD
No

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

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