Skip to main content
OpenTrials
Completed

NCT Number: NCT04672278

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hyperlipidemia Cardiovascular Diseases Dyslipidemias Hyperlipidemias Hypertension Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Chinese University of Hong Kong

Hong Kong

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Shanzha Fruit drink or placebo drink

Dietary Supplement

The dosage of Shanzha fruit drink or the placebo is 3 cans per day

Other names: placebo

Primary outcomes

  1. To evaluate the hypolipidemic effect of Shanzha Fruit drink in patients with hyperlipidemia

    Time frame: 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.

  2. To evaluate the safety of Shanzha Fruit drink in patients with hyperlipidemia by monitoring of liver function tests.

    Time frame: 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 outcomes

  1. To evaluate the hypotensive effect of Shanzha Fruit Drink

    Time frame: 5 months.

    The changes in the systolic and diastolic blood pressure from the baseline to the end of the treatment will be evaluated.

  2. 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.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Dec 17, 2020
Registry last updated
Apr 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.