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

NCT04672278 | Completed

• 1 other identifier: BS/CR/PC/01
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Hyperlipidemia; Hypertension

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• To evaluate the hypotensive effect of Shanzha Fruit Drink

  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.

  5 months.

Study Arms (2)

Group A

EXPERIMENTAL

Dietary Supplement: Shanzha Fruit drink or placebo drink

Group B

EXPERIMENTAL

Dietary Supplement: Shanzha Fruit drink or placebo drink

Interventions

Shanzha Fruit drink or placebo drink DIETARY_SUPPLEMENT

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

Also known as: placebo

Group A; Group B

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

The Chinese University of Hong Kong

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Hyperlipidemias; Hypertension

Condition Hierarchy (Ancestors)

Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 14, 2020
• First Posted: December 17, 2020
• Study Start: January 2, 2019
• Primary Completion: October 30, 2020
• Study Completion: October 30, 2020
• Last Updated: April 23, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)