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

NCT ID: NCT04672278

Last Updated: 2021-04-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-02
• Study Completion Date: 2020-10-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Group A

Group Type: EXPERIMENTAL

Shanzha Fruit drink or placebo drink

Intervention Type: DIETARY_SUPPLEMENT

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

Group B

Group Type: EXPERIMENTAL

Shanzha Fruit drink or placebo drink

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

Shanzha Fruit drink or placebo drink

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

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

placebo

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chinese University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Brian Tomlinson

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

The Chinese University of Hong Kong

Hong Kong, , Hong Kong

Countries

Hong Kong

Other Identifiers

BS/CR/PC/01

Identifier Type: -

Identifier Source: org_study_id