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

The Chinese University of Hong Kong

Status: Completed

Conditions: Hypertension; Hyperlipidemia

Treatments: Dietary Supplement: Shanzha Fruit drink or placebo drink

Study type: Interventional

Funder types: Other

Identifiers

NCT04672278

BS/CR/PC/01

Details and patient eligibility

About

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.

Enrollment: 72 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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72 participants in 2 patient groups

Group A

Experimental group

Treatment:

Dietary Supplement: Shanzha Fruit drink or placebo drink

Group B

Experimental group

Treatment:

Dietary Supplement: Shanzha Fruit drink or placebo drink