The Efficacy Evaluation of CHOLESWISE Pressed Candy on Cardiovascular Health

The Efficacy Evaluation of CHOLESWISE Pressed Candy on Cardiovascular Health, a Single Center, Randomized, Doubld-Blind, Placebo Controlled Study

To assess the efficacy evaluation of CHOLESWISE Pressed Candy on cardiovascular disease risk factors

Study Overview

• Status: Completed
• Conditions: Cardiovascular Diseases
• Intervention / Treatment: Dietary supplement: Placebo pressed candy; Dietary supplement: CHOLESWISE pressed candy

Detailed Description

This is a single center, randomized, double-blind and placebo controlled study. Subjects are informed to consume the samples every day for 8 weeks.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai, China, 201499
    • Shanghai Fengxian District Central Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Age ≥ 30 years old, no gender limit;
• Patients with high blood pressure (systolic blood pressure> 120 mmHg or diastolic blood pressure> 80 mmHg) or high blood lipids (TC ≥ 5.18 mmol/L or TG ≥ 1.7 mmol/L), and no medication is used;
• Fully understand the purpose, benefits, potential risks and side effects of this research, and can objectively cooperate with doctors to complete the examination and assessment of diseases and physical conditions;
• People who voluntarily agree and sign an informed consent form.

Exclusion Criteria:

• People with a history of dyspepsia would affect the absorption of the test product;
• Any situation that may affect trial process, including difficult-to-control organic disease or infection, unstable angina pectoris, congestive heart failure and other severe disease;
• People with symptomatic and difficult-to-control neurological, mental diseases or mental disorders;
• Pregnant or breast-feeding women or women who have a positive result on a pregnancy test;
• Allergic to the components of the test product;
• Take supplementary foods and health supplements with the same efficacy two weeks before and during the test.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo pressed candy	Dietary supplement: Placebo pressed candy; consume 2 tablets per day for 8 weeks
Experimental: CHOLESWISE pressed candy	Dietary supplement: CHOLESWISE pressed candy; consume 2 tablets per day for 8 weeks; Other Names: Natto combined Phyllanthus emblica pressed candy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in blood pressure (systolic blood pressure, diastolic blood pressure)	Blood pressure will be measured at the beginning, 4-week, and 8-week time points.	Days 1, 28, and 56
Change from baseline in blood lipid (total-Cholesterol, triglyceride, HDL-C, LDL-C)	Blood lipid will be measured at the beginning, 4-week, and 8-week time points.	Days 1, 28, and 56
Change from baseline in blood coagulation factor (factor VII, fibrinogen)	Blood coagulation factor will be measured at the beginning, 4-week, and 8-week time points.	Days 1, 28, and 56
Change from baseline in arteriosclerosis	Arteriosclerosis will be measured by B-scan ultrasonography at the beginning and 8-week time points.	Days 1 and 56

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in blood glucose	Blood glucose will be measured at the beginning, 4-week, and 8-week time points.	Days 1, 28, and 56
Change from baseline in blood hs-CRP	Blood hs-CRP will be measured at the beginning 8-week time points.	Days 1 and 56

Collaborators and Investigators

• Sponsor: TCI Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): June 9, 2022
• Primary Completion (Actual): September 30, 2022
• Study Completion (Actual): March 31, 2023

Study Registration Dates

• First Submitted: January 4, 2022
• First Submitted That Met QC Criteria: January 4, 2022
• First Posted (Actual): January 10, 2022

Study Record Updates

• Last Update Posted (Actual): May 18, 2023
• Last Update Submitted That Met QC Criteria: May 17, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: 2021-KY-24-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No