The Efficacy Evaluation of CHOLESWISE Pressed Candy on Cardiovascular Health

Not Applicable

Completed

• Conditions: Cardiovascular Diseases
• Interventions: Dietary Supplement: Placebo pressed candy; Dietary Supplement: CHOLESWISE pressed candy

• Registration Number: NCT05182788
• Lead Sponsor: TCI Co., Ltd.

Brief Summary

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

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 Timeline

• Study First Submitted: 2022-01-04
• Study First Submitted QC: 2022-01-04
• Study First Posted: 2022-01-10
• Study Start: 2022-06-09
• Primary Completion: 2022-09-30
• Study Completion: 2023-03-31
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-17
• Last Update Posted: 2023-05-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo pressed candy	Placebo pressed candy	-
CHOLESWISE pressed candy	CHOLESWISE pressed candy	-

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Shanghai Fengxian District Central Hospital; 🇨🇳 Shanghai, China