The Efficacy Evaluation of CHOLESWISE Pressed Candy on Cardiovascular Health

NCT05182788 | Completed

• 1 other identifier: 2021-KY-24-01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cardiovascular Diseases

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (2)

• Change from baseline in blood glucose

  Days 1, 28, and 56

• Change from baseline in blood hs-CRP

  Days 1 and 56

Study Arms (2)

Placebo pressed candy

PLACEBO COMPARATOR

Dietary Supplement: Placebo pressed candy

CHOLESWISE pressed candy

EXPERIMENTAL

Dietary Supplement: CHOLESWISE pressed candy

Interventions

Placebo pressed candy DIETARY_SUPPLEMENT

consume 2 tablets per day for 8 weeks

Placebo pressed candy

CHOLESWISE pressed candy DIETARY_SUPPLEMENT

consume 2 tablets per day for 8 weeks

Also known as: Natto combined Phyllanthus emblica pressed candy

CHOLESWISE pressed candy

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• TCI Co., Ltd.: lead

Study Sites (1)

Shanghai Fengxian District Central Hospital

Shanghai, 201499, China

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2022
• First Posted: January 10, 2022
• Study Start: June 9, 2022
• Primary Completion: September 30, 2022
• Study Completion: March 31, 2023
• Last Updated: May 18, 2023

Record last verified: 2023-05

Locations

CN (1)