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Completed

NCT Number: NCT05182788

The Efficacy Evaluation of CHOLESWISE Pressed Candy on Cardiovascular Health

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

Completed

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Key information

Age range

30 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shanghai Fengxian District Central Hospital

Shanghai, 201499, China

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Placebo pressed candy

Dietary Supplement

consume 2 tablets per day for 8 weeks

CHOLESWISE pressed candy

Dietary Supplement

consume 2 tablets per day for 8 weeks

Other names: Natto combined Phyllanthus emblica pressed candy

Primary outcomes

  1. Change from baseline in blood pressure (systolic blood pressure, diastolic blood pressure)

    Time frame: Days 1, 28, and 56

    Blood pressure will be measured at the beginning, 4-week, and 8-week time points.

  2. Change from baseline in blood lipid (total-Cholesterol, triglyceride, HDL-C, LDL-C)

    Time frame: Days 1, 28, and 56

    Blood lipid will be measured at the beginning, 4-week, and 8-week time points.

  3. Change from baseline in blood coagulation factor (factor VII, fibrinogen)

    Time frame: Days 1, 28, and 56

    Blood coagulation factor will be measured at the beginning, 4-week, and 8-week time points.

  4. Change from baseline in arteriosclerosis

    Time frame: Days 1 and 56

    Arteriosclerosis will be measured by B-scan ultrasonography at the beginning and 8-week time points.

Secondary outcomes

  1. Change from baseline in blood glucose

    Time frame: Days 1, 28, and 56

    Blood glucose will be measured at the beginning, 4-week, and 8-week time points.

  2. Change from baseline in blood hs-CRP

    Time frame: Days 1 and 56

    Blood hs-CRP will be measured at the beginning 8-week time points.

Sponsors and collaborators

Lead sponsor

TCI Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Jan 10, 2022
Registry last updated
May 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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