A randomized, double-blind, placebo-controlled trial to evaluate the effect on plasma cholesterol and safety of deep sea water

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0003702

Enrollment

Registered

2019-04-02

Start date

2018-02-20

Completion date

Unknown

Last updated

2019-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Dietary Supplement : Test group: 440 ml of deep sea water, taking oral medication twice a day for 8 weeks Control: 440ml of contrast food, taking oral medication twice a day for 8 weeks

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Men and women aged 19 ~ 80 2. Serum total cholesterol 200 ~ 299 mg/dL

Exclusion criteria

Exclusion criteria: 1. Hypersensitivity with major or other components of test foods or clinically significant history 2. History influencing on assessing test foods (hepatobiliary, kidney, cardiovascular, endocrine, respiratory, gastrointestinal, oncologic, musculoskeletal. psychiatric, central nervous system, etc) 3. Hyperlipidemia high-risk group requiring drug administration (carotid artery disease, abdominal aortic aneurysm, diabetes mellitus, coronary artery disease, ischemic stroke, transient ischemic attacks, peripheral arterial disease) 4. systolic blood pressure = 160 mmHg or diastolic blood pressure =100 mmHg 5. Pregnant women, nursing mothers, and fertile women without proper contraceptives 6. Subjects who have taken a new drug or has changed medication capacity that may affect blood lipid concentration within the last two weeks 7. Subjects who have taken any prescription medicine or herbal medicine or over-the-counter drug (OTC) within the last two weeks is judged to have an effect on the study or on the safety of the subject by researcher 8. Subjects who have recently started taking supplements within two weeks such as Health Supplement (Monascus), phytosterol (vegetable sterol), and fish oil (ex. omega-3) that can affect the blood lipid concentration 9. Persistent heavy drinker (alcohol > 21 units/week, 1 unit = 10g of pure alcohol = 12.5mL) or heavy smoker (cigarettes > 10units/day)

Design outcomes

Primary

Measure	Time frame
total cholesterol;LDL-cholesterol	—

Secondary

Measure	Time frame
HDL-cholesterol;Triglyceride;free fatty acid;apolipoprotein A1;apolipoprotein B;lipoprotein a;hs CRP	—

Countries

Korea, Republic of

Contacts

Public ContactHojun Kim

Dongguk University

Outcome results