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

Not Applicable

Completed

• Conditions: Endocrine, nutritional and metabolic disease

• Registration Number: KCT0003702
• Lead Sponsor: Dongguk University Ilsan Oriental Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 23 April 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 78

Inclusion Criteria

1. Men and women aged 19 ~ 80
2. Serum total cholesterol 200 ~ 299 mg/d

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)

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
total cholesterol;LDL-cholesterol

Secondary Outcome Measures

Name	Time	Method
HDL-cholesterol;Triglyceride;free fatty acid;apolipoprotein A1;apolipoprotein B;lipoprotein a;hs CRP