Clinical trial for the evaluation of the efficacy and safety of the extracts of lotus leaf complex on blood lipid levels.

A 12 week, randomized, placebo-controlled clinical trial for the evaluation of the efficacy and safety of the extracts of lotus leaf complex in accordance with medical nutrition therapy on blood lipid levels in subjects with borderline dyslipidemia.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0003136

Enrollment

Registered

2018-08-28

Start date

2013-08-19

Completion date

Unknown

Last updated

2019-03-11

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 : Placebo: placebo twice/day , 2 tablet/1 time, total 4 tablets intakes Placeb+MNT: placebo twice/day , 2 tablet/1 time, total 4 tablets intakes+Nutrition intervention LTC: Lotus an

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: A borderline dyslipidemia diagnosed with one of abnormalities of serum lipid level followed total cholesterol (200-239 mg/dl) or LDL-cholesterol (130-159 mg/dl) or triglyceride (150-199 mg/dl).

Exclusion criteria

Exclusion criteria: 1) subjects who were pregnant and breastfeeding or participating in other clinical trials within 3 months, 2) subjects with secondary dyslipidemia due to hypothyroidism, nephritic syndrome or other diseases, 3) subjects with cardiovascular diseases (angina pectoris, myocardial infarction and coronary artery bypass graft), 4) subjects who had medical history of pancreatic diseases (e.g. pancreatitis or deficiency in pancreatic), 5) subjects whose AST/ALT level was more than 3 times higher than the upper limit of the normal, 6) subjects who were receiving hormone treatment, 7) subjects of uncontrolled high blood pressure (over 170/100mmHg, when screened), 8) subjects who had diabetes, which is hard to control blood glucose level, 9) subjects who had been addicted to drugs or alcohol before, 10) subjects who were illiteracy and 11) subjects who were considered as inappropriate.

Design outcomes

Primary

Measure	Time frame
Triacylglycerol (TG), total cholesterol, high-density lipoprotein (HDL) cholesterol, low-density lipoprotein (LDL) cholesterol,	—

Secondary

Measure	Time frame
Superoxide dismutase (SOD), and malondialdehyde (MDA), Catalase;Aspartic acid transaminase (AST), Alanine transaminase (ALT), ?- glutamyl transpeptidase (?-GT)	—

Countries

Korea, Republic of

Contacts

Public ContactHansongyi Lee

Kyung Hee University

flowerlhsy@gmail.com+82-2-969-7715

Outcome results