A human study to evaluate safety and effective dose of Seapolynol (Ecklonia cava extract) on postprandial glucose level in healthy subjects

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0001346

Enrollment

Registered

2015-01-14

Start date

2014-12-23

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 : Subjects were randomly assigned to placebo group, Seapolynol(Ecklonia cava extract)low group, Seapolynol(Ecklonia cava extract)medium group, Seapolynol(Ecklonia cava extract)high

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Subject who voluntarily agrees to participate and sign in informed consent form 2) Age: 20 years = Age < 40 years 3) fasting glucose < 126mg/dL 4) Subject who can participate all visits after rondomization

Exclusion criteria

Exclusion criteria: 1) Continuous consumption of drug that affect glucose metabolism, inflammation, antioxidative capacity and lipid metabolism or dietary supplement or oriental medicine or within 4 weeks before the first visit 2) Consumption of anticoagulant within 4 weeks before the first visit 3) BMI=18.5 or BMI=30 4) Following diseases : ? Diabetes, liver dysfunction, renal dysfunction, cardiovascular diseases (hypertension, stroke, etc.), thyroid diseases ? Mental diseases such as depression, schizophrenia, alcoholism , drug addiction ? Wasting diseases such as malignant tumor etc., and severe muscular skeletal disease ? asthma and allergic diseases 5) Chronic smoker (= 20 cigarettes / day) 6) Excessive exercise (= 10 hours / week) 7) Change of body weight more than 4 kg or weight control within 4 weeks before the first visit 8) Subjects with hypersensitivity to test materials 9) Participation in other human study within 4 weeks before the first visit 10) Pregnant or lactating women 11) Any condition that the principal investigator believes may put the subjects at undue risk

Design outcomes

Primary

Measure	Time frame
glucose, iAUC, AST, ALT, MDA etc	—

Secondary

Measure	Time frame
insulin etc	—

Countries

Korea, Republic of

Contacts

Public ContactHyoJin Lee

Ewha Womans University

Outcome results