A human trial of Abeliophyllum distichum Nakai. leaf extract on decrease of body fat

A 12 weeks, randomized, double-blind, placebo-controlled human trial to evaluate the efficacy and safety of Abeliophyllum distichum Nakai. leaf extract on decrease of body fat

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0008832

Enrollment

100

Registered

2023-09-25

Start date

2021-04-26

Completion date

Unknown

Last updated

2023-10-16

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 : Abeliophyllum distichum Nakai. leaf extract group: twice a day, 2 tablets once, after meal(3 g/day, 1.5 g/day for Abeliophyllum distichum Nakai. leaf extract) Placebo group: twice

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Adult men and women aged 19 years or older and 65 years or younger at the screening test 2) A person with a BMI of 25 to 34.9 kg/m^2 at the screening test, and a body fat percentage of 25% or more for men and 30% or more for women

Exclusion criteria

Exclusion criteria: 1) If you have been taking any product that affects your weight within 1 month prior to screening test 2) Those who have undergone obesity surgery within the last 1 year 3) Those with clinically significant acute or chronic cardiovascular, endocrine, immune, respiratory, hepatobiliary, renal and urinary system, neuropsychiatric, musculoskeletal, inflammatory and gastrointestinal diseases requiring treatment 4) Diabetic patients taking oral hypoglycemic agents or insulin at the time of screening 5) Those who have a history of clinically significant hypersensitivity to the components of leaves of Abeliophyllum distichum Nakai. (However, according to the judgment of the principal investigator, patients may participate in this study considering the condition of the research subject.) 6) Those with alcohol intake of 14 units/week or more 7) Those who have received antipsychotic drug treatment within 3 months prior to screening 8) Those who have or are suspected of drug abuse 9) Those who participated in other human tirals within 3 months before the screening test

Design outcomes

Primary

Measure	Time frame
Body Fat Mass and Body Fat Percentage	—

Secondary

Measure	Time frame
anthropometric index;lipid metabolism index;lean body mass;Abdominal fat index	—

Countries

Korea, Republic of

Contacts

Public ContactJung Han Lee

Wonkwang University. Iksan Korean Medicine Hospital

milpaso@wku.ac.kr+82-63-859-2807

Outcome results