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Efficacy and safety of ASE(Aster spathulifolius Maxim. extract) on reducing body weight and body fat in overweight subjects; A 12week, Randomized, Double-blind, Placebo-Controlled Clinical Trial

Status Approved

First Submitted Date

2017/11/24
Registered Date

2018/01/26
Last Updated Date

2018/01/03

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CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

1. Background

Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
CRIS Registration Number	KCT0002664
Unique Protocol ID	KHNMC2017-07-011
Public/Brief Title	Efficacy and safety of ASE(Aster spathulifolius Maxim. extract) on reducing body weight and body fat in overweight subjects
Scientific Title	Efficacy and safety of ASE(Aster spathulifolius Maxim. extract) on reducing body weight and body fat in overweight subjects; A 12week, Randomized, Double-blind, Placebo-Controlled Clinical Trial
Acronym	NT_ASE
MFDS Regulated Study	No
IND/IDE Protocol	No
Registered at Other Registry	No
Healthcare Benefit Approval Status

2. Institutional Review Board / Ethics Committee

Institutional Review Board Information
Board Approval Status	Submitted approval
Board Approval Number	KHNMC2017-07-011-001
Approval Date	2017-10-10
Institutional Review Board Name	Institutional Review Board of Kyung Hee University Hospital at Gangdong
Institutional Review Board Address
Institutional Review Board Telephone
Data Monitoring Committee	No

3. Contact Details

Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
Contact Person for Principal Investigator / Scientific Queries
Name	JEONG IN KYUNG
Title	Professor
Telephone	+82-2-440-6126
Affiliation	Kyung Hee University Hospital at Gangdong
Address	Kyung Hee University Hospital at Gangdong, 892, Dongnam-ro, Gangdong-gu, Seoul, Korea
Contact Person for Public Queries
Name	JEONG IN KYUNG
Title	Professor
Telephone	+82-2-440-6126
Affiliation	Kyung Hee University Hospital at Gangdong
Address	Kyung Hee University Hospital at Gangdong, 892, Dongnam-ro, Gangdong-gu, Seoul, Korea
Contact Person for Updating Information
Name	KIM DA YOUNG
Title	Employee
Telephone	+82-2-2277-3935
Affiliation	Neonutra
Address	4F, UPA B/D, 44 Deahak-ro, Jongno-gu, Seoul, 03122, Korea

4. Status

Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
Recruitment Status by Participating Study Site 1
Study Site	Single
Overall Recruitment Status	Recruiting
Date of First Enrollment	2017-10-30 Actual
Target Number of Participant	80
Primary Completion Date	2018-08-31 , Anticipated
Study Completion Date	2018-11-30 , Anticipated
Name of Study	Newtree
Recruitment Status	Recruiting
Date of First Enrollment	2017-10-30 ,

5. Source of Monetary / Material Support

Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
1. Source of Monetary/Material Support
Organization Name	Newtree
Organization Type	Pharmaceutical Company
Project ID	KHNMC2017-07-011

6. Sponsor Organization

Sponsor Organization Information - Organization Name, Organization Type
1. Sponsor Organization
Organization Name	Newtree
Organization Type	Pharmaceutical Company

7. Study Summary

Study Summary Information
Lay Summary	This study was designed to evaluate the efficacy and safety of body weight and body fat improvement compared to placebo when consuming Aster spathulifolius Maxim extract for overweight or obese people.

Study Summary Information

Lay Summary

This study was designed to evaluate the efficacy and safety of body weight and body fat improvement compared to placebo when consuming Aster spathulifolius Maxim extract for overweight or obese people.

8. Study Design

Study Design Information - Study Type, Study Purpose, Phase, Intervention Model, Blinding/Masking, Blinded Subject, Allocation, Intervention Type, Intervention Description, Number of Arms, Arm Label, Target Number of Participant, Arm Type, Arm Description
Study Type	Interventional Study
Study Purpose	Supportive Care
Phase	Not applicable
Intervention Model	Parallel
Blinding/Masking	Double
Blinded Subject	Subject, Investigator
Allocation	RCT
Intervention Type	Dietary Supplement
Intervention Description	Take 650 mg / tablet of Aster spathulifolius Maxim. extract (350 mg / tablet) and control group (Placebo) twice a day for 12 weeks.
Number of Arms	2
Arm 1	Arm Label Aster spathulifolius Maxim. extract
	Target Number of Participant 40
	Arm Type Experimental
	Arm Description For a total of 12 weeks, Take 2 tablets 1 time a day with water
Arm 2	Arm Label Placebo
	Target Number of Participant 40
	Arm Type Placebo comparator
	Arm Description For a total of 12 weeks, Take 2 tablets 1 time a day with water

9. Subject Eligibility

Subject Eligibility Information
Condition(s)/Problem(s)	* (E00-E90)Endocrine, nutritional and metabolic diseases (E66.9)Obesity, unspecified
Rare Disease	No
Inclusion Criteria	Gender Both
	Age 20Year~70Year
	Description (1) Adult men and women aged 20 or older and younger than 70 years (2) Those with a body mass index (BMI) of 23 kg / m2 or more and less than 30 kg / m2 (3) A person who agrees to participate in the Applicable Human Body Examination and who has voluntarily signed a written consent form (or legal representative)
Exclusion Criteria	(1) Subjects with severe cerebrovascular disease (cerebral infarction, cerebral hemorrhage, etc.), heart disease (angina pectoris, myocardial infarction, heart failure, arrhythmia requiring treatment) within the last 6 months If the subject has a history but is clinically stable, he or she can participate in the test by the examiner's judgment.) (2) Uncontrolled hypertension patients (blood pressure of 160/100 mmHg or more, after 10 minutes of test subjects) (3) Diabetic patients taking fasting blood glucose levels greater than 126 mg / dl, randomized blood glucose levels greater than 200 mg / dl, or taking oral hypoglycemic agents or insulin (4) TSH not more than 0.1 uU / ml or not less than 10 uU / ml (5) Creatinine is at least twice the normal upper limit of the testing laboratory (6) AST (GOT) or ALT (GPT) is at least three times the normal upper limit of the test laboratory. (7) People who complain of severe gastrointestinal symptoms such as heartburn and indigestion (8) Drugs that affect body weight within the past month (including absorption inhibitors and appetite suppressants, health functional foods / supplements related to obesity improvement, psychiatric drugs such as depression, beta blockers, diuretics, birth control pills, steroids, Who are taking medicines to treat hyperlipidemia (9) Those who participated in the commercial obesity program within the last 3 months (10) Have participated or planned to participate in other clinical trials within the past month (11) Those who are admitted to hospital, medication or rehabilitation due to heart disease, central nervous disorder, etc. through medical history (12) A person who is judged to have trouble with the test due to excessive alcohol consumption (13) Those who are judged to be unable to exercise due to musculoskeletal disorders (14) A person who is pregnant or who has a pregnancy plan during the period of the test (15) Any person who is found to be unsuitable for any other reason
Healthy Volunteers	Yes

10. Outcome Measure(s)

Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
Primary Outcome(s) 1
Type of Primary Outcome	/Safety/Efficacy
Outcome	Changes in body fat through DEXA(Dual Energy X-Ray Absorptiometry) after 12 weeks compared to baseline
Timepoint	Visit 2, 4
Primary Outcome(s) 2
Outcome	Changes in visceral fat area, subcutaneous fat area, total abdominal fat area, visceral / subcutaneous fat area ratio by CT after 12 weeks compared to baseline
Timepoint	Visit 2, 4
Secondary Outcome(s) 1
Outcome	Body weight, body fat mass through bio-impedance devices
Timepoint	Visit 1,3,4
Secondary Outcome(s) 2
Outcome	Waist circumference, hip circumference, waist / hip circumference ratio
Timepoint	Visit 2,3,4
Secondary Outcome(s) 3
Outcome	body mass index
Timepoint	Visit 1,3,4
Secondary Outcome(s) 4
Outcome	Body fat through DEXA(Dual Energy X-Ray Absorptiometry)
Timepoint	Visit 2, 4
Secondary Outcome(s) 5
Outcome	Total Cholesterol, HDL-Cholesterol, LDL-Cholesterol, Triglyceride
Timepoint	Visit 1,3,4
Secondary Outcome(s) 6
Outcome	hs-CRP, Fasting insulin, HOMA-IR, HOMA-β
Timepoint	Visit 1,3,4
Secondary Outcome(s) 7
Outcome	leptin, adiponectin, TNF-α, IL-6
Timepoint	Visit 1,3,4

11. Study Results and Publication

Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
Result Registered

12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
Sharing Statement	Not provided at time of Registration

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