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A human study to evaluate the efficacy and safety of rice bran extract on climacteric symptoms in perimenopausal and postmenopausal women

Status Approved

First Submitted Date

2018/10/08
Registered Date

2018/10/19
Last Updated Date

2019/04/09

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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	KCT0003282
Unique Protocol ID	KUH1280113
Public/Brief Title	A human study to evaluate the efficacy and safety of rice bran extract on climacteric symptoms in perimenopausal and postmenopausal women
Scientific Title	A human study to evaluate the efficacy and safety of rice bran extract on climacteric symptoms in perimenopausal and postmenopausal women
Acronym
MFDS Regulated Study	No
IND/IDE Protocol	No
Registered at Other Registry	No
Healthcare Benefit Approval Status	Not applicable

2. Institutional Review Board / Ethics Committee

Institutional Review Board Information
Board Approval Status	Submitted approval
Board Approval Number	KUH1280113
Approval Date	2018-04-26
Institutional Review Board Name	KONKUK UNIVERSITIY MEDICAL CENTER IRB
Institutional Review Board Address	120-1, Neungdong-ro, Gwangjin-gu, Seoul
Institutional Review Board Telephone	02-2030-6522
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	Tae-Eun Kim
Title	Assistant Professor
Telephone	+82-2-2030-7685
Affiliation	Konkuk University Medical Center
Address	120-1 Neungdong-ro, Gwangin-gu, Seoul
Contact Person for Public Queries
Name	Tae-Eun Kim
Title	Assistant Professor
Telephone	+82-2-2030-7685
Affiliation	Konkuk University Medical Center
Address	120-1 Neungdong-ro, Gwangin-gu, Seoul
Contact Person for Updating Information
Name	Min Young Um
Title	Senior researcher
Telephone	+82-63-219-9409
Affiliation	Korea Food Research Institute
Address	245, Nongsaengmyeong-ro, Iseo-myeon, Wanju-gun, Jeollabuk-do 55365

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	2018-07-03 Actual
Target Number of Participant	60
Primary Completion Date
Study Completion Date
Name of Study	Konkuk University Medical Center
Recruitment Status	Recruiting
Date of First Enrollment	2018-07-03 ,

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	Ministry of Agriculture, Food and Rural Affairs
Organization Type	Government
Project ID	116036-03

6. Sponsor Organization

Sponsor Organization Information - Organization Name, Organization Type
1. Sponsor Organization
Organization Name	S&D
Organization Type	Others

7. Study Summary

Study Summary Information
Lay Summary	We investigated the efficacy and safety of rice bran extracts on the climacteric symptoms in postmenopausal and postmenopausal women with moderate to severe menopausal symptoms.

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, Caregiver, Outcome Accessor
Allocation	RCT
Intervention Type	Dietary Supplement
Intervention Description	Subjects will be randomly allocated to placebo or rice bran extract group and consume the assigned investigator food once a day, 3 capsules for 12 weeks.
Number of Arms	2
Arm 1	Arm Label Rice bran extract group
	Target Number of Participant 30
	Arm Type Experimental
	Arm Description Rice bran extract 1,000 mg/day (once a day, 3 capsules) for 12 weeks
Arm 2	Arm Label Placebo
	Target Number of Participant 30
	Arm Type Placebo comparator
	Arm Description placebo 1,000 mg/day (once a day, 3 capsules) for 12 weeks Daily intake and ingestion method: In the same way as the test food

9. Subject Eligibility

Subject Eligibility Information
Condition(s)/Problem(s)	* (N00-N99)Diseases of the genitourinary system (N95.1)Menopausal and female climacteric states * Reproductive and Urinary Physiological Phenomena - Menopause
Rare Disease	No
Inclusion Criteria	Gender Female
	Age 45Year~65Year
	Description 1) Subject who agrees to participate in the study and signs the informed consent form 2) Women aged 45–65 years 3) Post-menopausal (amenorrhea ≥ 12 months) or peri-menopausal (amenorrhea ≥ 3 month & follicle stimulating hormone (FSH) > 30 IU/L) 4) Moderate or severe menopausal symptoms (score ≥ 15), identified by the Kupperman index
Exclusion Criteria	1) Subjects with surgical or chemotherapy induced menopause, Subjects who have been vaginal bleeding without diagnosis 2) Hormone therapy within the past 6 months prior to the first visit 3) Subjects who consumed the functional food or oriental medicine that can affect menopausal health, blood glucose, blood lipids (triglycerides, cholesterol, etc.), blood pressure, blood circulation within 4 weeks prior to the first visit 4) Use of medication within the past 4 weeks: sleep-inducing agents, antidepressants, selective estrogen receptor modulators, antihyperlipidemic drugs, antihypertensive drugs, beta-blockers, antidiabetic drugs. However, in the case of beta-blockers, they may be included in the subject if they are expected to have no change of taking dose for one year or have no change of taking dose during the study. 5) History of breast cancer, endometrial hyperplasia, uterine endometrial cancer, and sex steroid dependent organ tumors or subjects with clinically significant abnormality in thyroid function test, mammography, or pelvic ultrasound 6) Abnormality in renal and liver function (eGFR < 60; ALT or AST > the upper limit of normal levels x 2.5), uncontrolled hypertension (systolic blood pressure (SBP)/diastolic blood pressure (DBP) >160/100 mmHg), thyroid disease, diabetes mellitus, hyperlipidemia 7) History of severe migraine headache, thromboembolic disorders, cerebrovascular disorders, serious cardiovascular conditions within 1 year 8) Beck Depression Inventory score ≤13, ≥ 29 9) History of drug abuse, or alcoholism 10) Subjects who performed continuous high-intensity exercises at least 3 months prior to the first visit (≥10 hours/week) 11) Allergy (hypersensitivity) to any of the materials used in the study 12) Subject who participated in other clinical trial within 1 month 13) Other cases considered inappropriate for the clinical trial by the investigator
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	Kupperman index
Timepoint	0, 6, and 12 week
Secondary Outcome(s) 1
Outcome	Climacteric symptoms questionnaire
Timepoint	0, 6, and 12 weeks
Secondary Outcome(s) 2
Outcome	Markers of lipid metabolism
Timepoint	0, 6, and 12 weeks
Secondary Outcome(s) 3
Outcome	Anthropometric markers
Timepoint	0, 6, and 12 weeks
Secondary Outcome(s) 4
Outcome	Safety markers
Timepoint	0, 12 weeks

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	No

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	No

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