Status Approved
First Submitted Date
2021/01/21
Registered Date
2021/01/28
Last Updated Date
2021/01/21
CRIS Required
WHO ICTRP (International Clinical Trial Registry Platform) Required
1. Background
CRIS Registration Number |
KCT0005836 |
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Unique Protocol ID | EU 14-07 |
Public/Brief Title | Clinical trial of black rice to evaluate efficacy on bone health and obesity |
Scientific Title | Clinical trial of black rice to evaluate efficacy on bone health and obesity |
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
Board Approval Status | Submitted approval |
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Board Approval Number | EU 14-07 |
Approval Date | 2014-09-22 |
Institutional Review Board Name | Institutional Review Board of Eulji University |
Institutional Review Board Address | 77, Gyeryong-ro 771beon-gil, Jung-gu, Daejeon |
Institutional Review Board Telephone | 042-259-1691 |
Data Monitoring Committee | No |
3. Contact Details
Contact Person for Principal Investigator / Scientific Queries | |
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Name | Hae-Jeung Lee |
Title | Professor |
Telephone | +82-31-750-4720 |
Affiliation | Gachon University |
Address | 1342, Seongnam-daero, Sujeong-gu, Seongnam-si, Gyeonggi-do, Republic of Korea |
Contact Person for Public Queries | |
Name | Ah Jin Jung |
Title | Researcher |
Telephone | +82-31-750-4720 |
Affiliation | Gachon University |
Address | 1342, Seongnam-daero, Sujeong-gu, Seongnam-si, Gyeonggi-do, Republic of Korea |
Contact Person for Updating Information | |
Name | Ah Jin Jung |
Title | Researcher |
Telephone | +82-31-750-4720 |
Affiliation | Gachon University |
Address | 1342, Seongnam-daero, Sujeong-gu, Seongnam-si, Gyeonggi-do, Republic of Korea |
4. Status
Study Site | Single | |
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Overall Recruitment Status | Completed | |
Date of First Enrollment | 2014-11-11 Actual | |
Target Number of Participant | 84 | |
Primary Completion Date | ||
Study Completion Date | ||
Recruitment Status by Participating Study Site 1 | ||
Name of Study | Eulji University Medical Center | |
Recruitment Status | Completed | |
Date of First Enrollment | 2014-11-11 , |
5. Source of Monetary / Material Support
1. Source of Monetary/Material Support | |
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Organization Name | Rural Development Administration |
Organization Type | Government |
Project ID |
6. Sponsor Organization
1. Sponsor Organization | |
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Organization Name | Eulji University |
Organization Type | University |
7. Study Summary
Lay Summary | The menopause is associated with an increase in women's health risks and abdominal fat distribution. It was reported that postmenopausal women had a 4.88-fold higher risk of developing abdominal obesity than premenopausal subjects. Prevention of weight gain from menopause is important to have a quality of healthy life for older women. Black rice is a type of colored rice that contains abundant anthocyanins in its outer layer. Anthocyanins found in black rice are known to have various health benefits. In animal model showed that supplementation of black rice aleurone layer extract decreased fat mass and body weight and also prevented the reduction in bone strength and density. Therefore, The purpose of this study is to evaluate the effects of black rice extract supplement on body fat reduction and bone density in postmenopausal obese women aged 45-69 years old. |
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8. Study Design
Study Type | Interventional Study |
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Study Purpose | Prevention |
Phase | Not applicable |
Intervention Model | Parallel |
Blinding/Masking | Double |
Blinded Subject | Subject, Investigator |
Allocation | RCT |
Intervention Type | Dietary Supplement |
Intervention Description | - Study Supplement : black rice extract(1g/day), Placebo : maltodextrin(1g/day) During 12 weeks, take one capsule twice daily(2 capsules/d total) after breakfast and dinner |
Number of Arms | 2 |
Arm 1 |
Arm Label Black rice extract(BRE) group |
Target Number of Participant 50 |
|
Arm Type Experimental |
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Arm Description During 12 weeks, black rice extract(1g/day) take one capsule twice daily(2 capsules/d total) after breakfast and dinner |
|
Arm 2 |
Arm Label Placebo group |
Target Number of Participant 50 |
|
Arm Type Placebo comparator |
|
Arm Description During 12 weeks, maltodextrin(1g/day) take one capsule twice daily(2 capsules/d total) after breakfast and dinner |
9. Subject Eligibility
Condition(s)/Problem(s) |
* (E00-E90)Endocrine, nutritional and metabolic diseases (E66.9)Obesity, unspecified Obesity |
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Rare Disease | No |
Inclusion Criteria |
Gender Female |
Age 45Year~69Year |
|
Description 1) Postmenopausal women aged 45 to 69 y for 12 months without a menstrual period 2) BMI (in kg/m2) ≧ 25.0 3) Subjects who had never taken estrogen or drugs related to bone health or obesity in the last year 4) Subjects who gave written informed consent |
|
Exclusion Criteria |
1) History of thyroid disease, diabetes, kidney disease or ovarian cancer that affect bone metabolism 2) Current use of hormone replacement therapy 3) Use of weight loss medication (absorption inhibitors, antidepressants, appetite suppressants, contraceptives, steroids, female hormones) 4) Having participated in an obesity prevention programs or taken weight loss supplements within the last 3 months 5) Fasting blood glucose ≧ 126 mg/dl or blood glucose ≧ 200 mg/dl, or diabetic patients taking oral hypoglycemic agents or insulin 6) History of heart, kidney, thyroid or cerebrovascular disease 7) History of gallbladder disease, gastrointestinal disease, gout, or porphyria 8) History of mental disorder such as schizophrenia, alcohol or drug abuse 9) Hypersensitive reaction to any of the ingredients in the study supplements 10) Unable to communicate or blind or hearing loss 11) Unable to exercise from severe musculoskeletal disease 12) History of cancer diagnosis or treatment within the last 5 years 13) History of asthma or other allergic diseases 14) History of surgery within the last 1 year 15) Having participation in other clinical trials within the last 3 months 16) Unable to read letters 17) Any other reasons unsuitable for the trial assessed by the investigator |
Healthy Volunteers | Yes |
10. Outcome Measure(s)
Type of Primary Outcome | /Safety/Efficacy | |
---|---|---|
Primary Outcome(s) 1 | ||
Outcome | Change of body fat amount and body fat % measured by dual-energy x-ray absorptiometry(DEXA) |
|
Timepoint | Visit 2, Visit 5, Visit 8(Participants who agreed to extend research) |
|
Primary Outcome(s) 2 | ||
Outcome | Change of body fat amount and body fat % measured by computed tomography(CT) |
|
Timepoint | Visit 2, Visit 5 |
|
Primary Outcome(s) 3 | ||
Outcome | Weight, body mass index(BMI), mid-arm circumference(MAC), waist circumference, hip circumference, thigh circumference, waist hip ratio |
|
Timepoint | Visit 1, Visit 3, Visit 4, Visit 5, Visit 6, Visit 7, Visit 8 |
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Primary Outcome(s) 4 | ||
Outcome | Change of body fat % measured by bioelectrical impedance analysis (BIA) |
|
Timepoint | Visit 1, Visit 3, Visit 4, Visit 5, Visit 6, Visit 7, Visit 8 |
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Primary Outcome(s) 5 | ||
Outcome | Total Cholesterol, triglyceride, HDL-Cholesterol, LDL-Cholesterol |
|
Timepoint | Visit 1, Visit 5 |
|
Primary Outcome(s) 6 | ||
Outcome | Change of bone mineral density (BMD) measured by dual-energy x-ray absorptiometry(DEXA) |
|
Timepoint | Visit 2, Visit 5, Visit 8(Participants who agreed to extend research) |
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Primary Outcome(s) 7 | ||
Outcome | Urinary type I collagen telopeptide (NTx,CTx) |
|
Timepoint | Visit 1, Visit 5 |
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Primary Outcome(s) 8 | ||
Outcome | Serum osteocalcin, calcium, ALP, BAP |
|
Timepoint | Visit 1, Visit 5 |
|
Secondary Outcome(s) 1 | ||
Outcome | Kupperman Index |
|
Timepoint | Visit 1, Visit 5 |
|
Secondary Outcome(s) 2 | ||
Outcome | Laboratory measurements |
|
Timepoint | Visit 1, Visit 5 |
|
Secondary Outcome(s) 3 | ||
Outcome | Adverse Event |
|
Timepoint | Visit 3, Visit 4, Visit 5, Visit 6, Visit 7, Visit 8 |
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Secondary Outcome(s) 4 | ||
Outcome | Vital Signs |
|
Timepoint | Visit 1, Visit 3, Visit 4, Visit 5, Visit 6, Visit 7, Visit 8 |
11. Study Results and Publication
Result Registered | No |
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12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
Sharing Statement | No |
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