Clinical trial of black rice to evaluate efficacy on bone health and obesity
- Conditions
- Endocrine, nutritional and metabolic disease
- Registration Number
- KCT0005836
- Lead Sponsor
- Eulji University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 84
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
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
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change of body fat amount and body fat % measured by dual-energy x-ray absorptiometry(DEXA);Change of body fat amount and body fat % measured by computed tomography(CT);Weight, body mass index(BMI), mid-arm circumference(MAC), waist circumference, hip circumference, thigh circumference, waist hip ratio;Change of body fat % measured by bioelectrical impedance analysis (BIA);Total Cholesterol, triglyceride, HDL-Cholesterol, LDL-Cholesterol;Change of bone mineral density (BMD) measured by dual-energy x-ray absorptiometry(DEXA);Urinary type I collagen telopeptide (NTx,CTx);Serum osteocalcin, calcium, ALP, BAP
- Secondary Outcome Measures
Name Time Method Kupperman Index;Laboratory measurements;Adverse Event;Vital Signs