Clinical trial of black rice to evaluate efficacy on bone health and obesity

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0005836

Enrollment

Registered

2021-01-28

Start date

2014-11-11

Completion date

Unknown

Last updated

2021-02-23

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 : - 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

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 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

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

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

Measure	Time frame
Kupperman Index;Laboratory measurements;Adverse Event;Vital Signs	—

Countries

Korea, Republic of

Contacts

Public ContactAh Jin Jung

Gachon University

Outcome results