Weight-control Effect of Rice-based Diet

Not Applicable

• Conditions: Endocrine, nutritional and metabolic disease

• Registration Number: KCT0000315
• Lead Sponsor: Inje University Seoul Paik Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 11 March 2019

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 800

Inclusion Criteria

? any 3 of 5 constitute diagnosis of metabolic syndrome
1. Elevated waist circumference : =90 cm in men
=85 cm in women
2. Elevated triglycerides : =150 mg/dL (1.7 mmol/L)
or On drug treatment for elevated triglycerides
3. Reduced HDL-C : <40 mg/dL (1.03 mmol/L) in men
<50 mg/dL (1.3 mmol/L) in women
or On drug treatment for reduced HDL-C‡
4. Elevated blood pressure: =130 mm Hg systolic blood pressure or
=85 mm Hg diastolic blood pressure or
On antihypertensive drug treatment in a patient
with a history of hypertension
5. Elevated fasting glucose : =100 mg/dL
or On drug treatment for elevated glucose
? Patients who agreed to write about food diary and physical activity Questionnaire
? Patients who agreed to participate volutary in this clinical trial

Exclusion Criteria

? The patients with physical measurements are difficult due to anatomical change, such as surgical resection of part of the body
? The Patients with thyroid fuction disease (TSH is under 0.1 uU/ml, or over 10 uU/ml)
? The Patients with severe cerebrovascular disease(infarct, hemorrage), cardiac disease(angina, myocardiac infarct, heart failure, arrhythmias that require treatment) within recent 6 months. (If that patient's clinical status is stable, they can participate in the clinical trial according to investgator)
? The Patients with severe liver or kidney function abnormality
- plasma ALT or AST level is more than 3 times the upper limit of normal
- plsma creatinine level is more than 1.5 times the upper limit of normal
? The Patients with mental illness such as depression, Schizophrenia, alcoholism, drug addiction etc.
? Pregnant and lactating women, and women of childbearing age who do not agree with choose an appropriate contraceptive method or are planning to pregnant
? The patient who take the medicine that can affect the state of weight, glucose and lipid level (uptake inhibitors, antidepressant, appetite suppressant, antiobesity-related health functional food / supplements, antipsychotics, contraceptives, steroid, and hormon)within recent 3 months
? The patients who had surgical procedure for reducing weight (bariatric surgery such as gastric bypass and gastric banding)
? The patients who lose weignt over 10 percent within 3 months
? The patients who took part in other clinical trial within 3 months
? The patients who cannot excersise due to severe musculoskeletal disorders
? The patients who stopped smoking within recent 6 months or chage frequently smoking habit
? The patients who have low motivation for attending or will not following the observances of this clinical trial, depend on opinion of representative clinical trials

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
weight ;waist circumference;triglyceride ;HDL-cholesterol;fasting glucose;blood pressure

Secondary Outcome Measures

Name	Time	Method
body mass index;hip circumference;fat maas, free fat mass;total-cholesterol;insulin;highly sensitive C-reactive protein(hsCRP);calory of each diet;Nutrients of each diet;LDL-cholesterol