Weight-control Effect of Rice-based Diet

• Register: KCT
• Last refreshed on: 27 April 2013
• Main ID: KCT0000315
• Date of registration: 09/01/2012
• Primary sponsor: Korea Institute Planing and Evaluation for Technology of Food, Agriculture, Forestry and Fisheries
• Public title: Weight-control Effect of Rice-based Diet
• Scientific title: Weight-control Effect of Rice-based Diet
• Date of first enrolment: 2012-01-13
• Target sample size: 800
• Recruitment status: Not yet recruiting
• URL: http://cris.nih.go.kr/cris/en/search/search_result_st01.jsp?seq=1720
• Study type: Interventional Study
• Study design: Primary Purpose : Supportive Care, Intervention Model : Parallel, Blinding/Masking : Open, Allocation : RCT

Countries of recruitment

Korea, Republic of

Contacts

• Name: Jae Kang
• Affiliation: Inje University Seoul Paik Hospital

• Name: Yang Hur
• Affiliation: Inje University Seoul Paik Hospital

Key inclusion & exclusion criteria

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


Age minimum: 20(Year)
Age maximum: 60(Year)
Gender: Both

Health Condition(s) or Problem(s) studied

Endocrine, nutritional and metabolic disease

Intervention(s)

Behavioral : Both groups will be provided low-calory, low-fat and low-sodium diet education and nutrition education materials at 0 week and 12week.
Additionally, rice-based diet group will be educated to eat rice-based diet(rice which mix white-rice and brown-rice at a ratio of 80:20) three times a day.

Primary Outcome(s)

blood pressure

fasting glucose

HDL-cholesterol

triglyceride

waist circumference

weight

Secondary Outcome(s)

body mass index

calory of each diet

fat maas, free fat mass

highly sensitive C-reactive protein(hsCRP)

hip circumference

insulin

LDL-cholesterol

Nutrients of each diet

total-cholesterol

Secondary Sponsor(s)

Inju University Seoul Paik Hospitial Institute for Clinical Nutrition