Study on the usefulness of rice proteins in Japanese obese patients
Not Applicable
- Conditions
- Obesity
- Registration Number
- JPRN-UMIN000008923
- Lead Sponsor
- Department of Applied Molecular Medicine, Niigata University Graduate School of Medical and Dental Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
Not provided
Exclusion Criteria
Those who meet any of the following criteria will be excluded from the study: 1) Those who are under treatment for diabetes mellitus or hypertension 2) Those with severe heart, renal or liver disease 3) Those at perioperative stages, or those with severe infection or serious injury 4) Those with food allergy 5) Those who are considered not eligible for the study by attending doctors due to any medical reasons
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Changes in markers of lipid metabolism 4 and 8 weeks after the beginning
- Secondary Outcome Measures
Name Time Method Changes in the following parameters during the observation period: •Liver and renal function (urinary albumin/creatinine, eGFR etc) •Blood pressure •Body weight, body mass index and waist circumference Evaluation of the safety during the study period; Frequency of adverse events Adverse events are analyzed with Common Terminology Criteria for Adverse Events v4.0-JCOG when they happen. Exploratory analysis; Inflammation concerned with nutritional status is evaluated by the analysis of oxidative stress markers including 8-OHdG. Novel biomakers including urinary megalin are measured and analyzed for the association with other markers.