Obesity
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Those who fulfill the following criteria will be included in the study: 1) Male or female obese subjects with BMI> or = 25kg/m2 or subjects with metabolic syndrome (visceral obesity) 2) Those who have given written informed consent on the use of their data for the study
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in markers of lipid metabolism 4 and 8 weeks after the beginning | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Japan
Contacts
Niigata University Graduate School of Medical and Dental Sciences Department of Applied Molecular Medicine