Metabolic Syndrome
Conditions
Interventions
Oral ingestion of the test product (12 weeks)
Oral ingestion of the control product (12 weeks)
Sponsors
TES Holdings Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Criteria A [1]Japanese males and females aged 30-60 years [2]Individuals whose BMI is over 25.0 kg/m^2 [3]Individuals whose weight is over 95 kg [4]Individuals who are healthy and are not poor feeding Criteria B [1]Individuals judged appropriate for the study by the principal [2]Individuals whose BMI is over 25.0 kg/m~2 (except weight shall be under 95 kg) [3]Individuals judged not decreased appetite or poor feeding by the principal investigator at the screening
Exclusion criteria
Exclusion criteria: [1]Individuals using medical products [2]Individuals who had a habit to ingest health-promoting foods, foods for specified health uses, health foods, or supplyments (ex. supplement derived from mushroom, diet supplement) in the past 1 month or will ingest those foods during the test period [3]Individuals who are or are posslibly, or are lactating [4]Individuals who excessively take alcohol [5]Individuals who have symptoms of allergy to the test product [6]Individuals who participate in other clinical studies [7]Individuals who have a history of serious hepatopathy, kidney damage, heart disease and hematological disease [8]Individuals who have a history of hepatitis [9]Individuals with serious anemia [10]Individuals who had been administrated contrast material (ex. barium) in the past 2 months or will be administrated during the test period
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| CT scanning (visceral fat) | — |
Secondary
| Measure | Time frame |
|---|---|
| Body structure Blood pressure Pulsation Hematologic test Physical measurement Subject's diary Doctor's questions Urine analysis Diet survey and management | — |
Countries
Japan
Contacts
Public ContactTES Holdings Co., Ltd.
TES Holdings Co., Ltd. Department of Clinical Trial
Outcome results
None listed