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The purpose of this study is to test:
60 overweight subjects with a BMI of 25 to 29,9 kg/m2 are to be included. The safety of 900 mg/1800 mg per day WS® 1442 is determined by adverse events, laboratory parameters, vital signs as well as by a treadmill test at the beginning and the end of the study. Endothelial function measured before and after two different training modalities is compared to that measured before and after intake of two different doses of WS® 1442.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| WS® 1442 900 mg | Experimental |
| |
| WS® 1442 1800 mg | Experimental |
| |
| Nordic walking training 2x30 min | Active Comparator |
| |
| Nordic walking training 4x45 min | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| WS® 1442 900 mg/d | Drug |
| ||
| WS® 1442 1800 mg/d |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | 12 weeks | |
| Lab parameters | 12 weeks | |
| Vital signs | 12 weeks | |
| Treadmill test including lactate measurement | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Endothelial function | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Josef Niebauer, M.D., Ph.D. | University Institute of Sports Medicine, Prevention and Rehabilitation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Institute of Sports Medicine, Prevention and Rehabilitation, Paracelsus Medical University Salzburg | Salzburg | 5020 | Austria |
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| ID | Term |
|---|---|
| D050177 | Overweight |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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|
| Nordic walking training 2 x 30 min/week | Behavioral |
|
| Nordic walking training 4x45 min/week | Behavioral |
|
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |