WS®1442 in Slightly Overweight Subjects

Study Overview
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Brief Summary
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The purpose of this study is to test: Safety of 900 mg or 1800 mg of WS® 1442 per day in overweight subjects (BMI 25 to 29,9 kg/m²) Pharmacodynamic effect of WS® 1442 on endothelial function versus nordic walking training in overweight subjects

Detailed Description
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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.

Official Title
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Investigation of Safety of WS®1442 in Slightly Overweight Subjects With Pilot Assessment of Pharmacodynamic Effects of WS®1442 on Endothelial Function

Conditions
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Overweight

Intervention / Treatment
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* Drug: WS® 1442 900 mg/d
* Drug: WS® 1442 1800 mg/d
* Behavioral: Nordic walking training 2 x 30 min/week
* Behavioral: Nordic walking training 4x45 min/week


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: written informed consent male and female subjects aged 45-75 years untrained BMI between 25 and 29,9 kg/m² resting blood pressure in sitting position ≤ 140/90 mmHg inconspicuous ergometry Exclusion Criteria: pregnancy or breastfeeding any other current medication intake of other hawthorn preparation or dietary supplements with possible influence on the interpretation of study results any known diseases alcohol or drug abuse/addiction nicotine abuse any known hypersensitivity to any of the ingredients of the investigated drug inability or inadequate ability to write or speak German not-postmenopausal women: positive pregnancy test or unsafe contraception any urinary test finding requiring diagnostic assessment or treatment deformation of the 2nd to 5th finger of both hands preventing an adequate measurement of endothelial function

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: WS® 1442 900 mg<br> | Drug: WS® 1442 900 mg/d<br> <br> |
| Experimental: WS® 1442 1800 mg<br> | Drug: WS® 1442 1800 mg/d<br> <br> |
| Active Comparator: Nordic walking training 2x30 min<br> | Behavioral: Nordic walking training 2 x 30 min/week<br> <br> |
| Active Comparator: Nordic walking training 4x45 min<br> | Behavioral: Nordic walking training 4x45 min/week<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events |  | 12 weeks | 
| Lab parameters |  | 12 weeks | 
| Vital signs |  | 12 weeks | 
| Treadmill test including lactate measurement |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endothelial function |  | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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(BMI 25-29,9 kg/m2)