WS®1442 in Slightly Overweight Subjects

• Status: Completed
• Trial end date: 2011-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to test:

1. Safety of 900 mg or 1800 mg of WS® 1442 per day in overweight subjects (BMI 25 to 29,9 kg/m²)

2. Pharmacodynamic effect of WS® 1442 on endothelial function versus nordic walking training in overweight subjects

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Dr. Willmar Schwabe GmbH & Co. KG

Criteria

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