WS®1442 in Slightly Overweight Subjects

Dr. Willmar Schwabe GmbH & Co. KG60 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

DOUBLE

Enrollment

Conditions

Overweight

Interventions

WS® 1442 900 mg/dDRUG

WS® 1442 1800 mg/dDRUG

Nordic walking training 2 x 30 min/weekBEHAVIORAL

Nordic walking training 4x45 min/week

Eligibility

Sex: ALLMin age: 45 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

University Institute of Sports Medicine, Prevention and Rehabilitation, Paracelsus Medical University Salzburg

Salzburg, Austria

Outcomes

Primary Outcomes

Adverse events

Time frame: 12 weeks

Lab parameters

Time frame: 12 weeks

Vital signs

Time frame: 12 weeks

Treadmill test including lactate measurement

Time frame: 12 weeks

Secondary Outcomes

Endothelial function

Time frame: 12 weeks

Data from ClinicalTrials.gov

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