WS®1442 in Slightly Overweight Subjects

Phase 1

Completed

• Conditions: Overweight
• Interventions: Behavioral: Nordic walking training 2 x 30 min/week; Behavioral: Nordic walking training 4x45 min/week; Drug: WS® 1442 900 mg/d; Drug: WS® 1442 1800 mg/d

• Registration Number: NCT00982501
• Lead Sponsor: Dr. Willmar Schwabe GmbH & Co. KG

Brief 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

Detailed Description

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 Timeline

• Study Start: 2008-06
• Study First Submitted: 2009-09-22
• Study First Submitted QC: 2009-09-22
• Study First Posted: 2009-09-23
• Primary Completion: 2010-09
• Study Completion: 2011-02
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-13
• Last Update Posted: 2014-05-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nordic walking training 2x30 min	Nordic walking training 2 x 30 min/week	-
Nordic walking training 4x45 min	Nordic walking training 4x45 min/week	-
WS® 1442 900 mg	WS® 1442 900 mg/d	-
WS® 1442 1800 mg	WS® 1442 1800 mg/d	-

Primary Outcome Measures

Name	Time	Method
Adverse events	12 weeks
Lab parameters	12 weeks
Vital signs	12 weeks
Treadmill test including lactate measurement	12 weeks

Secondary Outcome Measures

Name	Time	Method
Endothelial function	12 weeks

Trial Locations

Locations (1)

University Institute of Sports Medicine, Prevention and Rehabilitation, Paracelsus Medical University Salzburg; 🇦🇹 Salzburg, Austria