WS®1442 in Slightly Overweight Subjects

May 13, 2014 updated by: Dr. Willmar Schwabe GmbH & Co. KG

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Salzburg, Austria, 5020
        • University Institute of Sports Medicine, Prevention and Rehabilitation, Paracelsus Medical University Salzburg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Endothelial function
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dr. Willmar Schwabe GmbH & Co. KG

Investigators

  • Principal Investigator: Josef Niebauer, M.D., Ph.D., University Institute of Sports Medicine, Prevention and Rehabilitation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2008

Primary Completion (Actual)

September 1, 2010

Study Completion (Actual)

February 1, 2011

Study Registration Dates

First Submitted

September 22, 2009

First Submitted That Met QC Criteria

September 22, 2009

First Posted (Estimate)

September 23, 2009

Study Record Updates

Last Update Posted (Estimate)

May 14, 2014

Last Update Submitted That Met QC Criteria

May 13, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 501004.01.103

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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