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WS®1442 in Slightly Overweight Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00982501
Recruitment Status : Completed
First Posted : September 23, 2009
Last Update Posted : May 14, 2014
Sponsor:
Information provided by:
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

Condition or disease Intervention/treatment Phase
Overweight 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 Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Official Title: Investigation of Safety of WS®1442 in Slightly Overweight Subjects With Pilot Assessment of Pharmacodynamic Effects of WS®1442 on Endothelial Function
Study Start Date : June 2008
Actual Primary Completion Date : September 2010
Actual Study Completion Date : February 2011

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



Primary Outcome Measures :
  1. Adverse events [ Time Frame: 12 weeks ]
  2. Lab parameters [ Time Frame: 12 weeks ]
  3. Vital signs [ Time Frame: 12 weeks ]
  4. Treadmill test including lactate measurement [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Endothelial function [ Time Frame: 12 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00982501


Locations
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Austria
University Institute of Sports Medicine, Prevention and Rehabilitation, Paracelsus Medical University Salzburg
Salzburg, Austria, 5020
Sponsors and Collaborators
Dr. Willmar Schwabe GmbH & Co. KG
Investigators
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Principal Investigator: Josef Niebauer, M.D., Ph.D. University Institute of Sports Medicine, Prevention and Rehabilitation
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Responsible Party: Professor Josef Niebauer, M.D., Ph.D., Universitaetsinstitut fuer praeventive und rehabilitative Sportmedizin der Paracelsus Medizinischen Privatuniversitaet, Institut fuer Sportmedizin des Landes Salzburg, Lindhofstr. 20, 5020 Salzburg, Austria
ClinicalTrials.gov Identifier: NCT00982501    
Other Study ID Numbers: 501004.01.103
First Posted: September 23, 2009    Key Record Dates
Last Update Posted: May 14, 2014
Last Verified: May 2014
Keywords provided by Dr. Willmar Schwabe GmbH & Co. KG:
(BMI 25-29,9 kg/m2)
Additional relevant MeSH terms:
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Overweight
Body Weight
Signs and Symptoms