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Completed

NCT Number: NCT00982501

WS®1442 in Slightly Overweight Subjects

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

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Key information

Conditions

Overweight Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

45 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

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

Salzburg, 5020, Austria

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

WS® 1442 900 mg/d

Drug

WS® 1442 1800 mg/d

Drug

Nordic walking training 2 x 30 min/week

Behavioral

Nordic walking training 4x45 min/week

Behavioral

Primary outcomes

  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 outcomes

  1. Endothelial function

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

Dr. Willmar Schwabe GmbH & Co. KG

Industry

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2010
Study completion
2011
First posted
Sep 23, 2009
Registry last updated
May 14, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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