WS®1442 in Slightly Overweight Subjects

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00982501

Enrollment

Registered

2009-09-23

Start date

2008-06-30

Completion date

2011-02-28

Last updated

2014-05-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Overweight

Keywords

(BMI 25-29,9 kg/m2)

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.

Interventions

DRUGWS® 1442 900 mg/d

DRUGWS® 1442 1800 mg/d

BEHAVIORALNordic walking training 2 x 30 min/week

BEHAVIORALNordic walking training 4x45 min/week

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

45 Years to 75 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Adverse events	12 weeks
Lab parameters	12 weeks
Vital signs	12 weeks
Treadmill test including lactate measurement	12 weeks

Secondary

Measure	Time frame
Endothelial function	12 weeks

Countries

Austria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026