WS®1442 in Slightly Overweight Subjects

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Study Completion Date

2011-02-28

Brief Summary

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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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Detailed Description

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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.

Conditions

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Overweight

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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WS® 1442 900 mg

Group Type EXPERIMENTAL

WS® 1442 900 mg/d

Intervention Type DRUG

WS® 1442 1800 mg

Group Type EXPERIMENTAL

WS® 1442 1800 mg/d

Intervention Type DRUG

Nordic walking training 2x30 min

Group Type ACTIVE_COMPARATOR

Nordic walking training 2 x 30 min/week

Intervention Type BEHAVIORAL

Nordic walking training 4x45 min

Group Type ACTIVE_COMPARATOR

Nordic walking training 4x45 min/week

Intervention Type BEHAVIORAL

Interventions

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WS® 1442 900 mg/d

Intervention Type DRUG

WS® 1442 1800 mg/d

Intervention Type DRUG

Nordic walking training 2 x 30 min/week

Intervention Type BEHAVIORAL

Nordic walking training 4x45 min/week

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

45 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Universitaetsinstitut fuer praeventive und rehabilitative Sportmedizin der Paracelsus Medizinischen Privatuniversitaet, Institut fuer Sportmedizin des Landes Salzburg, Lindhofstr. 20, 5020 Salzburg, Austria