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Effect of Exercise and Phytoestrogen on Bone, Metabolic Syndrome Criteria and Complaints of the Early Menopause

NCT00663104 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 126

Last updated 2015-05-28

No results posted yet for this study

Summary

The aim of the study is to compare the effect of a progressive, periodized exercise training designed to impact bone, CHD-risk-factors and menopausal complaints versus the combined effect of exercise and "phytoestrogen" (cimicifuga racemosa; CR). After randomization, 84 females 1-3 year postmenopausal with no medication or illness affecting bone metabolism exercise over 12 months (EG; 42 with, 42 without CR), 42 women serve as wellness-control. Three group training sessions/week will be performed in the EG. Both groups will be individually supplemented with calcium and Vit-D (cholecalciferol).

Conditions

  • Bone Diseases
  • Metabolic Syndrome X
  • Coronary Disease

Interventions

BEHAVIORAL

exercise

exercise: 3 joint sessions/week for 12 months

BEHAVIORAL

exercise + cimicifuga racemosa

exercise: 3 sessions/week for 12 months,cimicifuga racemosa (40 mg/d)

BEHAVIORAL

wellness control, placebo

2x10 weeks with 1 session/week of low volume, low intensity wellness training over 12 months, placebo

Sponsors & Collaborators

  • Siemens-Betriebskrankenkasse

    collaborator INDUSTRY

  • University of Erlangen-Nürnberg Medical School

    lead OTHER

Principal Investigators

  • Michael Bebenek, MS · University of Erlangen-Nürnberg Medical School

  • Wolfgang Kemmler, PhD · University of Erlangen-Nürnberg Medical School

  • Willi A Kalender, Professor, PhD · University of Erlangen-Nürnberg Medical School

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Max Age
55 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-04-30
Primary Completion
2009-06-30
Completion
2009-11-30

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00663104 on ClinicalTrials.gov