NCT00663104

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

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

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 126 (actual)
• Sponsor: University of Erlangen-Nürnberg Medical School · Academic / Other
• Sex: Female
• Age: 45 Years – 55 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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

Timeline

• Start date: 2008-04-01
• Primary completion: 2009-06-01
• Completion: 2009-11-01
• First posted: 2008-04-22
• Last updated: 2015-05-28

Locations

1 site across 1 country: Germany