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

Phase 3

Terminated

• Conditions: Coronary Disease; Metabolic Syndrome X; Bone Diseases
• Interventions: Behavioral: wellness control, placebo; Behavioral: exercise; Behavioral: exercise + cimicifuga racemosa

• Registration Number: NCT00663104
• Lead Sponsor: University of Erlangen-Nürnberg Medical School

Brief 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2008-04
• Study First Submitted: 2008-04-21
• Study First Submitted QC: 2008-04-21
• Study First Posted: 2008-04-22
• Primary Completion: 2009-06
• Study Completion: 2009-11
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-27
• Last Update Posted: 2015-05-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 126

Inclusion Criteria

• 1-3 years early postmenopausal
• Caucasian race

Exclusion Criteria

• CHD-diseases
• thrombosis, embolism
• fractures at lumbar spine or hip
• secondary osteoporosis
• hyperparathyroidism
• medication, diseases with impact on muscle or bone
• cancer and hormone derived malign diseases
• weight reduction of > 5 kg during the last 6 months

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3	wellness control, placebo	wellness control, placebo
1	exercise	exercise (3 sessions/week)
2	exercise + cimicifuga racemosa	exercise and "phytoestrogen" (cimicifuga racemosa)

Primary Outcome Measures

Name	Time	Method
Bone Mineral Density	baseline, 12 month

Secondary Outcome Measures

Name	Time	Method
body composition	baseline, 12 month
blood lipids, glucose	baseline, 12 month
blood pressure	baseline, 12 month
10 year CHD-risk	baseline, 12 months
menopausal complaints	baseline, 12 months

Trial Locations

Locations (1)

Institute of Medical Physics; 🇩🇪 Erlangen, Germany