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

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00663104

Enrollment

126

Registered

2008-04-22

Start date

2008-04-30

Completion date

2009-11-30

Last updated

2015-05-28

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

Conditions

Bone Diseases, Coronary Disease, Metabolic Syndrome X

Keywords

early menopause, exercise, phytoestrogen, bone, CHD-risk factors

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).

Interventions

BEHAVIORALexercise

exercise: 3 joint sessions/week for 12 months

BEHAVIORALexercise + cimicifuga racemosa

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

BEHAVIORALwellness control, placebo

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

45 Years to 55 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Bone Mineral Density	baseline, 12 month

Secondary

Measure	Time frame
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

Countries

Germany

Outcome results

None listed

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