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Effect of Genistein in Women With Metabolic Syndrome

NCT00541710 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2012-09-14

No results posted yet for this study

Summary

The purpose of this study is to determine whether the phytoestrogen genistein is effective in improving bone condition in pre-menopausal and post-menopausal women suffering for osteopenia. Since, during the study the investigators realized that at least 70% of post-menopausal recruited women suffered for metabolic syndrome (MS), we have added only in these women, as secondary outcome measures, the evaluation of markers of cardiovascular risk.

Conditions

  • Metabolic Syndrome

Interventions

DIETARY_SUPPLEMENT

genistein

pills of 27 mg, twice per day for 12 months

DIETARY_SUPPLEMENT

placebo

sugar pills twice per day for 12 months

Sponsors & Collaborators

  • Ministry of Education, Universities and Research, Italy

    collaborator OTHER

  • University of Messina

    lead OTHER

Principal Investigators

  • Rosario D'Anna, professor · University of Messina, Italy

  • Francesco Squadrito, MD · University of Messina

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-10-31
Primary Completion
2011-01-31
Completion
2011-09-30

Countries

  • Italy

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 NCT00541710 on ClinicalTrials.gov