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Phytoestrogen Supplementation in Postmenopausal Women

NCT01497977 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 74

Last updated 2011-12-29

No results posted yet for this study

Summary

The goal of the study was to assess the impact of soy and red clover derived phytoestrogens on serum lipids in postmenopausal women. Both soya and red clover have high phytoestrogen content. Phytoestrogens, a class of estrogenic molecules produced by plants bind to the estrogen receptor and are capable of producing estrogenic effects. Therefore, our hypothesis was that they can reduce the levels of serum lipids.

Materials and Methods: Researchers investigated total cholesterol, cholesterol fractions and triglycerides in blood, before treatment and in six months periods, throughout 18 months. The study involved 74 healthy postmenopausal women, divided into three groups. The first group of 23 patients received red clover derived isoflavones, the second one with 26 patients got soy derived phytoestrogens, while the third, control group with 25 patients, was without medications.

Conditions

  • Low Serum Lipid Levels

Interventions

DRUG

phytoestrogens

The red clover capsule consisted of 4 isoflavones: biokain A (23mg), daidzein (1mg), formononetin (15mg) and genistein (1mg).

DRUG

phytoestrogens

The soya daily dose contained 2 isoflavones: genistein (39mg) and daidzein (1mg).

Sponsors & Collaborators

  • American Medical Academy, Serbia

    lead OTHER

Principal Investigators

  • Tihomir Mihailovic, MD.PhD · Ultramedica Clinic, American Medical Academy

  • Milan Terzic, Prof. dr · School of Medicine, University of Belgrade

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-09-30
Primary Completion
2010-06-30
Completion
2010-06-30

Countries

  • Serbia

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 NCT01497977 on ClinicalTrials.gov