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Isoflavone Treatment for Postmenopausal Osteopenia.

NCT02174666 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 85

Last updated 2023-12-04

No results posted yet for this study

Summary

The aim of the project is to execute a double-blind, parallel, randomized 12-month intervention trial on postmenopausal women with osteopenia (low bone mineral density), in order to determine the effects of daily intake of fermented red clover (RC) extract on estrogen dependent bone mineral resorption when compared to placebo. Both groups will recieve equivalent daily calcium, vitamin D and magnesium supplements. The project will also assess whether bioactive compounds in RC can reduce the risk of developing cardiovascular disease.

Conditions

Interventions

DIETARY_SUPPLEMENT

Red clover extract

Aglycone isoflavones 80mg/d

DIETARY_SUPPLEMENT

Supplementation (placebo)

Sponsors & Collaborators

  • European Regional Development Fund

    collaborator OTHER

  • The Ministry of Science, Technology and Innovation, Denmark

    collaborator OTHER_GOV

  • University of Aarhus

    lead OTHER

Principal Investigators

  • Per B Jeppesen, Prof PhD · Department of Medicine and Endocrinology MEA, Aarhus University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
85 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-06-30
Primary Completion
2016-10-31
Completion
2016-11-30

Countries

  • Denmark

Study Locations

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Entities

Diseases

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 NCT02174666 on ClinicalTrials.gov