Effects of Fermented Red Clover on Muscle Strength and Muscle Mass

November 3, 2020 updated by: University of Aarhus

Effects of Fermented Red Clover on Muscle Strength and Muscle Protein Signaling in Postmenopausal Women

The project is designed as a randomized controlled, double-blinded, cross-over trial, including 10 healthy postmenopausal women consuming fermented red clover extract or placebo twice daily over a two-week period. After the first trial (two weeks), participants will undergo a two-week washout period, after which they will receive the opposite trial drink for two weeks. The trial period runs over six weeks. Before each of the two trial rounds, participants will meet in the laboratory and perform muscle strength tests (trial days 1 and 3). After each trial round (trial days 2 and 4), participants will meet fasting in the laboratory, and a blood test and a muscle biopsy will be taken initially. Next, the subject consumes the test drink (placebo or red clover extract) before the subject performs a strength training session with one leg. Right after the training session, the subject consumes a protein drink. Three hours after the protein drink, another muscle biopsy is taken. During the period from the protein drink to the final biopsy, the subject performs two muscle strength tests (respectively grip strength and maximum upper arm muscle strength (biceps)). The primary target parameter is muscle protein signaling measured in the muscle tissue samples using the western blotting method.

Study Overview

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Aarhus, Denmark, 8000
        • Aarhus University, Department for Public Health, Section for Sport Science

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • maximum of 5 years since last menstrual bleeding
  • Minimum of 6 months since last menstrual bleeding

Exclusion Criteria:

  • Performed systematic resistance training within the last 6 months
  • Smoker
  • Using any form of medicine influencing the effects of resistance training

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
2 weeks of Placebo
Experimental: Red clover
2 weeks of Red clover

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Muscle protein signalling measured by western blotting
Time Frame: Change from pre to 3 hours post training
Change in protein content between two time points
Change from pre to 3 hours post training

Secondary Outcome Measures

Outcome Measure
Time Frame
Forearm and biceps strength measured by maximal isometric muscle strength
Time Frame: Change from Pre to post intervention.
Change from Pre to post intervention.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2019

Primary Completion (Actual)

December 17, 2019

Study Completion (Actual)

November 1, 2020

Study Registration Dates

First Submitted

October 31, 2019

First Submitted That Met QC Criteria

November 4, 2019

First Posted (Actual)

November 6, 2019

Study Record Updates

Last Update Posted (Actual)

November 4, 2020

Last Update Submitted That Met QC Criteria

November 3, 2020

Last Verified

October 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • Estrogen_2019

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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