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OpenTrials
Completed

NCT Number: NCT04154306

Effects of Fermented Red Clover on Muscle Strength and Muscle Mass

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.

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Key information

Conditions

Age range

40 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Aarhus University, Department for Public Health, Section for Sport Science

Aarhus, 8000, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

red clover

Dietary Supplement

2 weeks of Red clover

Placebo

Dietary Supplement

2 weeks of Placebo

Primary outcomes

  1. 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

Secondary outcomes

  1. Forearm and biceps strength measured by maximal isometric muscle strength

    Time frame: Change from Pre to post intervention.

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
Nov 6, 2019
Registry last updated
Nov 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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