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Effects of Fermented Red Clover on Muscle Strength and Muscle Mass

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ClinicalTrials.gov Identifier: NCT04154306
Recruitment Status : Recruiting
First Posted : November 6, 2019
Last Update Posted : November 6, 2019
Sponsor:
Information provided by (Responsible Party):
University of Aarhus

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Estrogen Deficiency Dietary Supplement: Red clover Dietary Supplement: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Other
Official Title: Effects of Fermented Red Clover on Muscle Strength and Muscle Protein Signaling in Postmenopausal Women
Estimated Study Start Date : November 1, 2019
Estimated Primary Completion Date : December 17, 2019
Estimated Study Completion Date : May 1, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Red clover

Arm Intervention/treatment
Placebo Comparator: Placebo Dietary Supplement: Placebo
2 weeks of Placebo

Experimental: Red clover Dietary Supplement: Red clover
2 weeks of Red clover




Primary Outcome Measures :
  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 Outcome Measures :
  1. Forearm and biceps strength measured by maximal isometric muscle strength [ Time Frame: Change from Pre to post intervention. ]


Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04154306


Contacts
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Contact: Mette Hansen +4551666551 mhan@ph.au.dk
Contact: Mikkel Oxfeldt +4520707078 mox@ph.au.dk

Locations
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Denmark
Aarhus University, Department for Public Health, Section for Sport Science Recruiting
Aarhus, Denmark, 8000
Contact: Mette Hansen, PhD    +4551666551    mhan@ph.au.dk   
Sponsors and Collaborators
University of Aarhus

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Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT04154306     History of Changes
Other Study ID Numbers: Estrogen_2019
First Posted: November 6, 2019    Key Record Dates
Last Update Posted: November 6, 2019
Last Verified: October 2019

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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
Keywords provided by University of Aarhus:
Isoflavones
Red clover
Muscle Function
Postmenopausal women