Effects of Fermented Red Clover on Muscle Strength and Muscle Mass

Study Overview
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Brief Summary
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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.

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

Conditions
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Estrogen Deficiency

Intervention / Treatment
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* Dietary Supplement: Red clover
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br> | Dietary Supplement: Placebo<br>* 2 weeks of Placebo<br>|
| Experimental: Red clover<br> | Dietary Supplement: Red clover<br>* 2 weeks of Red clover<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Isoflavones, Red clover, Muscle Function, Postmenopausal women