Effects of Fermented Red Clover on Muscle Strength and Muscle Mass

Estrogen Deficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04154306
• Other study ID #: Estrogen_2019
• Status: Completed
• Phase: N/A
• Start date: November 1, 2019
• Est. completion date: November 1, 2020

Study information

• Verified date: October 2019
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: November 1, 2020
• Est. primary completion date: December 17, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 40 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Estrogen Deficiency

Intervention

Dietary Supplement:
• Red clover
2 weeks of Red clover
• Placebo
2 weeks of Placebo

Locations

Country	Name	City	State
Denmark	Aarhus University, Department for Public Health, Section for Sport Science	Aarhus

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Muscle protein signalling measured by western blotting	Change in protein content between two time points	Change from pre to 3 hours post training
Secondary	Forearm and biceps strength measured by maximal isometric muscle strength		Change from Pre to post intervention.