Effects of Fermented Red Clover on Muscle Strength and Muscle Mass

Sponsor

University of Aarhus (Other)

Overall Status

Completed

CT.gov ID

NCT04154306

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

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	N/A

Study Design

Study Type:

Interventional

Actual 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

Actual Study Start Date :

Nov 1, 2019

Actual Primary Completion Date :

Dec 17, 2019

Actual Study Completion Date :

Nov 1, 2020

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Muscle protein signalling measured by western blotting [Change from pre to 3 hours post training]
Change in protein content between two time points

Secondary Outcome Measures

Forearm and biceps strength measured by maximal isometric muscle strength [Change from Pre to post intervention.]

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 65 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Aarhus University, Department for Public Health, Section for Sport Science	Aarhus		Denmark	8000

Sponsors and Collaborators

University of Aarhus

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Aarhus

ClinicalTrials.gov Identifier:

NCT04154306

Other Study ID Numbers:

Estrogen_2019

First Posted:

Nov 6, 2019

Last Update Posted:

Nov 4, 2020

Last Verified:

Oct 1, 2019

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by University of Aarhus

Study Results

No Results Posted as of Nov 4, 2020