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Effects of Fermented Red Clover on Muscle Strength and Muscle Mass

NCT ID: NCT04154306

Last Updated: 2020-11-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-01

Study Completion Date

2020-11-01

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.

Detailed Description

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Conditions

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Estrogen Deficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

2 weeks of Placebo

Red clover

Group Type EXPERIMENTAL

Red clover

Intervention Type DIETARY_SUPPLEMENT

2 weeks of Red clover

Interventions

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Red clover

2 weeks of Red clover

Intervention Type DIETARY_SUPPLEMENT

Placebo

2 weeks of Placebo

Intervention Type DIETARY_SUPPLEMENT

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
Minimum Eligible Age

40 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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

Aarhus, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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Estrogen_2019

Identifier Type: -

Identifier Source: org_study_id