- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04154306
Effects of Fermented Red Clover on Muscle Strength and Muscle Mass
November 3, 2020 updated by: University of Aarhus
Effects of Fermented Red Clover on Muscle Strength and Muscle Protein Signaling in Postmenopausal Women
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
10
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Aarhus, Denmark, 8000
- Aarhus University, Department for Public Health, Section for Sport Science
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
|
2 weeks of Placebo
|
Experimental: Red clover
|
2 weeks of Red clover
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Change from pre to 3 hours post training
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Forearm and biceps strength measured by maximal isometric muscle strength
Time Frame: Change from Pre to post intervention.
|
Change from Pre to post intervention.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 1, 2019
Primary Completion (Actual)
December 17, 2019
Study Completion (Actual)
November 1, 2020
Study Registration Dates
First Submitted
October 31, 2019
First Submitted That Met QC Criteria
November 4, 2019
First Posted (Actual)
November 6, 2019
Study Record Updates
Last Update Posted (Actual)
November 4, 2020
Last Update Submitted That Met QC Criteria
November 3, 2020
Last Verified
October 1, 2019
More Information
Terms related to this study
Other Study ID Numbers
- Estrogen_2019
Drug and device information, study documents
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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