Effects of Fermented Red Clover on Muscle Strength and Muscle Mass

NCT04154306 | Completed

• 1 other identifier: Estrogen_2019
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Estrogen Deficiency

Keywords

Isoflavones; Red clover; Muscle Function; Postmenopausal women

Outcome Measures

Primary Outcomes (1)

• Muscle protein signalling measured by western blotting

  Change in protein content between two time points

  Change from pre to 3 hours post training

Secondary Outcomes (1)

• Forearm and biceps strength measured by maximal isometric muscle strength

  Change from Pre to post intervention.

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Dietary Supplement: Placebo

Red clover

EXPERIMENTAL

Dietary Supplement: Red clover

Interventions

Red clover DIETARY_SUPPLEMENT

2 weeks of Red clover

Red clover

Placebo DIETARY_SUPPLEMENT

2 weeks of Placebo

Placebo

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• maximum of 5 years since last menstrual bleeding
• Minimum of 6 months since last menstrual bleeding

You may not qualify if:

• Performed systematic resistance training within the last 6 months
• Smoker
• Using any form of medicine influencing the effects of resistance training

Sponsors & Collaborators

• University of Aarhus: lead

Study Sites (1)

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

Aarhus, 8000, Denmark

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2019
• First Posted: November 6, 2019
• Study Start: November 1, 2019
• Primary Completion: December 17, 2019
• Study Completion: November 1, 2020
• Last Updated: November 4, 2020

Record last verified: 2019-10

Locations

DK (1)