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The Effects of Resistance Training and a Sarmentosin - L-theanine Supplement on Perimenopausal Symptoms and Musculoskeletal Health: A Randomised Controlled Trial

Status: Recruiting
Location: See location...
Intervention Type: Dietary supplement, Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The aim of this clinical trial is to determine if resistance training and a newly developed plant-based nutritional supplement can improve the symptoms and musculoskeletal health of perimenopausal women. The main questions it aims to evaluate are: 1. Can resistance training and the nutritional supplement - both independently and in combination - improve perimenopausal symptoms (e.g. cognition, mood, sleep) and musculoskeletal outcomes (e.g. strength, muscle mass)? 2. What are the acute effects of the nutritional supplement on cognitive function and mood in perimenopausal women, and is this response altered following long-term intake (12 weeks)? 3. What mechanisms may be contributing to the results? Participants will be split into four groups to allow the researchers to answer the above questions. These are: 1. The nutritional supplement + resistance training 2. The nutritional supplement only 3. The placebo supplement (A look alike capsule that contains no active ingredients) and resistance training 4. The Placebo supplement only. Participants will: * Take their allocated supplement daily and perform home-based strength exercise 3 times per week (for exercise groups), for 12 weeks. * Attend the laboratory at the beginning and end of the 12 weeks to assess cognitive function and mood following acute intake of the supplement. * Attend the laboratory every 4 weeks during the 12 week period, for assessment of cognitive function, symptom severity and muscle health. * Provide a blood sample at each visit for assessment of mechanistic pathways.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 40
Maximum Age: 55
Healthy Volunteers: t
View:

• Perimenopausal women between 40 - 55 years

• Not currently engaging in consistent structured resistance training (defined as \>3 resistance training sessions per week for 4 consecutive weeks, in the past six months).

• Not on any HRT or hormonal contraception for at least one year before initiation of the study.

• Able to attend laboratory visits and commit to the intervention schedule for 6 months.

• Willing to provide blood samples

• Not regularly consuming any dietary supplements containing concentrated sarmentosin, L-theanine or other compounds that may interfere with the study intervention.

• Willing to limit dietary intake of Sarmentosin (e.g. Blackcurrant) and L-theanine (e.g. green tea/ black tea).

• Willing and able to provide written informed consent

Locations
Other Locations
United Kingdom
Carnegie School of Sport
RECRUITING
Leeds
Contact Information
Primary
Harriet Cannell
H.cannell@leedsbeckett.ac.uk
+447805576688
Backup
Theocharis Ispogolou
T.Ispoglou@leedsbeckett.ac.uk
Time Frame
Start Date: 2026-03-01
Estimated Completion Date: 2027-04-01
Participants
Target number of participants: 72
Treatments
Placebo_comparator: Placebo Supplement Only
Two placebo capsules to be consumed by participants daily
Experimental: Placebo Supplement and Resistance Training
Participants will consume two placebo supplements daily, and perform structured resistance training three times per week.
Experimental: Active Supplement Only
Participants will consume two capsules of the Sarmentosin - L-theanine supplement daily.
Experimental: Active Supplement and Resistance Training
Participants will consume two capsules of the Sarmentosin - L-theanine supplement daily and perform structured resistance training three times per week.
Related Therapeutic Areas
Sponsors
Leads: Leeds Beckett University

This content was sourced from clinicaltrials.gov