The Effects of Resistance Training and a Plant-Based Supplement on Perimenopausal Symptoms and Muscle Health.

Sponsor
Leeds Beckett University
Study ID
NCT07135232
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
FEMALE
Age
40 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • Sarmentosin - L- theanine — DIETARY_SUPPLEMENT
    Two capsules to give an overall dose of 20 mg of Sarmentosin and 400mg of L-theanine
  • Resistance Training — OTHER
    Home-based Resistance training. Exercises will target the lower and upper body and utilise body weight, resistance bands, dumbbells and push-up handles.
  • Placebo Supplement — DIETARY_SUPPLEMENT
    Capsules matched for taste and appearance, without any active ingredients.

Study Details

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.

Key Dates

First listed
Aug 22, 2025
Start date
Mar 1, 2026
Status verified
Mar 2026
Primary completion
Mar 1, 2027
Completion
Apr 1, 2027

Study Design

Enrollment
72 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • 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.

Primary Outcome Measure

Depressive Symptom Score at week 4 [ Time Frame: Week 4 ]

Central Contacts

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