Trials / Recruiting
RecruitingNCT07135232
The Effects of Resistance Training and a Plant-Based Supplement on Perimenopausal Symptoms and Muscle Health.
The Effects of Resistance Training and a Sarmentosin - L-theanine Supplement on Perimenopausal Symptoms and Musculoskeletal Health: A Randomised Controlled Trial
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 72 (estimated)
- Sponsor
- Leeds Beckett University · Academic / Other
- Sex
- Female
- Age
- 40 Years – 55 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | Sarmentosin - L- theanine | Two capsules to give an overall dose of 20 mg of Sarmentosin and 400mg of L-theanine |
| OTHER | Resistance Training | Home-based Resistance training. Exercises will target the lower and upper body and utilise body weight, resistance bands, dumbbells and push-up handles. |
| DIETARY_SUPPLEMENT | Placebo Supplement | Capsules matched for taste and appearance, without any active ingredients. |
Timeline
- Start date
- 2026-03-01
- Primary completion
- 2027-03-01
- Completion
- 2027-04-01
- First posted
- 2025-08-22
- Last updated
- 2026-03-27
Locations
1 site across 1 country: United Kingdom
Source: ClinicalTrials.gov record NCT07135232. Inclusion in this directory is not an endorsement.