Actively Recruiting

Phase Not Applicable
Age: 40Years - 55Years
FEMALE
Healthy Volunteers
NCT07135232

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

Led by Leeds Beckett University · Updated on 2026-03-27

72

Participants Needed

1

Research Sites

56 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 40Years - 55Years
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Perimenopausal women between 40 - 55 years
  • Not currently engaging in consistent structured resistance training (more than 3 sessions per week for 4 consecutive weeks in the past 6 months)
  • Not on hormone replacement therapy or hormonal contraception for at least one year before the study
  • Able to attend laboratory visits and commit to the intervention schedule for 6 months
  • Willing to provide blood samples
  • Not regularly consuming supplements containing concentrated Sarmentosin, L-theanine, or compounds that may interfere with the study
  • Willing to limit dietary intake of Sarmentosin (e.g., Blackcurrant) and L-theanine (e.g., green or black tea)
  • Willing and able to provide written informed consent
Not Eligible

You will not qualify if you...

  • Diagnosed cardiovascular disease, uncontrolled hypertension (above 160/100 mmHg), or other conditions preventing safe exercise
  • Clinically diagnosed mental health disorders such as bipolar disorder, schizophrenia, or severe depression requiring medication adjustment within the last 6 months
  • Neurological conditions affecting cognitive function like Parkinson's disease, multiple sclerosis, or epilepsy
  • Endocrine disorders impacting hormonal fluctuations or metabolism, such as uncontrolled diabetes or thyroid dysfunction
  • History of major musculoskeletal injuries (fractures, joint replacement) within the past 6 months
  • Regular use of medications interfering with study outcomes including antidepressants, corticosteroids, or beta-blockers
  • Obesity (BMI over 30 or over 27.5 for South Asian ethnicity)
  • Food allergy or intolerance to study products
  • Use of illicit drugs
  • Alcohol intake exceeding 14 standard units per week (about 6 standard drinks)
  • Pregnant or planning to conceive during the trial
  • High habitual caffeine intake (over 400 mg/day, about 4-5 cups of coffee)

AI-Screening

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Trial Site Locations

Total: 1 location

1

Carnegie School of Sport

Leeds, North Humberside, United Kingdom, LS2 3AE

Actively Recruiting

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Research Team

H

Harriet Cannell

CONTACT

T

Theocharis Ispogolou

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

4

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