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

NCT07135232 | Recruiting

• 1 other identifier: AM004156
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief 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:

• 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

Perimenopause; Menopause

Keywords

Mood; Depression; Cognition; Resistance Training; Sarmentosin - L-theanine; Bioactive supplement; perimenopause symptoms; menopause; lifestyle; muscle; health; exercise; perimenopause; symptoms; hot flashes; vasomotor; anxiety; stress

Outcome Measures

Primary Outcomes (5)

• Depressive Symptom Score at week 4

  Assessed using the depressive sub-scale of the Depression, Anxiety and stress scale - 21 items. Assessed on a scale from 0 - 3 over 7 questions, with a maximum score of 42. Higher scores indicate more severe depressive symptoms.

  Week 4

• Depressive Symptom Score at Week 8

  Assessed using the depressive sub-scale of the Depression, Anxiety and stress scale - 21 items. Assessed on a scale from 0 - 3 over 7 questions, with a maximum score of 42. Higher scores indicate more severe depressive symptoms.

  Week 8

• Depressive Symptom Score at Week 12

  Assessed using the depressive sub-scale of the Depression, Anxiety and stress scale - 21 items. Assessed on a scale from 0 - 3 over 7 questions, with a maximum score of 42. Higher scores indicate more severe depressive symptoms.

  Week 12

• Change in Sustained Attention Pre- to Post-Supplement Intake at Week 1

  Assessed as the signal detection measure of a subject's sensitivity to the target sequence (A') during the Cambridge Neuropsychological Test Automated Battery rapid visual information processing test.

  Pre- to 1 hour post- supplement intake at week 1 of the intervention.

• Change in Sustained Attention Pre- to Post-Supplement Intake at Week 12

  Assessed as the signal detection measure of a subject's sensitivity to the target sequence (A') during the Cambridge Neuropsychological Test Automated Battery rapid visual information processing test.

  Pre- to 1 hour post- supplement intake at week 12 of the intervention.

Secondary Outcomes (51)

• Verbal Episodic Memory Performance at Week 4

  Week 4

• Verbal Episodic Memory Performance at Week 8

  Week 8

• Verbal Episodic Memory Performance at Week 12

  Week 12

• Working Memory Performance at Week 4

  Week 4

• Working Memory Performance at Week 8

  Week 8

Other Outcomes (21)

• A Panel of Serum Steroid Hormones (e.g. Oestradiol, Progesterone, Testosterone and Cortisol) at Week 4

  Week 4

• A Panel of Serum Steroid Hormones (e.g. Oestradiol, Progesterone, Testosterone and Cortisol) at Week 8

  Week 8

• A Panel of Serum Steroid Hormones (e.g. Oestradiol, Progesterone, Testosterone and Cortisol) at Week 12

  Week 12

Study Arms (4)

Placebo Supplement Only

PLACEBO COMPARATOR

Two placebo capsules to be consumed by participants daily

Dietary Supplement: Placebo Supplement

Placebo Supplement and Resistance Training

EXPERIMENTAL

Participants will consume two placebo supplements daily, and perform structured resistance training three times per week.

Other: Resistance Training; Dietary Supplement: Placebo Supplement

Active Supplement Only

EXPERIMENTAL

Participants will consume two capsules of the Sarmentosin - L-theanine supplement daily.

Dietary Supplement: Sarmentosin - L- theanine

Active Supplement and Resistance Training

EXPERIMENTAL

Participants will consume two capsules of the Sarmentosin - L-theanine supplement daily and perform structured resistance training three times per week.

Dietary Supplement: Sarmentosin - L- theanine; Other: Resistance Training

Interventions

Sarmentosin - L- theanine DIETARY_SUPPLEMENT

Two capsules to give an overall dose of 20 mg of Sarmentosin and 400mg of L-theanine

Active Supplement Only; Active Supplement and Resistance Training

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.

Also known as: Strength Training, Resistance Exercise, Strength Exercise

Active Supplement and Resistance Training; Placebo Supplement and Resistance Training

Placebo Supplement DIETARY_SUPPLEMENT

Capsules matched for taste and appearance, without any active ingredients.

Placebo Supplement Only; Placebo Supplement and Resistance Training

Eligibility Criteria

• Age: 40 Years - 55 Years
• Gender Eligibility Details: Participants must have been assigned female at birth.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Diagnosed cardiovascular disease (CVD), uncontrolled hypertension (\>160/100 mmHg), or other conditions that prevent safe exercise participation.
• Clinically diagnosed mental health disorders (e.g., bipolar disorder, schizophrenia, severe depression requiring medication adjustment within the last 6 months).
• Neurological conditions affecting cognitive function (e.g., Parkinson's disease, multiple sclerosis, epilepsy).
• Endocrine disorders that could impact hormonal fluctuations or metabolism (e.g., uncontrolled diabetes, thyroid dysfunction).
• History of major musculoskeletal injuries (e.g., fractures, joint replacement) within the past 6 months
• Regular use of medications that could interfere with study outcomes, including antidepressants, corticosteroids, beta-blockers.
• Obesity (BMI \>30 or for South Asian Ethinicity BMI\> 27.5)
• Food allergy or intolerance to study products.
• Use of illicit drugs.
• Alcohol intake exceeding the government guidelines of 14 standard units per week (Equivalent of 6 standard drinks).
• Pregnant or planning to conceive during the trial.
• High habitual caffeine intake (\>400 mg/day which is approximately 4-5 cups of coffee)

Sponsors & Collaborators

• Leeds Beckett University: lead

Study Sites (1)

Carnegie School of Sport

Leeds, North Humberside, LS2 3AE, United Kingdom

RECRUITING

MeSH Terms

Conditions

Depression; Motor Activity; Hot Flashes; Anxiety Disorders

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Harriet Cannell

CONTACT

+447805576688; H.cannell@leedsbeckett.ac.uk

Theocharis Ispogolou

CONTACT

T.Ispoglou@leedsbeckett.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Masking will only be applied to supplement allocation. All parties will be aware of their exercise allocation.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctoral Researcher

Study Record Dates

• First Submitted: August 14, 2025
• First Posted: August 22, 2025
• Study Start: March 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: March 27, 2026

Record last verified: 2026-03

Locations

GB (1)