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

Leeds Beckett University

Status: Not yet enrolling

Conditions: Menopause; Perimenopause

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

Study type: Interventional

Funder types: Other

Identifiers

NCT07135232

AM004156

Details and patient eligibility

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.

Enrollment: 72 estimated patients

Sex: Female

Ages: 40 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria

1. Perimenopausal women between 40 - 55 years
2. 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).
3. Not on any HRT or hormonal contraception for at least one year before initiation of the study.
4. Able to attend laboratory visits and commit to the intervention schedule for 6 months.
5. Willing to provide blood samples
6. Not regularly consuming any dietary supplements containing concentrated sarmentosin, L-theanine or other compounds that may interfere with the study intervention.
7. Willing to limit dietary intake of Sarmentosin (e.g. Blackcurrant) and L-theanine (e.g. green tea/ black tea).
8. Willing and able to provide written informed consent

Exclusion criteria

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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72 participants in 4 patient groups, including a placebo group

Placebo Supplement Only

Placebo Comparator group

Description:

One placebo capsule to be consumed by participants daily

Treatment:

Dietary Supplement: Placebo Supplement

Placebo Supplement and Resistance Training

Experimental group

Description:

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

Treatment:

Dietary Supplement: Placebo Supplement

Other: Resistance Training

Active Supplement Only

Experimental group

Description:

Participants will consume one capsule of the Sarmentosin - L-theanine supplement daily.

Treatment:

Dietary Supplement: Sarmentosin - L- theanine

Active Supplement and Resistance Training

Experimental group

Description:

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

Treatment:

Dietary Supplement: Sarmentosin - L- theanine

Other: Resistance Training