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

Официальное название

The Effects of Resistance Training and a Sarmentosin - L-theanine Supplement on Perimenopausal Symptoms and Musculoskeletal Health: A Randomised Controlled Trial

Обзор

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.

Вмешательства

• Пищевая добавка Sarmentosin - L- theanine
  Two capsules to give an overall dose of 20 mg of Sarmentosin and 400mg of L-theanine
• Другое 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.
• Пищевая добавка Placebo Supplement
  Capsules matched for taste and appearance, without any active ingredients.

Первичные конечные точки

• Depressive Symptom Score at week 4 [Срок оценки: Week 4]
• Depressive Symptom Score at Week 8 [Срок оценки: Week 8]
• Depressive Symptom Score at Week 12 [Срок оценки: Week 12]
• Change in Sustained Attention Pre- to Post-Supplement Intake at Week 1 [Срок оценки: 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 [Срок оценки: Pre- to 1 hour post- supplement intake at week 12 of the intervention.]

Вторичные конечные точки (12)

• Verbal Episodic Memory Performance at Week 4 [Срок оценки: Week 4]
• Verbal Episodic Memory Performance at Week 8 [Срок оценки: Week 8]
• Verbal Episodic Memory Performance at Week 12 [Срок оценки: Week 12]
• Working Memory Performance at Week 4 [Срок оценки: Week 4]
• Working Memory Performance at Week 8 [Срок оценки: Week 8]
• Working Memory Performance at Week 12 [Срок оценки: Week 12]
• Spatial Planning and Working Memory Performance at Week 4 [Срок оценки: Week 4]
• Spatial Planning and Working Memory Performance at week 8 [Срок оценки: Week 8]
• Spatial Planning and Working Memory Performance at Week 12 [Срок оценки: Week 12]
• Sustained Attention Performance at Week 4 [Срок оценки: Week 4]
• Sustained Attention Performance at week 8 [Срок оценки: Week 8]
• Sustained Attention Performance at Week 12 [Срок оценки: Week 12]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Поддерживающая терапия

Центры проведения

Великобритания · 1 центр

• Carnegie School of Sport — Leeds

Идентификаторы

NCT: NCT07135232 · AM004156

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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