The Effects of Resistance Training and a Sarmentosin - L-theanine Supplement on Perimenopausal Symptoms and Musculoskeletal Health: A Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Depressive Symptom Score at week 4
研究概览
简要总结
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:
- 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)?
- 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)?
- 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:
- The nutritional supplement + resistance training
- The nutritional supplement only
- The placebo supplement (A look alike capsule that contains no active ingredients) and resistance training
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
盲法说明
Masking will only be applied to supplement allocation. All parties will be aware of their exercise allocation.
入排标准
- 年龄范围
- 40 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
Placebo Supplement Only
Two placebo capsules to be consumed by participants daily
干预措施: Placebo Supplement (Dietary Supplement)
Placebo Supplement and Resistance Training
Participants will consume two placebo supplements daily, and perform structured resistance training three times per week.
干预措施: Resistance Training (Other)
Placebo Supplement and Resistance Training
Participants will consume two placebo supplements daily, and perform structured resistance training three times per week.
干预措施: Placebo Supplement (Dietary Supplement)
Active Supplement Only
Participants will consume two capsules of the Sarmentosin - L-theanine supplement daily.
干预措施: Sarmentosin - L- theanine (Dietary Supplement)
Active Supplement and Resistance Training
Participants will consume two capsules of the Sarmentosin - L-theanine supplement daily and perform structured resistance training three times per week.
干预措施: Resistance Training (Other)
Active Supplement and Resistance Training
Participants will consume two capsules of the Sarmentosin - L-theanine supplement daily and perform structured resistance training three times per week.
干预措施: Sarmentosin - L- theanine (Dietary Supplement)
结局指标
主要结局
Depressive Symptom Score at week 4
时间窗: 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.
Depressive Symptom Score at Week 8
时间窗: 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.
Change in Sustained Attention Pre- to Post-Supplement Intake at Week 1
时间窗: Pre- to 1 hour post- supplement intake at week 1 of the intervention.
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.
Change in Sustained Attention Pre- to Post-Supplement Intake at Week 12
时间窗: Pre- to 1 hour post- supplement intake at week 12 of the intervention.
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.
Depressive Symptom Score at Week 12
时间窗: 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.
次要结局
- Verbal Episodic Memory Performance at Week 12(Week 12)
- Verbal Episodic Memory Performance at Week 8(Week 8)
- Verbal Episodic Memory Performance at Week 4(Week 4)
- Spatial Planning and Working Memory Performance at Week 12(Week 12)
- Working Memory Performance at Week 4(Week 4)
- Working Memory Performance at Week 8(Week 8)
- Working Memory Performance at Week 12(Week 12)
- Spatial Planning and Working Memory Performance at Week 4(Week 4)
- Spatial Planning and Working Memory Performance at week 8(Week 8)
- Sustained Attention Performance at Week 4(Week 4)
- Sustained Attention Performance at Week 12(Week 12)
- Sustained Attention Performance at week 8(Week 8)
- Subjective Memory Complaints at Week 4(Week 4)
- Subjective Memory Complaints at Week 8(Week 8)
- Subjective Memory Complaints at Week 12(Week 12)
- Self-reported Sleep Quality at Week 4(Week 4)
- Self-reported Sleep Quality at Week 8(Week 8)
- Self-reported Sleep Quality at Week 12(Week 12)
- Self-reported Hot Flash Severity and Frequency at Week 4(Week 4)
- Self-reported Hot Flash Severity and Frequency at Week 8(Week 8)
- Self-reported Hot Flash Severity and Frequency at Week 12(Week 12)
- Anxiety Symptoms at Week 4(Week 4)
- Anxiety Symptoms at Week 8(Week 8)
- Anxiety Symptoms at Week 12(Week 12)
- Stress symptoms at Week 4(Week 4)
- Stress Symptoms at Week 8(Week 8)
- Stress Symptoms at Week 12(Week 12)
- Quality of Life Score at Week 4(Week 4)
- Quality of Life Score at Week 8(Week 8)
- Quality of Life Score at Week 12(Week 12)
- Change in Handgrip Strength from baseline to Week 12(Baseline and Week 12)
- change in Leg Extensor Submaximal Strength from baseline to Week 12(Baseline and Week 12)
- Change in Isometric Mid-thigh Pull Strength from baseline to Week 12(Baseline and Week 12)
- Change in the Number of Reps Completed in the 30 Second Sit-to-stand Test from baseline to week 12(baseline and Week 12)
- Change in Appendicular Lean Mass from baseline to Week 12(Baseline and Week 12)
- Felt-affect Visual Analogue score at week 4(Week 4)
- Felt-affect Visual Analogue score at week 8(Week 8)
- Felt-affect Visual Analogue score at week 12(Week 12)
- Exercise Enjoyment at week 1(Week 1)
- Exercise Enjoyment at week 4(Week 4)
- Exercise Enjoyment at week 8(Week 8)
- Exercise Enjoyment at week 12(Week 12)
- Change in Verbal Episodic Memory Performance from Pre- to Post-Supplement Intake in Week 1.(Pre- to 1 hour post- supplement intake in week 1)
- Change In Working Memory Performance From Pre- to Post-Supplement Intake in Week 12.(Pre- to 1 hour post- supplement intake in week 12)
- Change in Verbal Episodic Memory Performance From Pre- to Post-Supplement Intake in Week 12(Pre- to 1 hour post- supplement intake in week 12)
- Change in Working Memory Performance From Pre- to Post-Supplement Intake in Week 1(Pre- to 1 hour post- supplement intake in week 1)
- Change in Spatial Planning and Working Memory Performance From Pre- to Post-Supplement Intake in Week 1.(Pre- to 1 hour post- supplement intake in week 12)
- Change in Mood State From Pre- to Post- Supplement Intake in week 1(Pre- to 1 hour post- supplement intake in week 1.)
- Change in total body fat percentage from baseline to Week 12(Baseline and Week 12)
- Change in Mood State From Pre- to Post- Supplement Intake in Week 12(Pre- to 1 hour post- supplement intake in week 12)
- Change in Spatial Planning and Working Memory Performance From Pre- to Post-Supplement Intake in Week 1.(Pre- to 1 hour post- supplement intake in week 1.)
研究者
Harriet Cannell
Doctoral Researcher
Leeds Beckett University