Effect of Time-restricted Eating on Cognitive Function and Other Biopsychosocial Factors in Menopausal Women Undertaking a 12-week Exercise Programme
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- LDL-cholesterol
研究概览
简要总结
The goal of this quasi-experimental study is to test effect of time-restricted eating on cognitive function and other biopsychosocial factors in menopausal women undertaking a 12-week exercise programme. The main questions to answer are:
- What is effect of time-restricted eating on cognitive function in menopausal women undertaking a 12-week exercise programme?
- What is effect of time-restricted eating on menopausal symptoms in menopausal women undertaking a 12-weeks exercise programme?
- What is effect of time-restricted eating on metabolic health parameters in menopausal women undertaking a 12-weeks exercise programme?
Participants of both groups will have moderate intensity circuit mixed endurance and resistance exercise programme two times per week for 55 minutes for 12 weeks. Participants of one of two groups will not only exercise but also have a time-restricted eating following 16:8 protocol for 12 weeks.
Participants will have pre-tests and post-tests:
- blood samples collection (to measure level of brain-derived neurotrophic factor, glial cell derived neurotrophic factor, insulin, glucose, lipid profile),
- body composition analysis,
- Stroop test and N-back test,
- electroencephalography using Emotiv Epic X devices,
- One-repetition maximum test, Ruffier test,
- Questionnaire assessment (using Menopause Rating Scale and The Menopause-Specific Quality of Life Questionnaire).
Researchers will compare two groups - exercise group and combination group which will do both time-restricted eating and exercise to see if there is a modulating effect of time-restricted eating in participants undertaking exercise.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 41 Years 至 61 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •perimenopause, menopause or post-menopause
- •lightly physically active or physically inactive
排除标准
- •using hormone replacement therapy or hormonal contraception
- •having significant contraindications to physical exercise or time-restricted eating
结局指标
主要结局
LDL-cholesterol
时间窗: Before and after 12-week intervention
Level of cholesterol LDL in mg/dl
N-back test
时间窗: Before and after 12-week intervention
Cognitive functions assessment with N-back test in points. Higher scores means better outcome.
Glucose
时间窗: Before and after 12-week intervention
Level of glucose in mg/dl
Muscle mass
时间窗: Before and after 12-week intervention
Bioelectrical impedance analysis for estimating body composition, in particular muscle mass in kg
Brain-derived neurotrophic factor
时间窗: Before and after 12-week intervention
Level of brain-derived neurotrophic factor in ng/ml
Glial cell derived neurotrophic factor
时间窗: Before and after 12-week intervention
Level of glial cell derived neurotrophic factor in ng/ml
Insulin
时间窗: Before and after 12-week intervention
Level of insulin in μIU/ml
Fat mass
时间窗: Before and after 12-week intervention
Bioelectrical impedance analysis for estimating body composition, in particular fat mass in kg
One-repetition maximum test
时间窗: Before and after 12-week intervention
Strength assessment with one-repetition maximum test in kg
Menopause Rating Scale
时间窗: Before and after 12-week intervention
Menopausal symptoms assessment with Menopause Rating Scale in points. Minimum value is 0 and maximum value is 44. Higher score means worse outcome.
Ruffier test
时间窗: Before and after 12-week intervention
Cardiorespiratory fitness assessment with Ruffier test in points. Minimum value is 0, maximum value is 10. Higher score means worse outcome.
Stroop test
时间窗: Before and after 12-week intervention
Cognitive functions assessment with Stroop test in points. Higher scores means better outcome.
The Menopause-Specific Quality of Life Questionnaire
时间窗: Before and after 12-week intervention
Menopausal symptoms assessment with The Menopause-Specific Quality of Life Questionnaire in points. Minimum value is 0 and maximum value is 174. Higher score means worse outcome.
Electroencephalography
时间窗: Before and after 12-week intervention
Measurement of brain waves (alpha, beta, gamma, theta) to assess electrical activity of the brain using Emotiv Epoc X device
次要结局
未报告次要终点