The Effects of Dietary Supplements on Health and Wellbeing in Middle Aged Women
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Cognitive function
研究概览
简要总结
This study will examine the effects of combining different types of dietary supplements on various aspects of health and wellbeing in middle aged women. The main outcomes of the trial will be aspects of health and wellbeing that middle aged women report as increasingly problematic, such as joint pain, fatigue, sleep, and changes in body composition, strength, and inflammation. Participants will consume the supplement(s) or placebo for 8 weeks, and outcome measures will be assessed before and after supplementation.
详细描述
Participants will be randomised to receive either creatine or maltodextrin to be taken daily for 8 weeks. Participants will first attend a familiarisation visit where consent will be given and cognitive function tests will be practised (letter comparison, backwards digit span test, and stroop color word tests). Participants will complete a 3-day food record diary before attending Visit 2. In Visit 2, participants will complete a range of questionnaires assessing physical activity, quality of life, sleep, menstrual cycle/menopause status and symptoms. Stature and body composition will be recorded. Blood pressure, augmentation index, and handgrip strength will be measured. Venous blood samples will be collected for later measures of inflammation, joint health, and fatty acid blood profile. Joint pain (under 3 conditions) and fatigue will be assessed using a 100mm Visual Analogue Scale. Gastrointestinal comfort will be rated using a Likert scale. Participants will be provided with another food record diary to complete 3 days prior to visit 3, and they will be given their supplements to consume for 8 weeks and a supplement log to track intake of supplements/medication. Visit 3 will occur 8 weeks after Visit 2 and it will follow the same format as Visit 2. Statistical analysis will be performed with linear mixed model and independent t-tests. Sample sizes are based on a prior estimations for these methods of analysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Aged 35-65 years old
- •Healthy, free from known disease
- •Non-smoker
- •BMI 18-30 kg/m2
- •Classified as recreationally active (meet the WHO guidelines for physical activity: complete at least 150-300 minutes of moderate intensity activity or 75-150 minutes of vigorous intensity activity a week, plus muscle strengthening activities 2 or more days a week) OR sedentary (do not meet the minimum activity guidelines but do occasional and/or incidental physical activity, e.g., walking to work, household activities).
排除标准
- •Currently have a musculoskeletal injury or diagnosed condition (CVD, osteoarthritis, diabetes, cancer, metabolic syndrome, uncontrolled hypertension, gastrointestinal disease, blood clotting disorder)
- •Regularly taking prescription medication initiated in the last 3 months or unstable
- •Have initiated hormone replacement therapy within the last 3 months or unstable
- •Have an allergy to ingredients in the supplements or standardised breakfast
- •Pregnant or breastfeeding, or any other contradictions to consuming the study supplements
- •Lost more than 10% of body mass in the past 6 months or plan on trying to lose body mass during trial period
- •Currently consuming the supplements being investigated and unwilling to stop
- •Any known cognitive or visual impairments limiting ability to perform cognitive tests
- •Unwilling to maintain current diet and physical activity levels and report any change in health status
结局指标
主要结局
Cognitive function
时间窗: 8 weeks
Participants will complete 3 cognitive function tests on a laptop in a quiet room: the Letter Comparison test (measuring reaction time (ms) and accuracy (%)), the Backwards Digit Span test (measuring the longest correct span score), and the Stroop Colour Word test (measuring congruent/incongruent/neutral reaction time (ms) and accuracy (%), and the Interference Effect (calculated as incongruent reaction time - congruent reaction time).
次要结局
- Body composition measured using bioelectrical impedance analysis (BIA)(8 weeks)
- Hand grip strength dynamometry (kg)(8 weeks)
- Blood pressure (mmHg)(8 weeks)
- Augmentation index(8 weeks)
- Fatigue under 2 conditions measured by a 100 mm visual analogue scale (VAS)(8 weeks)
- Sleep quality measured by Athens Insomnia Scale and a simple Sleep Quality Scale(8 weeks)
- Quality of life assessed by the 36-Item Short Form Survey Instrument (SF-36)(8 weeks)
- Gastrointestinal comfort measure via a Likert Scale under 3 conditions(8 weeks)
- Menstrual cycle/menopause symptom questionnaire(8 weeks)
- Joint pain assessed via a 100mm visual analogue scale (VAS)(8 weeks)
研究者
Tom Clifford
Reader in Exercise and Health Nutrition
Loughborough University