Investigating the Effects of Omega-3 Fatty Acid Multinutrient Supplement and Exercise on Mobility and Cognition in Older Women
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Change in habitual gait speed
研究概览
简要总结
The study will provide insight into how lifestyle-related interventions, specifically nutrition and exercise can impact the health of older women. The study uses a unique combination of interventions and encapsulates overall health outcomes by measuring both mobility and cognitive function.
The study examines the effects of a combined omega-3 polyunsaturated fatty acid (PUFA) and multi-nutrient supplement on measures of mobility and cognition in women aged 60 years and above. Volunteers for the study will be randomly assigned to one of four groups which are as follows:
- Omega-3 PUFA multi-nutrient supplement and aerobic exercise
- Omega-3 PUFA multi-nutrient supplement and no exercise
- Placebo supplement and aerobic exercise
- Placebo supplement and no exercise
Volunteers undertake the dietary supplementation for a period of 24 weeks. The active dietary supplement contains a daily dosage of 1 g docosahexaenoic acid, 160 mg eicosapentaenoic acid, 240 mg Ginkgo biloba, 60 mg phosphatidylserine, 20 mg d-α tocopherol, 1 mg folic acid, and 20 µg vitamin B12. The placebo supplement contains an iso-calorific oil blend that is typical of the current UK diet. The aerobic exercise consists of two classes per week the final 12 weeks of the study on stationary spinning exercise bikes.
Volunteers attend testing at the beginning and after 24 weeks. Verbal memory, spatial working memory, executive function and processing speed are assessed via a battery of cognitive tests. Mobility testing comprises three walking tests, some under single and dual task paradigms, as well as the five times sit to stand test, a measure of dynamic balance and functional mobility. Volunteers also provide two blood samples, one for fatty acids analysis and the other serum homocysteine levels. Participants also complete health-related quality of life questionnaire, the short form 36 (SF36) questionnaire, food diary and food frequency questionnaire.
详细描述
Design and Setting:
The study is a randomized semi-blinded, placebo-controlled trial in females aged 60 years and over. The study examines the effects of a high docosahexaenoic acid omega-3 PUFA multi-nutrient dietary supplement and aerobic exercise, both on their own and in combination, on outcomes related to mobility and cognition. All measurements and data collection, as well as the aerobic exercise, take place at the same study site (Bournemouth University, United Kingdom), with participants instructed to consume the dietary supplement at home.
Blinding Randomization and Allocation:
The dietary supplements are packed in identical containers and coded by the Principal Investigator, who has no involvement in the data collection. Omega-3 PUFA capsules have a distinct odor, therefore a small amount of fish oil is added to the placebo capsules to help maintain blinding. A stratified block randomization design is followed with stratification based on frailty classification of non-frail or pre-frail, followed by permuted block randomization. Randomization is achieved by creating a computer-generated list of numbers consisting of four blocks for each stratum referred to without specification of the intervention group (e.g., A, B, C, and D). The list is generated and stored by the Principal Investigator. Due to the nature of the exercise intervention participants are only be blinded to the dietary intervention; however, the experimenters are blinded to the exercise group allocations.
Participants:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Participants blinded to dietary intervention, but not exercise. Outcomes assessor blinded to both intervention and exercise group.
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Able to walk 50 meters unassisted
- •Non-frail or pre-frail according to Fried frailty phenotype
排除标准
- •Vestibular impairments
- •Diagnosed neurological disorder
- •Mini mental state examination score of ≤24
- •History of lower limb surgery
- •Seafood allergy
- •Regular consumption of multivitamin/fish oil supplements within six months prior to baseline measurements
- •Previously received advice from a health care professional to not take part in strenuous exercise.
研究组 & 干预措施
Efamol Active 50+ and exercise
Efamol Active 50+ Multinutrient supplement and aerobic exercise
干预措施: Aerobic exercise (Behavioral)
Efamol Active 50+ and exercise
Efamol Active 50+ Multinutrient supplement and aerobic exercise
干预措施: Efamol Active 50+ (Dietary Supplement)
Efamol Active 50+ and non-exercise
Efamol Active 50+ Multinutrient supplement and non-aerobic exercise
干预措施: Efamol Active 50+ (Dietary Supplement)
Placebo and exercise
Placebo supplement and aerobic exercise
干预措施: Aerobic exercise (Behavioral)
Placebo and exercise
Placebo supplement and aerobic exercise
干预措施: Placebo multinutrient (Dietary Supplement)
Placebo and non-exercise
Placebo supplement and non- exercise
干预措施: Placebo multinutrient (Dietary Supplement)
结局指标
主要结局
Change in habitual gait speed
时间窗: Baseline and 24 weeks post intervention
Habitual gait speed will be measured using inertial measurement sensors and will be expressed in m/s. Participants will be asked to walk at their normal habitual pace over 13 m. Acceleration and deceleration periods will automatically be excluded from analysis and the measure will be repeated five times with the mean value calculated.
次要结局
- Change in dual Task Cost(Baseline and 24 weeks post intervention)
- Change in executive function(Baseline and 24 weeks post intervention)
- Change in verbal memory(Baseline and 24 weeks post intervention)
- Change in processing speed(Baseline and 24 weeks post intervention)
- Change in spatial working memory(Baseline and 24 weeks post intervention)
- Change in fast walking speed(Baseline and 24 weeks post intervention)
- Change in dual task walking speed(Baseline and 24 weeks post intervention)
- Change in five times sit to stand(Baseline and 24 weeks post intervention)
- Change in physical functioning from short form 36 questionnaire(Baseline and 24 weeks post intervention)
- Change in emotional well-being from short form 36 questionnaire(Baseline and 24 weeks post intervention)
- Change in general health perceptions from short form 36 questionnaire(Baseline and 24 weeks post intervention)
- Change in bodily pain from short form 36 questionnaire(Baseline and 24 weeks post intervention)
- Change in role limitations due to physical health problems from short form 36 questionnaire(Baseline and 24 weeks post intervention)
- Change in role limitations due to personal or emotional problems from short form 36 questionnaire(Baseline and 24 weeks post intervention)
- Change in social functioning from short form 36 questionnaire(Baseline and 24 weeks post intervention)
- Change in energy/fatigue from short form 36 questionnaire(Baseline and 24 weeks post intervention)
研究者
Simon Dyall
Principal Academic
Bournemouth University