Improving Everyday Functioning in Adults Aged 70 and Over Using a Multivitamin Supplement
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 228
- 试验地点
- 1
- 主要终点
- Overall Well-Being (change from baseline)
研究概览
简要总结
Investigation of the chronic effect of 12 week multivitamin supplementation on markers of everyday function in adults aged 70 and over.
详细描述
Everyday functioning relates to how well an individual can function independently in day-to-day life. As a person ages, there are various changes which occur in the body, which can lead to a decline in everyday functioning. There is a loss of bone density, the immune system naturally declines which can lead to a susceptibility to autoimmune diseases, infection and cardiovascular disease. Many older adults report feeling socially isolated and lonely, which can also lead to poor mood and negative health outcomes. Due to advancements in society, there has been an increase in older adult informal caregivers, which is a form of chronic stress associated with a range of negative outcomes and declines in functioning.
Nutritional supplementation may have the potential to improve everyday functioning in older adults, which may have declined through ageing alone or ageing alongside chronic stress from being a caregiver. Research had shown multivitamin supplementation to have positive cognitive, mood, mobility and health effects. As well as improving general day-to-day well-being and functioning, and may have the ability to reduce feeling of stress.
The current study will investigate the effects of a multivitamin supplement following daily intake for 12 weeks on a range of everyday functioning outcomes in adults aged 70 and over. The outcome measures include; well being, cardiovascular reactivity, immune response, stress, self-reported health, daily functioning behaviours, mobility, mood, cognitive function, sleep quality and loneliness.
Amendment to protocol:
The recent Covid-19 restrictions have led to changes to the original protocol. Specifically, a group of participants who completed their baseline assessment as per the outlined protocol could not complete the final testing visit as initially planned because of the imposed lockdown For these participants, all follow-up questionnaire-based assessments have been conducted online from their home.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged over 70
- •Both caregivers and non caregivers will be recrtuied
排除标准
- •Allergy to soya
- •Participants must not be currently taking the investigational product (or another equivalent multivitamin); any participants who report multivitamin use must be willing to have a washout for 4 weeks before participating (if not willing to do this they will be excluded)
- •If a participant has epilepsy, a thyroid disorder, haemochromatosis or suffers from food allergies they must consult their doctor/pharmacist before taking part
研究组 & 干预措施
Multivitamin
1 multivitamin tablet administered by mouth daily for 12 weeks, to be taken with main meal.
干预措施: Multivitamin (Dietary Supplement)
Placebo
1 placebo tablet administered by mouth daily for 12 weeks, to be taken with main meal.
干预措施: Placebo (Other)
结局指标
主要结局
Overall Well-Being (change from baseline)
时间窗: Measured at baseline and then following chronic (12 weeks) treatment
An overall outcome measure which is a composite measure made up of four personal well-being questions used in the Measuring National Well-being programme plus one additional question. These five questions are: 1. Overall, how satisfied are you with your life nowadays? 2. Overall, to what extent do you feel the things you do in your life are worthwhile? 3. Overall, how happy did you feel yesterday? 4. Overall, how anxious did you feel yesterday? 5. Overall, how well did you feel yesterday?
次要结局
- Self-Reported Stress (change from baseline)(Measured at baseline and then following chronic (12 weeks) treatment)
- Mood trait measures (change from baseline)(Measured at baseline and then following chronic (12 weeks) treatment)
- Acute measures of subjective state in responses to a stressor (change from baseline)(Measured at baseline and then following chronic (12 weeks) treatment)
- Cognitive function (change from baseline)(Measured at baseline and then following chronic (12 weeks) treatment)
- Mobility (change from baseline)(Measured at baseline and then following chronic (12 weeks) treatment)
- Mobility(change from baseline)(Measured at baseline and then following chronic (12 weeks) treatment)
- Social network size (change from baseline)(Measured at baseline and then following chronic (12 weeks) treatment)
- Immune/inflammatory response (change from baseline)(Measured at baseline and then following chronic (12 weeks) treatment)
- Cardiovascular reactivity- Blood pressure (change from baseline)(Measured at baseline and then following chronic (12 weeks) treatment)
- Immune/inflammatory response(change from baseline)(Measured at baseline and then following chronic (12 weeks) treatment)
- General health(change from baseline)(Measured at baseline and then following chronic (12 weeks) treatment)
- Sleep quality (change from baseline)(Measured at baseline and then following chronic (12 weeks) treatment)
- Cardiovascular reactivity- Heart rate (change from baseline)(Measured at baseline and then following chronic (12 weeks) treatment)
- General health (change from baseline)(Measured at baseline and then following chronic (12 weeks) treatment)
- Nutrition Status(Measured at baseline and then following chronic (12 weeks) treatment)
- Daily functioning and care behaviours (change from baseline)(Measured at baseline and then following chronic (12 weeks) treatment)
- Loneliness (change from baseline)(Measured at baseline and then following chronic (12 weeks) treatment)