Clinical trial NCT04112732: Improving Everyday Functioning in Adults Aged 70 and Over Using a Multivitamin Supplement
Official title: Improving Everyday Functioning in Adults Aged 70 and Over Using a Multivitamin Supplement
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Aging
Stress
Keywords: Multivitamin
Aging
Stress
Everyday Function
Well-Being
Lead sponsor: Northumbria University
Sponsor class: OTHER
Collaborators: name: Vitabiotics
First posted: 2019-10-02
Enrollment: 300
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Investigation of the chronic effect of 12 week multivitamin supplementation on markers of everyday function in adults aged 70 and over.

Detailed description: 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.

These necessary changes to the method of data collection will be a confounding factor in this group, which would not be comparable to the main dataset. Therefore, the decision has been made to un-blind the researcher to this group of participants' treatment (11 who completed in full prior and 34 who completed testing visit 2 online).

This will allow the main outcome measures to be compared in this unique group of participants', as well as comparisons between outcome measures in those who completed pre and during lockdown.

Eligibility criteria: Inclusion Criteria

* Aged over 70
* Both caregivers and non caregivers will be recrtuied

Exclusion Criteria

* 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

Primary outcomes:
measure: Overall Well-Being (change from baseline)
timeFrame: Measured at baseline and then following chronic (12 weeks) treatment
Secondary outcomes:
measure: Cardiovascular reactivity- Blood pressure (change from baseline)
timeFrame: Measured at baseline and then following chronic (12 weeks) treatment
measure: Cardiovascular reactivity- Heart rate (change from baseline)
timeFrame: Measured at baseline and then following chronic (12 weeks) treatment
measure: Immune/inflammatory response (change from baseline)
timeFrame: Measured at baseline and then following chronic (12 weeks) treatment
measure: Immune/inflammatory response(change from baseline)
timeFrame: Measured at baseline and then following chronic (12 weeks) treatment
measure: Self-Reported Stress (change from baseline)
timeFrame: Measured at baseline and then following chronic (12 weeks) treatment
measure: Self-Reported Stress (change from baseline)
timeFrame: Measured at baseline and then following chronic (12 weeks) treatment
measure: General health(change from baseline)
timeFrame: Measured at baseline and then following chronic (12 weeks) treatment
measure: General health (change from baseline)
timeFrame: Measured at baseline and then following chronic (12 weeks) treatment
measure: Daily functioning and care behaviours (change from baseline)
timeFrame: Measured at baseline and then following chronic (12 weeks) treatment
measure: Mood trait measures (change from baseline)
timeFrame: Measured at baseline and then following chronic (12 weeks) treatment
measure: Mood trait measures (change from baseline)
timeFrame: Measured at baseline and then following chronic (12 weeks) treatment
measure: Acute measures of subjective state in responses to a stressor (change from baseline)
timeFrame: Measured at baseline and then following chronic (12 weeks) treatment
measure: Acute measures of subjective state in responses to a stressor (change from baseline)
timeFrame: Measured at baseline and then following chronic (12 weeks) treatment
measure: Cognitive function (change from baseline)
timeFrame: Measured at baseline and then following chronic (12 weeks) treatment
measure: Cognitive function (change from baseline)
timeFrame: Measured at baseline and then following chronic (12 weeks) treatment
measure: Cognitive function (change from baseline)
timeFrame: Measured at baseline and then following chronic (12 weeks) treatment
measure: Sleep quality (change from baseline)
timeFrame: Measured at baseline and then following chronic (12 weeks) treatment
measure: Mobility (change from baseline)
timeFrame: Measured at baseline and then following chronic (12 weeks) treatment
measure: Mobility (change from baseline)
timeFrame: Measured at baseline and then following chronic (12 weeks) treatment
measure: Mobility(change from baseline)
timeFrame: Measured at baseline and then following chronic (12 weeks) treatment
measure: Mobility (change from baseline)
timeFrame: Measured at baseline and then following chronic (12 weeks) treatment
measure: Mobility(change from baseline)
timeFrame: Measured at baseline and then following chronic (12 weeks) treatment
measure: Social network size (change from baseline)
timeFrame: Measured at baseline and then following chronic (12 weeks) treatment
measure: Social network size (change from baseline)
timeFrame: Measured at baseline and then following chronic (12 weeks) treatment
measure: Loneliness (change from baseline)
timeFrame: Measured at baseline and then following chronic (12 weeks) treatment
measure: Nutrition Status
timeFrame: Measured at baseline and then following chronic (12 weeks) treatment
Other outcomes:
Locations:
city: Newcastle Upon Tyne
country: United Kingdom
facility: Northumbria University
Study officials:
References: