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Improving Everyday Functioning in Adults Aged 70 and Over Using a Multivitamin Supplement

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04112732
Recruitment Status : Recruiting
First Posted : October 2, 2019
Last Update Posted : May 13, 2020
Sponsor:
Collaborator:
Vitabiotics
Information provided by (Responsible Party):
Northumbria University

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

Condition or disease Intervention/treatment Phase
Aging Stress Dietary Supplement: Multivitamin Other: Placebo Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Other
Official Title: Improving Everyday Functioning in Adults Aged 70 and Over Using a Multivitamin Supplement
Actual Study Start Date : November 24, 2019
Estimated Primary Completion Date : September 1, 2021
Estimated Study Completion Date : September 1, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Multivitamin
1 multivitamin tablet administered by mouth daily for 12 weeks, to be taken with main meal.
Dietary Supplement: Multivitamin
Multivitamin

Placebo Comparator: Placebo
1 placebo tablet administered by mouth daily for 12 weeks, to be taken with main meal.
Other: Placebo
Placebo




Primary Outcome Measures :
  1. Overall Well-Being (change from baseline) [ Time Frame: 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?


Secondary Outcome Measures :
  1. Cardiovascular reactivity- Blood pressure (change from baseline) [ Time Frame: Measured at baseline and then following chronic (12 weeks) treatment ]
    Systolic and Diastolic blood pressure measured via Portapres a non-invasive, continuous beat-to-beat blood pressure monitoring system.

  2. Cardiovascular reactivity- Heart rate (change from baseline) [ Time Frame: Measured at baseline and then following chronic (12 weeks) treatment ]
    Beats per minute, measured via Portapres a non-invasive, continuous beat-to-beat blood pressure monitoring system.

  3. Immune/inflammatory response (change from baseline) [ Time Frame: Measured at baseline and then following chronic (12 weeks) treatment ]
    C-Reactive Protein (CRP)

  4. Immune/inflammatory response(change from baseline) [ Time Frame: Measured at baseline and then following chronic (12 weeks) treatment ]
    Secretory Immunoglobulin-A (s-IgA)

  5. Self-Reported Stress (change from baseline) [ Time Frame: Measured at baseline and then following chronic (12 weeks) treatment ]
    The Kingston Caregiver Stress Scale.This tool is designed to assess levels of perceived stress associated with caregiving in informal carers. The scale comprises three sections that assess levels of stress in relation to care-related feelings; family matters; and financial stresses. Higher scores indicate higher levels of stress

  6. Self-Reported Stress (change from baseline) [ Time Frame: Measured at baseline and then following chronic (12 weeks) treatment ]
    The Perceived Stress Scale (PSS), The PSS is a 10-item scale which measures the extent to which participants perceive their lives to be overwhelming, uncontrollable and unpredictable.Scale responses range from 0 (never) to 4 (very often) and items are summed to yield a total score. Higher scores indicate greater perceived levels of stress, experienced over the previous month

  7. General health(change from baseline) [ Time Frame: Measured at baseline and then following chronic (12 weeks) treatment ]
    Cohen Hoberman Inventory of Physical Symptoms.The CHIPS was designed as a measure of perceived burden due to the experience of a range of physical symptoms. The scale comprises a list of 33 common everyday symptoms (e.g. 'acne', 'diarrhoea', 'heart pounding or racing') and asks respondents 'how much that problem has bothered or distressed you during the past two weeks including today'. Items are scored for 1-5, then summed across all items. Higher scores indicate worse health

  8. General health (change from baseline) [ Time Frame: Measured at baseline and then following chronic (12 weeks) treatment ]
    SF-20. The survey measures health across 6 domains: physical functioning (6 questions), role functioning (2 questions), social functioning (1 question), mental health (5 questions), health perceptions (5 questions), and pain (1 question).Scores across each of these domains are reported on a 0% to 100% scale, with 0% representing the worst possible score in that domain and 100% the best possible score. Raw scores are transformed to fit the 0% to 100% interval as described in the original publication (note that for question #1 on general health, an initial transformation is performed as follows: 1 = 5, 2 = 4.36, 3 = 3.43, 4 = 1.99, 5 = 1). Reversal of scoring is completed as necessary such that the highest score always represents the best possible score. The exception to this scoring pattern is the pain score, for which 0% represents the best possible score and 100% the worst possible score,

  9. Daily functioning and care behaviours (change from baseline) [ Time Frame: Measured at baseline and then following chronic (12 weeks) treatment ]

    Instrumental Activities of Daily Living Scale. is an appropriate instrument to assess independent living skills.There are eight domains of function measured with the Lawton IADL scale.

    Women are scored on all 8 areas of function; historically, for men, the areas of food preparation, housekeeping, laundering are excluded.

    Clients are scored according to their highest level of functioning in that category. A summary score ranges from 0 (low function, dependent) to 8 (high function, independent) for women, and 0 through 5 for men.


  10. Mood trait measures (change from baseline) [ Time Frame: Measured at baseline and then following chronic (12 weeks) treatment ]
    Hospital Anxiety and Depression Scale, this is a 14 item scales, with scale responsed rangin from 0 to 5. Scores are summed to produce separate scores for anxiety and depression. Higher scores indicate more frequent feelings of anxiety and depressive symptoms. Scores between 0 and 7 are considered normal. Scores between 8 and 10 are indicative of borderline mood disorder and scores > 11 indicates probable mood disorder

  11. Mood trait measures (change from baseline) [ Time Frame: Measured at baseline and then following chronic (12 weeks) treatment ]
    Profile of Moods States (POMS). This comprises 37 items with response ranging from 'not at all' to 'extremely'. Scores from the POMS-SF are used to derive a total score for 'mood disturbance', as well as subscores for the domains of 'tension', 'depressed', 'anger', 'vigour', 'fatigue' and 'concentration'. A total score disturbance score can also be calculated by adding the scores from the first five of these global scores and subtracting 'vigour

  12. Acute measures of subjective state in responses to a stressor (change from baseline) [ Time Frame: Measured at baseline and then following chronic (12 weeks) treatment ]
    State-Trait Anxiety Inventory (STAI) The STAI is a widely used instrument consisting of two subscales assessing 'State' and 'Trait' anxiety respectively. Each subscale contains 20 statements (e.g. 'I am calm') each with a 4-point Likert scale, giving a range of potential scores from 20 to 80. Participants rate how much they feel like each statement at the time of making the response (State subscale), and how much they generally feel like each statement (Trait subscale). Higher scores indicate greater anxiety.

  13. Acute measures of subjective state in responses to a stressor (change from baseline) [ Time Frame: Measured at baseline and then following chronic (12 weeks) treatment ]
    NASA-Task Load Index. The NASA-TLX comprises a set of six scales anchored with 'Low' and 'High' at the extreme points. Three of the scales reflect the demand placed upon the respondent by the task (Mental Demand, Physical Demand, Temporal Demand), whereas three reflect the interaction between the respondent and the task (Effort, Perceived Performance, Frustration).

  14. Cognitive function (change from baseline) [ Time Frame: Measured at baseline and then following chronic (12 weeks) treatment ]
    Task performance on the Multi-Tasking Framework (MTF),

  15. Cognitive function (change from baseline) [ Time Frame: Measured at baseline and then following chronic (12 weeks) treatment ]
    Prospective and Retrospective memory Questionnaire, The PRMQ is a 16 item scale that quantifies memory failures for everyday tasks over two subscales: prospective memory (e.g., do you forget appointments if you are not prompted by someone else or by a reminder such as a calendar or diary?) and retrospective memory (e.g., do you fail to do something you were supposed to do a few minutes later even though it's there in front of you, like take a pill or turn off the kettle?). Scale responses range from 1 (never) to 5 (very often), and higher scores indicate poorer everyday memory.

  16. Cognitive function (change from baseline) [ Time Frame: Measured at baseline and then following chronic (12 weeks) treatment ]
    A covert measure of prospective memory, whereby participants will be asked to remember to return a reminder slip with their 'participant number' written on, which will be posted out before testing visits.

  17. Sleep quality (change from baseline) [ Time Frame: Measured at baseline and then following chronic (12 weeks) treatment ]
    Pittsburgh Sleep Quality Index. The PSQI assesses seven factors - subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication and daytime dysfunction - via questions regarding sleep timings and zero to three-point scales in which participants rate whether they have experienced a number of issues (e.g. 'During the past week, how often have you had trouble sleeping because you have had bad dreams?') from 'not during the past week' to '3 or more times in the past week'. A global sleep score is created by totalling the seven subfactor scores, with higher scores indicating poorer sleep quality.

  18. Mobility (change from baseline) [ Time Frame: Measured at baseline and then following chronic (12 weeks) treatment ]
    Yale Physical Activity Scale, The YPAS is an interviewer-administered questionnaire developed to assess physical activity in older adults. The YPAS is divided into two sections: in the first section, there is a comprehensive physical work, exercise, and recreational activities checklist to assess time spent in these types of activities during a typical week in the past month. The second section contains questions to quickly assess an individual's participation in five activity dimensions: vigorous activity, leisurely walking, moving on feet, standing, and sitting. Responses on the YPAS allow eight summary indices to be calculated: total time spent per week in all physical activities, weekly energy expenditure in kcal per week, five individual indices for the activity dimensions, and an activity dimension summary index

  19. Mobility (change from baseline) [ Time Frame: Measured at baseline and then following chronic (12 weeks) treatment ]
    Falls Efficacy Scale, measures of "fear of falling" or, more properly, "concerns about falling.To calculate the FES-I score when all items are completed, simply add the scores for each item together to give a total that ranges from a minimum 16 (no concern about falling) to maximum 64 (severe concern about falling).

  20. Mobility(change from baseline) [ Time Frame: Measured at baseline and then following chronic (12 weeks) treatment ]
    Timed up and Go Test, length of time in seconds it takes participants to stand form a chair, walk 3 metres, turn around and sit back down in chair.

  21. Mobility (change from baseline) [ Time Frame: Measured at baseline and then following chronic (12 weeks) treatment ]
    Grip Strength. 3 trials on non dominant hand. Measured in kg.

  22. Mobility(change from baseline) [ Time Frame: Measured at baseline and then following chronic (12 weeks) treatment ]
    Balance tests. Measured to see if participants can hold 3 stances for 10s. If they can they are awarded 1 point, if not 0 points.

  23. Social network size (change from baseline) [ Time Frame: Measured at baseline and then following chronic (12 weeks) treatment ]
    Lubben Social Network Scale, This measure uses 6 questions: 3 key questions evaluate the size of 3 different aspects of social network that are attributable to family ties and a parallel set attributable to friendship ties. Each LSNS-6 question is scored on a 0 to 5 scale. The total score is an equally weighted sum of these 6 questions, with scores ranging from 0 to 30.

  24. Social network size (change from baseline) [ Time Frame: Measured at baseline and then following chronic (12 weeks) treatment ]
    Convoy Method. • Respondents are presented with a set of three concentric circles, with the word 'You' contained within a smaller circle in the middle. Respondents are asked to think about "people who are important in your life right now, but who are not equally close". Respondents are then asked to think about "people to whom you feel so close it is hard to imagine life without them"; these people are entered into the innermost circle. For the next circle respondents are asked to consider "people to whom you may not feel quite that close but who are still very important to you". Finally, in the outer circle respondents are asked to place "People whom you haven't already mentioned but who are close enough and important enough in your life that they are part of your personal network". The numbers of people within each network are counted and can be used to represent support networks in each of the categories and / or summed to produce an index of total social network size

  25. Loneliness (change from baseline) [ Time Frame: Measured at baseline and then following chronic (12 weeks) treatment ]
    The De Jong Gierveld Loneliness Scale,This tool can be used to provide a single index of loneliness in addition to indices of 'Emotional Loneliness' and 'Social Loneliness' . To score the answers to the scale, the neutral and positive answers are scored as "1" on the negatively worded questions and On the positively worded items, the neutral and negative answers are scored as "1"

  26. Nutrition Status [ Time Frame: Measured at baseline and then following chronic (12 weeks) treatment ]
    Blood biomarkers taken to assess impact of nutritional status, this will measure vitmain B12, ferritin and folate.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04112732


Contacts
Layout table for location contacts
Contact: Sarah Docherty 0191 243 7026 s.docherty@northumbria.ac.uk
Contact: Crystal Haskell-Ramsay, Dr crystal.haskell-ramsay@northumbria.ac.uk

Locations
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United Kingdom
Northumbria University Recruiting
Newcastle Upon Tyne, United Kingdom, NE1 8ST
Contact: Sarah Docherty    0191 243 7026    s.docherty@northumbria.ac.uk   
Sponsors and Collaborators
Northumbria University
Vitabiotics
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Responsible Party: Northumbria University
ClinicalTrials.gov Identifier: NCT04112732    
Other Study ID Numbers: 17016
First Posted: October 2, 2019    Key Record Dates
Last Update Posted: May 13, 2020
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Northumbria University:
Multivitamin
Aging
Stress
Everyday Function
Well-Being