Memory Complaint Without Cognitive Decline
Conditions
Brief summary
Gait and posture disorders are very common in subjects aged 65 and over, and result mainly from neuromuscular and cognitive disorders. Many studies have shown that 1) vitamin D deficiency is very common in women aged 65 and over, 2) individuals with hypovitaminosis D have lower muscle, gait and executive performances and are more prone to fail than individuals with no hypovitaminosis D, 3) the intake of vitamin D combined or not with calcium may improve muscle strength and cognitive performance. The investigators hypothesized that the daily intake of 2 yogurts containing 200 IU of vitamin D and 400 mg of calcium 1) can improve spatiotemporal gait parameters, posture and executive performance, 2) and that this improvement depends of the initial level of vitamin D deficiency.
Interventions
DIETARY_SUPPLEMENTYogurt supplemented with vitamin D and calcium
The product is a yogurt containing 200 IU of vitamin D and 400 mg of calcium. Participants take 2 yogurts per day.
DIETARY_SUPPLEMENTYogurt not supplemented with vitamin D and calcium
The comparator is represented by a yogurt not supplemented with vitamin D and calcium.Participants take 2 yogurts per day.
Sponsors
University Hospital, Angers
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
FEMALE
Age
65 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Woman aged 65 and over * To have hypovitaminosis D (i.e. serum 25-hydroxyvitamin D \[25OHD\] concentration ≤ 30ng/mL) * To have no hypercalcemia (defined as serum calcium concentration ≥ 2,65mmol/L) * Ability to walk a distance of 15 meters unaided * Ability to eat 2 yogurts per day * Memory complaint without cognitive decline * To have given and signed an informed consent to participate in the trial * To be affiliated to French Social Security * To have no vitamin D supplementation during inclusion
Exclusion criteria
* Existence of dementia according to DSM-IV and NINCDS-ADRDA criteria and others cognitive disorders: untreated thyroid dysfunction, chronic ongoing ethylism, history of syphilis, stroke with sequelae, depressive symptomatology (Geriatric Depression Scale \> 5/15) * Osteoarticular diseases of the lower members and / or spine altering the biomechanical characteristics of the body. * Vitamin D supplementation during inclusion * Contraindications to vitamin D * Unstable medical condition * Dairy allergy * Taste of dairy products not supported * Enrolment in another simultaneous clinical trial * Civil defense measures underway * Refusal to participate of the subject
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in spatiotemporal gait, and in particular in the variability of stride time | This outcome is assessed at baseline and 12 weeks after oral intake. | Stride time variability is measured with spatiotemporal analysis of walking |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in grip strength | This outcome is assessed at baseline and 12 weeks after oral intake. | Grip strength is measured with a dynamometer. |
| Change in executive performance | This outcome is assessed at baseline and 12 weeks after oral intake. | Executive performance is measured with Trial Making Test part B (TMT B) |
| Change in posture | This outcome is assessed at baseline and 12 weeks after oral intake. | Posture is evaluated with Time Up & Go, Five Time Sit-to-Stand and posture analysis with a platform. |
| Change in the serum concentration of 25 OHD | This outcome is assessed at baseline and 12 weeks after oral intake. | This outcome is assessed with the serum concentrations of 25OHD |
| Compliance to intervention | This outcome is assessed 12 weeks after oral intake. | Compliance is measured by the number of yogurt capsules returned |
| Change in other cognitive scores | These outcomes are assessed at baseline and 12 weeks after oral intake. | Executive scores are assessed with digit span test (forward and backward), Trial Making Test part A (TMT A), Stoop test and Processing Speed Index |
Countries
France
Outcome results
None listed