Completed

NCT Number: NCT02086409

GAit, MEmory, Dietary and Vitamin D

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.

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Key information

Conditions

Memory Complaint Without Cognitive Decline

Age range

65 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Centre Hospitalier Universitaire d'Angers

Angers, Maine et Loire, 49933, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Yogurt supplemented with vitamin D and calcium

Dietary Supplement

The product is a yogurt containing 200 IU of vitamin D and 400 mg of calcium. Participants take 2 yogurts per day.

Yogurt not supplemented with vitamin D and calcium

Dietary Supplement

The comparator is represented by a yogurt not supplemented with vitamin D and calcium.Participants take 2 yogurts per day.

Primary outcomes

Change in spatiotemporal gait, and in particular in the variability of stride time

Time frame: This outcome is assessed at baseline and 12 weeks after oral intake.

Stride time variability is measured with spatiotemporal analysis of walking

Secondary outcomes

Change in posture

Time frame: 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 grip strength

Time frame: This outcome is assessed at baseline and 12 weeks after oral intake.

Grip strength is measured with a dynamometer.
Change in executive performance

Time frame: 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 other cognitive scores

Time frame: 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
Change in the serum concentration of 25 OHD

Time frame: 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

Time frame: This outcome is assessed 12 weeks after oral intake.

Compliance is measured by the number of yogurt capsules returned

Sponsors and collaborators

Lead sponsor

University Hospital, Angers

Other Gov

Registry information

Official study title

Dairy Product, Calcium & Vitamin D Supplementation and Cognitive-motor Function

Acronym: GAME-D2

Important dates

Study start: 2014
Primary completion: 2015
Study completion: 2015
First posted: Mar 13, 2014
Registry last updated: Sep 22, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.