GAit, MEmory, Dietary and Vitamin D (GAME-D2)

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

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.

Study Overview

• Status: Completed
• Conditions: Memory Complaint Without Cognitive Decline
• Intervention / Treatment: Dietary supplement: Yogurt supplemented with vitamin D and calcium; Dietary supplement: Yogurt not supplemented with vitamin D and calcium

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• France
  • Maine et Loire
    • Angers, Maine et Loire, France, 49933
      • Centre hospitalier universitaire d'Angers

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Yogurt supplemented with vitamin D and calcium; 20 participants take yogurt supplemented with vitamin D and calcium during 12 weeks	Dietary supplement: Yogurt 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.
Active Comparator: Yogurt not supplemented with vitamin D and calcium; 20 participants take yogurt not supplemented with vitamin D and calcium during 12 weeks	Dietary supplement: Yogurt 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in spatiotemporal gait, and in particular in the variability of stride time	Stride time variability is measured with spatiotemporal analysis of walking	This outcome is assessed at baseline and 12 weeks after oral intake.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in posture	Posture is evaluated with Time Up & Go, Five Time Sit-to-Stand and posture analysis with a platform.	This outcome is assessed at baseline and 12 weeks after oral intake.
Change in grip strength	Grip strength is measured with a dynamometer.	This outcome is assessed at baseline and 12 weeks after oral intake.
Change in executive performance	Executive performance is measured with Trial Making Test part B (TMT B)	This outcome is assessed at baseline and 12 weeks after oral intake.
Change in other cognitive scores	Executive scores are assessed with digit span test (forward and backward), Trial Making Test part A (TMT A), Stoop test and Processing Speed Index	These outcomes are assessed at baseline and 12 weeks after oral intake.
Change in the serum concentration of 25 OHD	This outcome is assessed with the serum concentrations of 25OHD	This outcome is assessed at baseline and 12 weeks after oral intake.
Compliance to intervention	Compliance is measured by the number of yogurt capsules returned	This outcome is assessed 12 weeks after oral intake.

Collaborators and Investigators

• Sponsor: University Hospital, Angers

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Actual): April 1, 2015
• Study Completion (Actual): April 1, 2015

Study Registration Dates

• First Submitted: March 11, 2014
• First Submitted That Met QC Criteria: March 12, 2014
• First Posted (Estimate): March 13, 2014

Study Record Updates

• Last Update Posted (Estimate): September 22, 2016
• Last Update Submitted That Met QC Criteria: September 21, 2016
• Last Verified: March 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction; Physiological Effects of Drugs; Micronutrients; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Vitamin D; Cholecalciferol; Calcium; Vitamins; Calcium, Dietary; Ergocalciferols
• Other Study ID Numbers: 2013-A01499-36