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

Primary Purpose

Memory Complaint Without Cognitive Decline

Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Yogurt supplemented with vitamin D and calcium
Yogurt not supplemented with vitamin D and calcium
Sponsored by
University Hospital, Angers
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Memory Complaint Without Cognitive Decline

Eligibility Criteria

65 Years - undefined (Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Centre Hospitalier Universitaire d'Angers

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Yogurt supplemented with vitamin D and calcium

Yogurt not supplemented with vitamin D and calcium

Arm Description

20 participants take yogurt supplemented with vitamin D and calcium during 12 weeks

20 participants take yogurt not supplemented with vitamin D and calcium during 12 weeks

Outcomes

Primary Outcome Measures

Change in spatiotemporal gait, and in particular in the variability of stride time
Stride time variability is measured with spatiotemporal analysis of walking

Secondary Outcome Measures

Change in posture
Posture is evaluated with Time Up & Go, Five Time Sit-to-Stand and posture analysis with a platform.
Change in grip strength
Grip strength is measured with a dynamometer.
Change in executive performance
Executive performance is measured with Trial Making Test part B (TMT B)
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
Change in the serum concentration of 25 OHD
This outcome is assessed with the serum concentrations of 25OHD
Compliance to intervention
Compliance is measured by the number of yogurt capsules returned

Full Information

First Posted
March 11, 2014
Last Updated
September 21, 2016
Sponsor
University Hospital, Angers
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1. Study Identification

Unique Protocol Identification Number
NCT02086409
Brief Title
GAit, MEmory, Dietary and Vitamin D
Acronym
GAME-D2
Official Title
Dairy Product, Calcium & Vitamin D Supplementation and Cognitive-motor Function
Study Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
April 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Angers

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Memory Complaint Without Cognitive Decline

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Yogurt supplemented with vitamin D and calcium
Arm Type
Experimental
Arm Description
20 participants take yogurt supplemented with vitamin D and calcium during 12 weeks
Arm Title
Yogurt not supplemented with vitamin D and calcium
Arm Type
Active Comparator
Arm Description
20 participants take yogurt not supplemented with vitamin D and calcium during 12 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Yogurt supplemented with vitamin D and calcium
Intervention Description
The product is a yogurt containing 200 IU of vitamin D and 400 mg of calcium. Participants take 2 yogurts per day.
Intervention Type
Dietary Supplement
Intervention Name(s)
Yogurt not supplemented with vitamin D and calcium
Intervention Description
The comparator is represented by a yogurt not supplemented with vitamin D and calcium.Participants take 2 yogurts per day.
Primary Outcome Measure Information:
Title
Change in spatiotemporal gait, and in particular in the variability of stride time
Description
Stride time variability is measured with spatiotemporal analysis of walking
Time Frame
This outcome is assessed at baseline and 12 weeks after oral intake.
Secondary Outcome Measure Information:
Title
Change in posture
Description
Posture is evaluated with Time Up & Go, Five Time Sit-to-Stand and posture analysis with a platform.
Time Frame
This outcome is assessed at baseline and 12 weeks after oral intake.
Title
Change in grip strength
Description
Grip strength is measured with a dynamometer.
Time Frame
This outcome is assessed at baseline and 12 weeks after oral intake.
Title
Change in executive performance
Description
Executive performance is measured with Trial Making Test part B (TMT B)
Time Frame
This outcome is assessed at baseline and 12 weeks after oral intake.
Title
Change in other cognitive scores
Description
Executive scores are assessed with digit span test (forward and backward), Trial Making Test part A (TMT A), Stoop test and Processing Speed Index
Time Frame
These outcomes are assessed at baseline and 12 weeks after oral intake.
Title
Change in the serum concentration of 25 OHD
Description
This outcome is assessed with the serum concentrations of 25OHD
Time Frame
This outcome is assessed at baseline and 12 weeks after oral intake.
Title
Compliance to intervention
Description
Compliance is measured by the number of yogurt capsules returned
Time Frame
This outcome is assessed 12 weeks after oral intake.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Centre Hospitalier Universitaire d'Angers
City
Angers
State/Province
Maine et Loire
ZIP/Postal Code
49933
Country
France

12. IPD Sharing Statement

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GAit, MEmory, Dietary and Vitamin D

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