Plain English Summary
Background and study aims
Elderly people may benefit from increased physical and cognitive (mental) fitness through the combination of video-game based physical fitness with omega-3 fatty acids. The aim of this study is to evaluate the effect of physical exercise combined with omega-3 fatty acid supplementation in elderly people.
Who can participate?
People aged over 65, healthy, and living independently or in a community residence.
What does the study involve?
Participants are randomly allocated to one of the two groups. One group receives omega-3 supplements, while the second group receives olive oil supplements. Participants take nutritional supplements for 26 weeks. After 16 weeks, they start with physical exercise three times per week for 30 minutes. Participants undergo brain scans before and after the intervention. Blood samples are taken before the intervention, after 16 weeks, and at the end of the intervention.
What are the possible benefits and risks of participating?
Participants possibly benefit from increased physical and cognitive (mental) fitness through the combination of video-game based physical fitness with omega-3 fatty acids. The risk of falls is not greater than in the normal life of the elderly participants. Special attention is given to minimize the risk of falls while training. The risks of omega-3 fatty acid supplementation are minimal with the given dosage. No other risks or side effects are expected.
Where is the study run from?
Swiss Federal Institute of Technology (Switzerland)
When is the study starting and how long is expected to run for?
November 2015 to December 2016.
Who is funding the study?
Swiss Federal Institute of Technology (Switzerland)
Who is the main contact?
Alexandra Schättin
schaetta@hest.ethz.ch
Trial website
Contact information
Type
Scientific
Primary contact
Dr Eling D de Bruin
ORCID ID
Contact details
ETH Zurich
Institute of Human Movement Sciences and Sport
HCP H
Leopold-Ruzicka-Weg 4
Zurich
CH-8093
Switzerland
Type
Scientific
Additional contact
Ms Alexandra Schättin
ORCID ID
http://orcid.org/0000-0003-2831-3781
Contact details
ETH Zurich
Institute of Human Movement Sciences and Sport
HIT J 32
Wolfgang-Pauli-Strasse 27
Zurich
8093
Switzerland
-
schaetta@hest.ethz.ch
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
The combinatory effect of physical exercise and omega-3 fatty acid supplementation on the neuronal system in the elderly brain: randomized placebo-controlled trial using structural and functional neuronal test methods
Acronym
ENEB
Study hypothesis
1. The combination of physical exercise with omega-3 fatty acid nutritional supplementation is more effective than single physical exercise in contributing to structural level (synaptic plasticity) changes in the elderly brain
2. The combination of physical exercise with omega-3 fatty acid nutritional supplementation is more effective than single physical exercise in contributing to functional level (neuronal activity, neuronal drive, and cognitive functioning) changes in the elderly brain
Ethics approval
1. Canton of Zurich Ethics Committee (Switzerland), 20/10/2015, ref: KEK-ZH-Nr. 2015-0190
2. Swissmedic (Bern, Switzerland), 17/11/2015, ref: 2015DR2173
Study design
Single-centre two-groups pre-test, mid-test (blood sample after 16 weeks), post-test (26 weeks) randomized controlled clinical trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Prevention
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
People over 65 years, healthy (self-report), and living independently or in a community residence
Intervention
Participants are randomized into two groups with different nutritional supplementation:
1. Intervention group: This group will take 13.5 ml of omega-3 fatty acid supplementation daily for 26 weeks at home
2. Control group: This group will take 13.5 ml of olive oil supplementation daily for 26 weeks at home
After 16 weeks, all participants follow 10 weeks of guided video-game-based physical exercise. Training sessions take place three times per week for 30 minutes. For the video-game training, the participant follows the step instructions presented on a computer screen. Participants are standing on a pressure-sensitive platform, which records right and wrong movements. Participants are accustomed slowly to the exercise and are continuously monitored by the instructors.
Intervention type
Mixed
Phase
Drug names
Primary outcome measures
Current primary outcome measures as of 24/02/2016:
1. Structural level:
1.1. Transcranial magnetic stimulation: Motor evoked potential in M.tibialis anterior
2. Functional level:
2.1. Electroencephalography: Event related potential and frequency band distribution
2.2. Cognitive test: Test for Attentional Performance (TAP)
All measures are assessed pre-intervention and after intervention.
Previous primary outcome measures:
1. Structural level:
1.1. Transcranial magnetic stimulation: Motor evoked potential in M.tibialis anterior
2. Functional level:
2.1. Electroencephalography: Event related potential and frequency band distribution
2.2. Cognitive tests: Test for Attentional Performance (TAP) and Attention Network Test (ANT)
All measures are assessed pre-intervention and after intervention.
Secondary outcome measures
1. Gait parameters:
1.1. Temporal and spatial gait parameters are assessed with the Physilog®
2. Prevention of falls:
2.1. Icon Falls Efficacy Scale International (Icon-FES-I) questionnaire is used as a measure of 'concern' about falling, to determine the transfer effects of training to activities of daily living
3. Mental state and depression:
3.1. Mini Mental State Examination (MMSE)
3.2. Geriatric Depression Scale (GDS): symptoms of depression are recorded. The German version of the GDS has a good validity and reliability
4. Blood samples measuring fatty acid
All measures are assessed pre-intervention and after intervention. In addition, blood samples are measured after 16 weeks.
Overall trial start date
20/11/2015
Overall trial end date
31/12/2016
Reason abandoned
Eligibility
Participant inclusion criteria
1. Age above 65 years
2. Live independently or in a residency dwelling
3. Non-smoker
4. Healthy (self-reported)
Participant type
Healthy volunteer
Age group
Senior
Gender
Both
Target number of participants
60
Participant exclusion criteria
1. Mobility or cognitive impairments
2. Orthopaedic or neurological diseases preventing training participation
3. Rapidly progressive or terminal illness, acute or chronic illness
4. History of stroke, epilepsy, or seizure
5. Medication that interacts with nutritional supplementation
6. Medication that acts on a neuronal level
7. Mini Mental Status < 22 points
8. Signs of upcoming depression (GDS)
9. Electronic or metallic head implants
Recruitment start date
01/12/2015
Recruitment end date
30/06/2016
Locations
Countries of recruitment
Switzerland
Trial participating centre
ETH Zurich, Institute of Human Movement Sciences and Sport
8093
Switzerland
Funders
Funder type
University/education
Funder name
Eidgenössische Technische Hochschule Zürich (ETH Research Grant ET-17 13-2)
Alternative name(s)
Federal Institute of Technology Zurich, ETH Zürich, ETH
Funding Body Type
private sector organisation
Funding Body Subtype
academic
Location
Switzerland
Results and Publications
Publication and dissemination plan
We plan to publish the article in a high-impact peer reviewed journal.
IPD sharing statement:
The datasets generated during and/or analysed during the current study are/will be available upon request from Alexandra Schättin, schaetta@ethz.ch
Intention to publish date
30/04/2018
Participant level data
Available on request
Results - basic reporting
See additional file (ISRCTN12084831_BasicResults_13Dec17)
Publication summary
Publication citations
Additional files
- ISRCTN12084831_BasicResults_13Dec17.pdf Uploaded 22/01/2018