Condition category
Not Applicable
Date applied
30/11/2015
Date assigned
01/12/2015
Last edited
01/12/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

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

Sponsor information

Organisation

Swiss Federal Institute of Technology Zurich (ETH) (Switzerland)

Sponsor details

Institute of Human Movement Sciences and Sport
HCP H
PD Dr. E.D. de Bruin
Leopold-Ruzicka-Weg 4
Zurich
CH- 8093
Switzerland

Sponsor type

University/education

Website

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

To be confirmed at a later date

Intention to publish date

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

01/12/2016: The study contact address has been updated.