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Multiple SclerosisDHAMENCT07346703

Effects of DHA in Patients With Multiple Sclerosis

A study testing Docosahexaenoic Acid (DHA) Dietary Supplement and Sunflower Oil in people with Multiple Sclerosis and Performance Enhancement, run by Francisco Javier Martínez Noguera at 1 site in Spain.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial summary

This clinical trial will investigate the effects of combining therapeutic exercise with DHA supplementation in 100 patients with multiple sclerosis using a randomized controlled design. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
What is being tested?
Docosahexaenoic Acid (DHA) Dietary Supplement and Sunflower Oil
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
100 participants
Where
1 siteSpain
Study dates
Jan 2026to Jul 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • The patient sample comes from the Multiple Sclerosis Association (AMDEM) of the Murcia region and the neurology department of the Ribera Salud Hospital in Molina de Segura. Patients diagnosed with multiple sclerosis according to the McDonald criteria, aged between 18 and 65 (approximately), who have not suffered any flare-ups in the previous month and who have a score of 0.00 to 6 on the Expanded Disability Status Scale (EDSS) and are able to activate the tibialis anterior muscle will be eligible for the study.

Who cannot join

  • Not fulfilling the inclusion criteria.
  • Having any problems performing the tests.
  • Having any problems taking the supplement or placebo.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Spain1 site
  • Research Center for High Performance Sport. Universidad Católica de Murcia

    La Ñora, Murcia, 30830

Other trials in Spain

About this study

Official title: Effects of Therapeutic Exercise and Long-term Docosahexaenoic Acid (DHA) Supplementation on Physical, Physiological, Motor, Mental, and Cognitive Variables in Patients With Multiple Sclerosis.

This clinical trial will investigate the effects of combining therapeutic exercise with DHA supplementation in 100 patients with multiple sclerosis using a randomized controlled design. Participants, diagnosed according to the McDonald criteria, will undergo functional, cognitive, fatigue, and quality-of-life assessments through tools such as the EDSS, BRB-N, MFIS, EVA-f, and MSQoL-54. Physiological evaluations will include infrared thermography, isokinetic strength testing, perceived exertion (Modified Borg Scale), balance (Timed Up and Go), lower-limb power (Sit-to-Stand app), and handgrip strength. The study hypothesizes that this combined intervention will improve motor function, cognition, fatigue management, and overall quality of life by enhancing neuromuscular activation and metabolic efficiency.

Read the detailed description

Design

Randomized clinical trial.

Study Period

Two years: from January 2024 to January 2026.

Population Selection Reference Population

The study sample will be recruited from the Multiple Sclerosis Association (AMDEM) in the Region of Murcia and the Neurology Department of Hospital Ribera Salud in Molina de Segura.

Eligible participants will be patients diagnosed with multiple sclerosis (MS) according to the McDonald criteria, aged approximately 18 to 65 years, who have not experienced relapse episodes in the month prior to inclusion, and have an Expanded Disability Status Scale (EDSS) score between 0.0 and 6.0, as well as the ability to voluntarily activate the tibialis anterior muscle.

Sample Size

Given the characteristics of the study, the target sample size is at least 100 participants, divided into four groups (n ≈ 25 per group) according to treatment.

Participants will be randomly assigned to one of four groups, each following a different therapeutic protocol:

Group 1: therapeutic exercise protocol three times per week throughout the study + daily DHA supplementation (4 capsule/day).

Group 2: same exercise protocol + placebo capsule (sunflower oil) identical in appearance, color, and dosage.

Group 3: DHA supplementation only (4 capsule/day).

Group 4: placebo capsule only (sunflower oil), identical to intervention groups.

Statistical Design

A one-way or repeated-measures ANOVA will be used to test for statistically significant differences among three or more dependent samples.

Measurement time points will be defined as follows:

T0: baseline (pre-intervention).

T1: midpoint of the intervention (approximately 1.5 months after initiation).

T2: immediately after completing the 3-month intervention protocol.

T3: 3 months after the end of the intervention.

Data Collection Participant Characteristics

Sensitive data will be collected regarding:

Age, sex, height, weight, medication use, relapse episodes in the months prior to the study, disability status, disease condition, and cognitive function.

Additional psychophysical information will be gathered using validated questionnaires administered before and after the intervention:

Disability will be assessed using the Expanded Disability Status Scale (EDSS).

A score of 0.0 represents normal physical function without disability.

3-4 indicates mild impairment not limiting daily or work activities.

5-6 indicates moderate disability, typically able to walk but requiring assistance for about 100 meters at level 6.

7-9 represents severe impairment, often confined to a wheelchair or bed.

Cognitive function will be assessed using the Brief Repeatable Battery of Neuropsychological Tests (BRB-N), a validated tool for MS. It includes tests of selective recall, the 7/24 spatial recall test, the controlled oral word association test, and the paced auditory serial addition test (PASAT).

Fatigue will be measured using the Modified Fatigue Impact Scale (MFIS), assessing the perceived impact of fatigue on cognitive (10 items), physical (10 items), and psychosocial (20 items) functioning. Responses range from 0 (no problem) to 4 (extreme problem), with a maximum score of 160.

Quality of life will be measured with the Multiple Sclerosis Quality of Life-54 (MSQoL-54), a validated MS-specific scale that evaluates symptom severity, walking ability, absenteeism due to health, hospitalization history, depressive symptoms, and disease duration.

Functional Assessments

Pre, during and post--intervention.

Infrared thermography will capture whole-body thermal images before, during, and after the intervention as a non-invasive, reliable, and cost-effective diagnostic tool. Measurements will be taken:

Pre and post--intervention.

The Modified Borg Scale will be used to adjust exercise load intensity, maintaining perceived exertion between 5-7. If the score falls below 5, resistance will be increased by adding up to 5 kg. This will be recorded in the final session of each week.

The EVA-f scale (adapted fatigue visual analogue scale) will be used to measure subjective fatigue perception (0 = no fatigue; 10 = extreme fatigue) at the end of each training session.

The Sit-to-Stand App Test will be used to assess lower-limb power through video-based analysis of standing-up movements, providing values for time, power, and velocity (pre- and post-protocol).

The Timed Up and Go (TUG) Test will assess balance and fall risk. Participants will stand up from a chair, walk 3 meters, turn around, return, and sit down again. Two repetitions per session will be performed with one-minute rest intervals.

Handgrip strength will be measured (pre- and post-intervention) to assess upper-limb muscle strength.

Isokinetic strength tests will evaluate lower-limb strength (pre- and post-intervention).

Laboratory Tests

Serum analyses will include measurement of interleukin-6,

Blood samples will be collected at four time points:

Pre, during and immediately post-intervention.

Being tested
Docosahexaenoic Acid (DHA) Dietary Supplement, Sunflower Oil
Keywords
Multiple sclerosis, Omega-3, nutritional supplements
Medical subject headings
Multiple Sclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Docosahexaenoic Acid (DHA) Dietary SupplementDietary supplement

    Also called Omega-3

    Subjects will take 2 g of DHA per day for 3 months.

  • Docosahexaenoic Acid (DHA) Dietary SupplementDietary supplement

    Subjects will take 2 g of DHA per day + therapeutic exercise (3 times a week) for 3 months.

  • Sunflower OilDietary supplement

    Also called Placebo

    Subjects will take 2 g of placebo (sunflower oil) per day for 3 months.

  • Sunflower OilDietary supplement

    Subjects will take 2 g of placebo per day + therapeutic exercise (3 times a week) for 3 months.

Study groups in NCT07346703
Study groupRoleWhat they receive
DHAExperimentalThis group will take 2 g of DHA (4 capsules per day) for 3 months
Receives: Dietary Supplement: Docosahexaenoic Acid (DHA) Dietary Supplement
DHA + therapeutic exerciseExperimentalThis group will take 2 g of DHA (4 capsules per day) + therapeutic exercise for 3 months
Receives: Dietary Supplement: Docosahexaenoic Acid (DHA) Dietary Supplement
Sunflower oilPlacebo comparatorThis group will take a placebo (4 capsules per day) for 3 months.
Receives: Dietary Supplement: Sunflower Oil
Sunflower oil + therapeutic exercisePlacebo comparatorThis group will take a placebo (4 capsules per day) + therapeutic exercise for 3 months.
Receives: Dietary Supplement: Sunflower Oil

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. ISOKINETIC

    Measurement of isokinetic strength in the right leg N/m

    Measured: Throughout study completion, an average of 12 weeks

Secondary outcomes (11)
  1. Modified Fatigue Impact Scale

    Fatigue is assessed using the Modified Fatigue Impact Scale, which considers the perceived impact of fatigue on cognitive functioning (10 items), physical functioning (10 items) and psychosocial functioning (20 items). It is a self-administered instrument in which subjects are asked to rate the extent to which fatigue has caused them problems (0 = no problem to 4 = extreme problem, maximum score = 160).

    Measured: Throughout study completion, an average of 12 weeks

  2. MSQoL-54 - Walking Status

    Description: Functional walking status assessed using the walking-related item of the MSQoL-54.

    Unit of Measure: Categorical (able to walk without assistance / needs assistance / wheelchair dependent).

    Measured: Throughout study completion, an average of 12 weeks

  3. MSQoL-54 - Days Unable to Work or Attend School Due to Health

    Description: Number of days participants were unable to work or attend school due to health problems during the previous month, assessed via MSQoL-54.

    Unit of Measure: Days (0, 1-15, 16-30).

    Measured: Throughout study completion, an average of 12 weeks

  4. MSQoL-54 - Hospital Admission in the Previous Year

    Description: Self-reported hospital admission related to health status in the previous year, assessed via MSQoL-54.

    Unit of Measure: Binary (yes/no).

    Measured: Throughout study completion, an average of 12 weeks

  5. MSQoL-54 - Depressive Symptoms

    Description: Presence of self-reported depressive symptoms assessed using the corresponding MSQoL-54 item.

    Unit of Measure: Binary (yes/no).

    Measured: Throughout study completion, an average of 12 weeks

  6. THERMOGRAPHY

    Thermography study to capture full-body thermal images will be performed using a Flir E75 camera. The temperature (°C) of the lower limbs will be evaluated by analyzing the images.

    Measured: Pre, six weeks after the start and after the intervention (12 weeks)

  7. SIT TO STAND TEST

    The Sit to Stand app test will be performed and muscle power will be assessed using the application. This tool is based on video recording of the movement of getting up from a chair. The unit of measurement is meters/seconds.

    Measured: Throughout study completion, an average of 12 weeks

  8. TIME UP AND GO test

    The Time Up and Go test will be implemented, which is a method of assessing balance ability consisting of several parts, where the patient starts sitting in a chair, then stands up and walks 3 metres, turns around to return to the chair and then sits down, measuring the time it takes to complete the task. Each measurement will be repeated twice with a one-minute rest in between. To perform this test, the patient needs good posture control, coordination and strength in the lower limbs, and balance, movement control and risk of falls are assessed. The unit of measurement is in seconds.

    Measured: Throughout study completion, an average of 12 weeks

  9. HAND GRIP

    Hand grip to assess upper limb strength through pre- and post-treatment grip strength. The unit of measurement is the kilogram.

    Measured: Throughout study completion, an average of 12 weeks

  10. IL-6

    Serum interleukin 6 levels will be determined by blood sampling performed by an experienced nurse and analyzed in our reference laboratory.

    Measured: Pre, six weeks after the start and after the intervention (12 weeks)

  11. MSQoL-54 - Multiple Sclerosis Disease Duration

    Description: Duration of multiple sclerosis since diagnosis.

    Unit of Measure: Years.

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jan 2026
  2. Study startJan 2026 (estimated)
  3. Primary completionJun 2026 (estimated)
  4. Study completionJul 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
A randomized parallel study will be conducted in which 100 participants with multiple sclerosis will be divided into four groups: one group will take 2 g of DHA (4 capsules; n = 25), another group will take 2 g of DHA (4 capsules; n = 25) combined with therapeutic exercise, a third group will take placebo (4 capsules; n = 25), and a fourth group will take placebo (4 capsules; n = 25) combined with therapeutic exercise. All participants will complete the study. The duration of the intervention will be 3 months. DHA = docosahexaenoic acid. Placebo = sunflower oil.
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07346703
Sponsor's protocol ID
CE072415
Acronym
DHAME
Status last verified
Dec 2025
First submitted
28 Nov 2025
Last updated
16 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Docosahexaenoic Acid (DHA) Dietary Supplement and Sunflower Oil in people with Multiple Sclerosis and Performance Enhancement, run by Francisco Javier Martínez Noguera at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 16 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ISOKINETIC (time frame: Throughout study completion, an average of 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2026.

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