Effects of DHA in Patients With Multiple Sclerosis

NCT07346703 | Enrolling By Invitation

• 1 other identifier: CE072415
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Multiple Sclerosis; Performance Enhancement; Supplemental Nutrition Assistance Program Education; Strength Outcomes; Function Improvement; Intervention Study

Keywords

Multiple sclerosis; Omega-3; nutritional supplements

Outcome Measures

Primary Outcomes (1)

• ISOKINETIC

  Measurement of isokinetic strength in the right leg N/m

  Throughout study completion, an average of 12 weeks

Secondary Outcomes (11)

• Modified Fatigue Impact Scale

  Throughout study completion, an average of 12 weeks

• MSQoL-54 - Walking Status

  Throughout study completion, an average of 12 weeks

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

  Throughout study completion, an average of 12 weeks

• MSQoL-54 - Hospital Admission in the Previous Year

  Throughout study completion, an average of 12 weeks

• MSQoL-54 - Depressive Symptoms

  Throughout study completion, an average of 12 weeks

Study Arms (4)

DHA

EXPERIMENTAL

This group will take 2 g of DHA (4 capsules per day) for 3 months

Dietary Supplement: Docosahexaenoic Acid (DHA) Dietary Supplement

DHA + therapeutic exercise

EXPERIMENTAL

This group will take 2 g of DHA (4 capsules per day) + therapeutic exercise for 3 months

Dietary Supplement: Docosahexaenoic Acid (DHA) Dietary Supplement

Sunflower oil

PLACEBO COMPARATOR

This group will take a placebo (4 capsules per day) for 3 months.

Dietary Supplement: Sunflower Oil

Sunflower oil + therapeutic exercise

PLACEBO COMPARATOR

This group will take a placebo (4 capsules per day) + therapeutic exercise for 3 months.

Dietary Supplement: Sunflower Oil

Interventions

Docosahexaenoic Acid (DHA) Dietary Supplement DIETARY_SUPPLEMENT

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

Also known as: Omega-3

DHA

Sunflower Oil DIETARY_SUPPLEMENT

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

Also known as: Placebo

Sunflower oil

Eligibility Criteria

• Age: 18 Years - 65 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Having any problems performing the tests.
• Having any problems taking the supplement or placebo.

Sponsors & Collaborators

• Francisco Javier Martínez Noguera: lead

Study Sites (1)

Research Center for High Performance Sport. Universidad Católica de Murcia

La Ñora, Murcia, 30830, Spain

Location

Related Links

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

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Docosahexaenoic Acids; Dietary Supplements; Sunflower Oil

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Fatty Acids, Omega-3; Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Plant Oils; Plant Preparations; Biological Products; Complex Mixtures

Study Officials

• Francisco Javier Martínez Noguera, Researcher-PhD

  Universidad Católica San Antonio de Murcia

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The company that formulated the Omega-3 and placebo carried out the randomization, so no one on the research team or among the sponsors knew which group each study subject belonged to. The results of the randomization were sent to our laboratory after the study was completed to determine which subjects were in each group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Researcher (Doctor of Sports Nutrition)

Model Details: 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.

Study Record Dates

• First Submitted: November 28, 2025
• First Posted: January 16, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: January 16, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)