Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-04-05 @ 5:27 PM
Study NCT ID:
NCT07346703
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2026-01-16
First Post:
2025-11-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of DHA in Patients With Multiple Sclerosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009103', 'term': 'Multiple Sclerosis'}], 'ancestors': [{'id': 'D020278', 'term': 'Demyelinating Autoimmune Diseases, CNS'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D003711', 'term': 'Demyelinating Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004281', 'term': 'Docosahexaenoic Acids'}, {'id': 'D019587', 'term': 'Dietary Supplements'}, {'id': 'D000074242', 'term': 'Sunflower Oil'}], 'ancestors': [{'id': 'D015525', 'term': 'Fatty Acids, Omega-3'}, {'id': 'D004042', 'term': 'Dietary Fats, Unsaturated'}, {'id': 'D004041', 'term': 'Dietary Fats'}, {'id': 'D005223', 'term': 'Fats'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D005231', 'term': 'Fatty Acids, Unsaturated'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D005395', 'term': 'Fish Oils'}, {'id': 'D009821', 'term': 'Oils'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}, {'id': 'D010938', 'term': 'Plant Oils'}, {'id': 'D028321', 'term': 'Plant Preparations'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': '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.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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.\n\nAll participants will complete the study. The duration of the intervention will be 3 months.\n\nDHA = docosahexaenoic acid. Placebo = sunflower oil.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-07', 'studyFirstSubmitDate': '2025-11-28', 'studyFirstSubmitQcDate': '2026-01-07', 'lastUpdatePostDateStruct': {'date': '2026-01-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ISOKINETIC', 'timeFrame': 'Throughout study completion, an average of 12 weeks', 'description': 'Measurement of isokinetic strength in the right leg N/m'}], 'secondaryOutcomes': [{'measure': 'Modified Fatigue Impact Scale', 'timeFrame': 'Throughout study completion, an average of 12 weeks', 'description': '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).'}, {'measure': 'MSQoL-54 - Walking Status', 'timeFrame': 'Throughout study completion, an average of 12 weeks', 'description': 'Description: Functional walking status assessed using the walking-related item of the MSQoL-54.\n\nUnit of Measure: Categorical (able to walk without assistance / needs assistance / wheelchair dependent).'}, {'measure': 'MSQoL-54 - Days Unable to Work or Attend School Due to Health', 'timeFrame': 'Throughout study completion, an average of 12 weeks', 'description': 'Description: Number of days participants were unable to work or attend school due to health problems during the previous month, assessed via MSQoL-54.\n\nUnit of Measure: Days (0, 1-15, 16-30).'}, {'measure': 'MSQoL-54 - Hospital Admission in the Previous Year', 'timeFrame': 'Throughout study completion, an average of 12 weeks', 'description': 'Description: Self-reported hospital admission related to health status in the previous year, assessed via MSQoL-54.\n\nUnit of Measure: Binary (yes/no).'}, {'measure': 'MSQoL-54 - Depressive Symptoms', 'timeFrame': 'Throughout study completion, an average of 12 weeks', 'description': 'Description: Presence of self-reported depressive symptoms assessed using the corresponding MSQoL-54 item.\n\nUnit of Measure: Binary (yes/no).'}, {'measure': 'THERMOGRAPHY', 'timeFrame': 'Pre, six weeks after the start and after the intervention (12 weeks)', 'description': '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.'}, {'measure': 'SIT TO STAND TEST', 'timeFrame': 'Throughout study completion, an average of 12 weeks', 'description': '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.'}, {'measure': 'TIME UP AND GO test', 'timeFrame': 'Throughout study completion, an average of 12 weeks', 'description': '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.'}, {'measure': 'HAND GRIP', 'timeFrame': 'Throughout study completion, an average of 12 weeks', 'description': 'Hand grip to assess upper limb strength through pre- and post-treatment grip strength. The unit of measurement is the kilogram.'}, {'measure': 'IL-6', 'timeFrame': 'Pre, six weeks after the start and after the intervention (12 weeks)', 'description': 'Serum interleukin 6 levels will be determined by blood sampling performed by an experienced nurse and analyzed in our reference laboratory.'}, {'measure': 'MSQoL-54 - Multiple Sclerosis Disease Duration', 'timeFrame': 'Baseline', 'description': 'Description: Duration of multiple sclerosis since diagnosis.\n\nUnit of Measure: Years.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Multiple sclerosis', 'Omega-3', 'nutritional supplements'], 'conditions': ['Multiple Sclerosis', 'Performance Enhancement', 'Supplemental Nutrition Assistance Program Education', 'Strength Outcomes', 'Function Improvement', 'Intervention Study']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://investigacion.ucam.edu/vicerrectorado/ciard', 'label': 'Research Center for High Performance Sport. Universidad Católica de Murcia.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'Design\n\nRandomized clinical trial.\n\nStudy Period\n\nTwo years: from January 2024 to January 2026.\n\nPopulation Selection Reference Population\n\nThe 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.\n\nEligible 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.\n\nSample Size\n\nGiven 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.\n\nParticipants will be randomly assigned to one of four groups, each following a different therapeutic protocol:\n\nGroup 1: therapeutic exercise protocol three times per week throughout the study + daily DHA supplementation (4 capsule/day).\n\nGroup 2: same exercise protocol + placebo capsule (sunflower oil) identical in appearance, color, and dosage.\n\nGroup 3: DHA supplementation only (4 capsule/day).\n\nGroup 4: placebo capsule only (sunflower oil), identical to intervention groups.\n\nStatistical Design\n\nA one-way or repeated-measures ANOVA will be used to test for statistically significant differences among three or more dependent samples.\n\nMeasurement time points will be defined as follows:\n\nT0: baseline (pre-intervention).\n\nT1: midpoint of the intervention (approximately 1.5 months after initiation).\n\nT2: immediately after completing the 3-month intervention protocol.\n\nT3: 3 months after the end of the intervention.\n\nData Collection Participant Characteristics\n\nSensitive data will be collected regarding:\n\nAge, sex, height, weight, medication use, relapse episodes in the months prior to the study, disability status, disease condition, and cognitive function.\n\nAdditional psychophysical information will be gathered using validated questionnaires administered before and after the intervention:\n\nDisability will be assessed using the Expanded Disability Status Scale (EDSS).\n\nA score of 0.0 represents normal physical function without disability.\n\n3-4 indicates mild impairment not limiting daily or work activities.\n\n5-6 indicates moderate disability, typically able to walk but requiring assistance for about 100 meters at level 6.\n\n7-9 represents severe impairment, often confined to a wheelchair or bed.\n\nCognitive 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).\n\nFatigue 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.\n\nQuality 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.\n\nFunctional Assessments\n\nPre, during and post--intervention.\n\nInfrared 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:\n\nPre and post--intervention.\n\nThe 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.\n\nThe 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.\n\nThe 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).\n\nThe 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.\n\nHandgrip strength will be measured (pre- and post-intervention) to assess upper-limb muscle strength.\n\nIsokinetic strength tests will evaluate lower-limb strength (pre- and post-intervention).\n\nLaboratory Tests\n\nSerum analyses will include measurement of interleukin-6,\n\nBlood samples will be collected at four time points:\n\nPre, during and immediately post-intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nThe 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.\n\nExclusion Criteria:\n\n* Not fulfilling the inclusion criteria.\n* Having any problems performing the tests.\n* Having any problems taking the supplement or placebo.'}, 'identificationModule': {'nctId': 'NCT07346703', 'acronym': 'DHAME', 'briefTitle': 'Effects of DHA in Patients With Multiple Sclerosis', 'organization': {'class': 'OTHER', 'fullName': 'Universidad Católica San Antonio de Murcia'}, 'officialTitle': 'Effects of Therapeutic Exercise and Long-term Docosahexaenoic Acid (DHA) Supplementation on Physical, Physiological, Motor, Mental, and Cognitive Variables in Patients With Multiple Sclerosis.', 'orgStudyIdInfo': {'id': 'CE072415'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'DHA', 'description': 'This group will take 2 g of DHA (4 capsules per day) for 3 months', 'interventionNames': ['Dietary Supplement: Docosahexaenoic Acid (DHA) Dietary Supplement']}, {'type': 'EXPERIMENTAL', 'label': 'DHA + therapeutic exercise', 'description': 'This group will take 2 g of DHA (4 capsules per day) + therapeutic exercise for 3 months', 'interventionNames': ['Dietary Supplement: Docosahexaenoic Acid (DHA) Dietary Supplement']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Sunflower oil', 'description': 'This group will take a placebo (4 capsules per day) for 3 months.', 'interventionNames': ['Dietary Supplement: Sunflower Oil']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Sunflower oil + therapeutic exercise', 'description': 'This group will take a placebo (4 capsules per day) + therapeutic exercise for 3 months.', 'interventionNames': ['Dietary Supplement: Sunflower Oil']}], 'interventions': [{'name': 'Docosahexaenoic Acid (DHA) Dietary Supplement', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Omega-3'], 'description': 'Subjects will take 2 g of DHA per day for 3 months.', 'armGroupLabels': ['DHA']}, {'name': 'Docosahexaenoic Acid (DHA) Dietary Supplement', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Subjects will take 2 g of DHA per day + therapeutic exercise (3 times a week) for 3 months.', 'armGroupLabels': ['DHA + therapeutic exercise']}, {'name': 'Sunflower Oil', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Placebo'], 'description': 'Subjects will take 2 g of placebo (sunflower oil) per day for 3 months.', 'armGroupLabels': ['Sunflower oil']}, {'name': 'Sunflower Oil', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Subjects will take 2 g of placebo per day + therapeutic exercise (3 times a week) for 3 months.', 'armGroupLabels': ['Sunflower oil + therapeutic exercise']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30830', 'city': 'La Ñora', 'state': 'Murcia', 'country': 'Spain', 'facility': 'Research Center for High Performance Sport. Universidad Católica de Murcia', 'geoPoint': {'lat': 37.99031, 'lon': -1.19738}}], 'overallOfficials': [{'name': 'Francisco Javier Martínez Noguera, Researcher-PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Universidad Católica San Antonio de Murcia'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Francisco Javier Martínez Noguera', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Associate Researcher (Doctor of Sports Nutrition)', 'investigatorFullName': 'Francisco Javier Martínez Noguera', 'investigatorAffiliation': 'Universidad Católica San Antonio de Murcia'}}}}