Multiple Sclerosis Clinical Trial
Official title:
A Randomized, Controlled Trial of Low-fat Diet for Fatigue in Multiple Sclerosis
A randomized, controlled pilot trial of a dietary intervention vs. wait-list control in patients with MS and fatigue for management of their fatigue. The hypothesis of this study is that participants following the low-fat study diet will demonstrate a significant reduction in fatigue after four months compared to wait list controls.
Status | Recruiting |
Enrollment | 108 |
Est. completion date | March 31, 2022 |
Est. primary completion date | September 30, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | For participants with MS: Inclusion Criteria: - Age 18-70 - Diagnosis of MS by 2010 McDonald Criteria - EDSS = 7.5 - Experiencing moderate to severe fatigue (MFIS = 38) Exclusion Criteria: - Current cardiopulmonary disease requiring treatment - Diabetes - Pregnancy or breast-feeding - MS exacerbation within 30 days of screening visit - IV steroids within 30 days of screening visit - Dietary fat content of <30% as assessed by food frequency questionnaire (FFQ) at screening visit - Fish oil or flax seed oil supplementation within 30 days of screening visit |
Country | Name | City | State |
---|---|---|---|
United States | Oregon Health Science University | Portland | Oregon |
Lead Sponsor | Collaborator |
---|---|
Oregon Health and Science University | National Multiple Sclerosis Society |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Microbiome- Relative abundance of targeted species of gut microflora | Measured by 16S rRNA sequencing | Baseline to month 4 | |
Primary | Fatigue | Measured by Modified Fatigue Impact Scale (MFIS). The MFIS is a 21-item questionnaire that assesses overall self-reported fatigue. Subjects rate agreement with a series of statements on a scale of 0 (rarely) to 4 (almost always), in context of their fatigue over the preceding four weeks. Total possible score of 84. Individuals with an MFIS score of > 38 are considered to experience moderate to severe "fatigue | Baseline to month 4 | |
Secondary | Fatigue | Measured by Fatigue Severity Scale (FSS). The FSS is a 9-item questionnaire, with subjects giving a response from 1-7 to indicate their degree of agreement with each statement. | Baseline to month 4 | |
Secondary | Disability | Measured by EDSS. The EDSS is an eight functional system scale including motor, sensory, cerebellar, brain stem, visual, mental, sphincteric, and other systems. Each functional system is graded from 0 (no disability) to 5 or 6 (maximal disability)20. An integrated score between 0 (normal examination) and 10 (death from MS) is formed based on the score in each functional system. | Baseline to month 4 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05528666 -
Risk Perception in Multiple Sclerosis
|
||
Completed |
NCT03608527 -
Adaptive Plasticity Following Rehabilitation in Multiple Sclerosis
|
N/A | |
Recruiting |
NCT05532943 -
Evaluate the Safety and Efficacy of Allogeneic Umbilical Cord Mesenchymal Stem Cells in Patients With Multiple Sclerosis
|
Phase 1/Phase 2 | |
Completed |
NCT02486640 -
Evaluation of Potential Predictors of Adherence by Investigating a Representative Cohort of Multiple Sclerosis (MS) Patients in Germany Treated With Betaferon
|
||
Completed |
NCT01324232 -
Safety and Efficacy of AVP-923 in the Treatment of Central Neuropathic Pain in Multiple Sclerosis
|
Phase 2 | |
Completed |
NCT04546698 -
5-HT7 Receptor Implication in Inflammatory Mechanisms in Multiple Sclerosis
|
||
Active, not recruiting |
NCT04380220 -
Coagulation/Complement Activation and Cerebral Hypoperfusion in Relapsing-remitting Multiple Sclerosis
|
||
Completed |
NCT02835677 -
Integrating Caregiver Support Into MS Care
|
N/A | |
Completed |
NCT03686826 -
Feasibility and Reliability of Multimodal Evoked Potentials
|
||
Recruiting |
NCT05964829 -
Impact of the Cionic Neural Sleeve on Mobility in Multiple Sclerosis
|
N/A | |
Withdrawn |
NCT06021561 -
Orofacial Pain in Multiple Sclerosis
|
||
Completed |
NCT03653585 -
Cortical Lesions in Patients With Multiple Sclerosis
|
||
Recruiting |
NCT04798651 -
Pathogenicity of B and CD4 T Cell Subsets in Multiple Sclerosis
|
N/A | |
Active, not recruiting |
NCT05054140 -
Study to Evaluate Efficacy, Safety, and Tolerability of IMU-838 in Patients With Progressive Multiple Sclerosis
|
Phase 2 | |
Completed |
NCT05447143 -
Effect of Home Exercise Program on Various Parameters in Patients With Multiple Sclerosis
|
N/A | |
Recruiting |
NCT06195644 -
Effect of Galvanic Vestibular Stimulation on Cortical Excitability and Hand Dexterity in Multiple Sclerosis Patients
|
Phase 1 | |
Completed |
NCT04147052 -
iSLEEPms: An Internet-Delivered Intervention for Sleep Disturbance in Multiple Sclerosis
|
N/A | |
Completed |
NCT03591809 -
Combined Exercise Training in Patients With Multiple Sclerosis
|
N/A | |
Completed |
NCT03594357 -
Cognitive Functions in Patients With Multiple Sclerosis
|
||
Completed |
NCT03269175 -
BENEFIT 15 Long-term Follow-up Study of the BENEFIT and BENEFIT Follow-up Studies
|
Phase 4 |