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Special Diets for Multiple Sclerosis (EDQ Trial)
N/A
Waitlist Available
Led By Terry L Wahls, MD
Research Sponsored by Terry L. Wahls
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Must be able to walk 25 feet without support.
Must be able to walk 25 feet without support
Must not have
Diagnosis of clinically significant heart disease, liver disease, kidney disease, or history of oxalate kidney stones
History of diagnosed fat intolerance/malabsorption such as cholecystectomy or uncontrolled exocrine pancreatic insufficiency
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 24 months
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing two special diets to see if they can help people with multiple sclerosis (MS). One diet uses olive oil, while the other avoids certain modern foods. The goal is to see if these diets can improve symptoms like pain, fatigue, and vision problems by reducing inflammation and providing essential nutrients.
Who is the study for?
This trial is for adults aged 18-70 with Relapsing-Remitting Multiple Sclerosis (RRMS) who can walk unaided and are willing to follow one of the study diets. Participants need internet access for surveys, must share medical notes, and be able to prepare or have someone prepare meals at home. Those with severe mental impairment, certain medication use, recent other treatments or studies, significant diseases, pregnancy plans within two years, eating disorders or severe psychiatric conditions cannot join.
What is being tested?
The trial evaluates how different diets affect quality of life in MS patients compared to usual care based on Dietary Guidelines for America. It tests a time-restricted olive oil-based ketogenic diet and a modified Paleolithic elimination diet against usual care. Effects on motor function, vision sensitivity, fatigue mood and brain activity will also be studied.
What are the potential side effects?
Potential side effects may include digestive changes due to new dietary habits; however specific side effects will depend on individual responses to the dietary interventions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can walk 25 feet on my own without help.
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I can walk 25 feet on my own without help.
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I am between 18 and 70 years old.
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I am between 18 and 70 years old.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a history of serious heart, liver, kidney disease, or oxalate kidney stones.
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I have a condition that makes it hard for my body to absorb fats.
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I haven't had cancer treatment except for skin cancer in the last year.
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I have moderate or severe difficulties with my mental functions.
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I am currently using insulin, Coumadin, or weight loss medications like orlistat.
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My doctor has not approved me for any of the study diets for my type II diabetes.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 24 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Multiple Sclerosis 54 Quality of Life Mental Health (MS 54 QoL MH)
Multiple Sclerosis 54 Quality of Life Physical Health (MS 54 QoL PH)
Secondary study objectives
24 hour dietary intake recalls
9 Hole peg board test
Brain lesions as measured by non contrast magnetic resonance imaging (MRI)
+9 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Group 2 (TROO)Experimental Treatment4 Interventions
Time Restricted Olive Oil Based (TROO) Ketogenic Diet
Group II: Group 1 (Modified paleolithic elimination diet).Experimental Treatment4 Interventions
Modified paleolithic elimination diet.
Group III: Group 3 ControlActive Control1 Intervention
Usual diet with Dietary Guidelines for Americans Diet information
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Multiple Sclerosis (MS) include dietary interventions like the Time Restricted Olive Oil Based (TROO) Ketogenic Diet and the Modified Paleolithic Elimination Diet, which focus on improving metabolic health and reducing inflammation. These diets are believed to help by stabilizing blood sugar levels, reducing oxidative stress, and decreasing pro-inflammatory cytokines, which can potentially alleviate MS symptoms and improve quality of life.
Other common treatments include disease-modifying therapies such as dimethyl fumarate and glatiramer acetate, which work by modulating the immune system to reduce the frequency and severity of relapses and slow disease progression. These treatments are essential for MS patients as they target the underlying mechanisms of the disease, aiming to reduce inflammation, prevent nerve damage, and improve overall neurological function.
Dietary Interventions in Multiple Sclerosis: Development and Pilot-Testing of an Evidence Based Patient Education Program.
Dietary Interventions in Multiple Sclerosis: Development and Pilot-Testing of an Evidence Based Patient Education Program.
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Who is running the clinical trial?
Terry L. WahlsLead Sponsor
5 Previous Clinical Trials
239 Total Patients Enrolled
4 Trials studying Multiple Sclerosis
239 Patients Enrolled for Multiple Sclerosis
Terry L Wahls, MDPrincipal InvestigatorUniversity of Iowa
4 Previous Clinical Trials
139 Total Patients Enrolled
3 Trials studying Multiple Sclerosis
139 Patients Enrolled for Multiple Sclerosis
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a moderate to severe psychiatric condition such as schizophrenia, bipolar disorder, or severe depression that could make it hard for you to follow the study instructions.This criterion is not related to clinical trial exclusion criteria. Can you provide another criterion related to clinical trials?You have been diagnosed with RRMS using the 2017 revised McDonald Criteria.I can walk 25 feet on my own without help.I can walk 25 feet on my own without help.My condition worsened, leading to a change in my treatment or new steroids in the last 4 weeks.You are currently taking part in another study about treatments, diet, or exercise for MS.I have a history of serious heart, liver, kidney disease, or oxalate kidney stones.I have a condition that makes it hard for my body to absorb fats.Your body mass index (BMI) is less than 20.You have an active eating disorder like anorexia, bulimia, binge eating, or orthorexia.I haven't had cancer treatment except for skin cancer in the last year.You can't have a brain MRI because it's not safe for you or you feel very scared in small places.I am between 18 and 70 years old.I have moderate or severe difficulties with my mental functions.I am currently using insulin, Coumadin, or weight loss medications like orlistat.I am between 18 and 70 years old.My doctor has not approved me for any of the study diets for my type II diabetes.You have been diagnosed with RRMS using specific guidelines from 2017.You can make your own meals at home, or have someone who can make them for you.
Research Study Groups:
This trial has the following groups:- Group 1: Group 3 Control
- Group 2: Group 1 (Modified paleolithic elimination diet).
- Group 3: Group 2 (TROO)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Multiple Sclerosis Patient Testimony for trial: Trial Name: NCT05007483 — N/A