What is the mechanism of action of this treatment?

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.

What side effects are associated with this type of intervention?

Common treatments for Multiple Sclerosis (MS) include disease-modifying therapies such as dimethyl fumarate (BG-12) and glatiramer acetate, which can cause side effects like flushing, gastrointestinal issues, and injection site reactions. Dietary interventions like the Time Restricted Olive Oil Based (TROO) Ketogenic Diet and Modified Paleolithic Elimination Diet, which aim to improve metabolic health and reduce inflammation, may lead to side effects such as nutrient deficiencies, gastrointestinal discomfort, and difficulty adhering to the dietary restrictions. It is important to discuss these potential side effects with a healthcare provider to ensure a balanced approach to managing MS.

What prior FDA approvals exist?

FDA-approved treatments for Multiple Sclerosis (MS) primarily include disease-modifying therapies (DMTs) such as glatiramer acetate, which modulates the immune response to reduce inflammation and neurodegeneration. While specific dietary interventions like the Time Restricted Olive Oil Based (TROO) Ketogenic Diet and Modified Paleolithic Elimination Diet are not FDA-approved treatments, they aim to improve metabolic health and reduce inflammation, which are crucial in managing MS symptoms. These dietary approaches are complementary to traditional DMTs and focus on enhancing the overall quality of life for MS patients.

What other types of research exist?

Promising novel alternatives to the TROO Ketogenic Diet and Modified Paleolithic Elimination Diet for MS patients include: 1) Mediterranean Diet: Emphasizes plant-based foods, healthy fats, and lean proteins, and has shown potential in reducing inflammation and improving metabolic health. 2) Intermittent Fasting: Various forms of intermittent fasting, such as the 5:2 diet or alternate-day fasting, have been associated with reduced inflammation and improved metabolic markers. 3) Anti-Inflammatory Diet: Focuses on foods known to reduce inflammation, such as fruits, vegetables, whole grains, fatty fish, and nuts. These diets are supported by emerging research and may offer benefits for MS patients.

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Special Diets for Multiple Sclerosis (EDQ Trial)

N/A

Recruiting

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 below

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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:

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 24 months for reporting.

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 more

Awards & 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

0 / 10Eligibility criteria met

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.