Special Diets for Multiple Sclerosis

(EDQ Trial)

Overseen By Susan Shaffer, BA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Terry L. Wahls

Must not be taking: Insulin, Coumadin, Steroids, others

Disqualifiers: Mental impairment, Cancer, Heart disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

Duration: 24 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how specific diets can improve life quality for people with multiple sclerosis (MS). Participants will follow one of two special diets: a Time Restricted Olive Oil (TROO) ketogenic diet or a modified Paleolithic elimination diet. Researchers will compare their results to usual dietary guidance. The study will focus on effects such as motor function, vision, fatigue, mood, and disease activity. It seeks individuals with relapsing-remitting MS (RRMS) who can prepare home-cooked meals and walk 25 feet without support. As an unphased trial, this study offers a unique opportunity to contribute to understanding how dietary changes can impact MS symptoms.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you've recently changed treatments or are using certain medications like insulin or Coumadin.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the Modified Paleolithic Elimination diet may help reduce fatigue in people with multiple sclerosis (MS). This diet, similar to what early humans might have eaten, is rich in vitamins and nutrients that support overall health. Studies have not identified any major safety concerns with this diet.

The Time Restricted Olive Oil Based (TROO) Ketogenic Diet may also improve the quality of life for people with MS, according to research. This diet emphasizes healthy fats, like olive oil, and involves eating only during specific times of the day. Like the Paleolithic diet, studies have not reported significant safety issues. Both diets are generally well-tolerated and usually don't cause serious side effects. However, individual experiences can vary, so consulting a healthcare provider before starting any new diet is always advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these dietary approaches for multiple sclerosis (MS) because they offer unique alternatives to traditional treatments like disease-modifying therapies. The Modified Paleolithic Elimination diet focuses on reducing potential dietary triggers by eliminating certain foods, which might help in managing inflammation and symptoms. Meanwhile, the Time Restricted Olive Oil Based (TROO) Ketogenic Diet combines the benefits of time-restricted eating with a high-fat, low-carb approach, potentially improving energy metabolism and reducing fatigue, a common MS symptom. These diets aim to provide a more holistic way to manage MS by leveraging natural food-based strategies.

What evidence suggests that this trial's dietary interventions could be effective for improving quality of life in multiple sclerosis?

This trial will compare the Modified Paleolithic Elimination diet and the Time Restricted Olive Oil Based (TROO) Ketogenic Diet for people with multiple sclerosis (MS). Studies have shown that the Modified Paleolithic Elimination diet can reduce tiredness and enhance well-being in people with MS. Similarly, the TROO Ketogenic Diet has been linked to a better quality of life and less fatigue. These dietary changes seem to alleviate symptoms like tiredness and may support other treatments. Overall, evidence suggests that both diets could help manage MS symptoms. ^{1 2 4 6 7}

Who Is on the Research Team?

Terry L Wahls, MD, MBA

Principal Investigator

University of Iowa

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Must consent to sharing the clinical notes from their primary care and neurology providers during the study period.

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.

Exclusion Criteria

Confirmation of pregnancy or planning to become pregnant in the next 2 years

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.

My condition worsened, leading to a change in my treatment or new steroids in the last 4 weeks.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

1 visit (in-person)

Run-in

Fourteen-day run-in period to identify participants likely to complete study procedures

2 weeks

1 visit (in-person)

Treatment

Participants receive dietary interventions or control diet and are monitored for MS symptoms and quality of life

24 months

3 visits (in-person at months 0, 3, and 24), online surveys every 3 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• BodyBio Balance Oil
• BodyBio PC
• Dietary Guidelines for Americans Diet
• Kirunal Fish Oil
• Modified Paleolithic Elimination diet
• Time Restricted Olive Oil Based (TROO) Ketogenic Diet

Trial Overview 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.

How Is the Trial Designed?

Group I: Group 2 (TROO) Experimental Treatment 4 Interventions

Time Restricted Olive Oil Based (TROO) Ketogenic Diet

Group II: Group 1 (Modified paleolithic elimination diet). Experimental Treatment 4 Interventions

Modified paleolithic elimination diet.

Group III: Group 3 Control Active Control 1 Intervention

Usual diet with Dietary Guidelines for Americans Diet information

Who Is Running the Clinical Trial?

Terry L. Wahls

Lead Sponsor

Trials

6

Recruited

400+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6412750/

Low Saturated Fat and Modified Paleolithic - PubMed Central Fatigue and QOL improved after three months on the Wahls™ diet compared to participants randomized to their usual diet [35]. Study strengths include ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05007483

Efficacy of Diet on Quality of Life in Multiple Sclerosis The primary objective of this study is to evaluate the effect of two dietary interventions (time restricted olive oil based (TROO) ketogenic and modified ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10243296/

Effectiveness of various diet patterns among patients with ... An appropriate and balanced diet can be extremely helpful in improving the condition and well-being of patients with MS, and effectively support drug therapy.

4. trialsjournal.biomedcentral.com trialsjournal.biomedcentral.com/articles/10.1186/s13063-025-09157-2

Efficacy of Diet on Quality of life in Multiple Sclerosis (EDQ-MS) Results from several studies suggest that diet quality is inversely associated with symptoms of MS, including disability [13], fatigue, ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT01915433

Wahls Paleo Diet and Progressive Multiple Sclerosis The study diet is based upon a Paleolithic Diet, also known as a Hunter Gatherer Diet, which exceeds the recommended daily allowance of water soluble vitamins ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7353368/

Eating Pattern and Nutritional Risks among People with ... Preliminary studies suggest that a modified Paleolithic diet may benefit symptoms of fatigue in progressive multiple sclerosis (MS).

7. mdpi.com mdpi.com/2072-6643/11/3/537

Nutrient Composition Comparison between a Modified ... Nutrient Composition Comparison between a Modified Paleolithic Diet for Multiple Sclerosis and the Recommended Healthy U.S.-Style Eating Pattern.