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

162 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Terry L Wahls, MD, MBA

Principal Investigator

University of Iowa

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+