Your session is about to expire
← Back to Search
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 24 months
Awards & highlights
EDQ Trial Summary
This trial will compare the effects of two dietary interventions (time restricted olive oil based (TROO) ketogenic and modified Paleolithic elimination) on MS quality of life, compared to usual care control (Dietary Guidelines for America).
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.Check my eligibility
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.See study design
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.
EDQ Trial 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.
Select...
I can walk 25 feet on my own without help.
Select...
I am between 18 and 70 years old.
Select...
I am between 18 and 70 years old.
EDQ Trial 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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 outcome measures
24 hour dietary intake recalls
9 Hole peg board test
Brain lesions as measured by non contrast magnetic resonance imaging (MRI)
+9 moreEDQ 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
Find a Location
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
Media Library
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 1 (Modified paleolithic elimination diet).
- Group 2: Group 3 Control
- 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
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this experiment accept participants aged sixty-five or above?
"The eligibility criteria for this medical trial stipulates that the minimum age of participants is 18 and the maximum permitted age is 70."
Answered by AI
What goals has this medical experiment been designed to accomplish?
"During this two-year clinical trial, the primary objective is to assess Multiple sclerosis 54 Quality of Life Mental health (MS 54 QoL MH). Secondary objectives include recording any changes in Modified Fatigue Impact Scale (MFIS), Hospital Anxiety Depression Scale (HADS) and Fatigue Severity Scale score (FSS)."
Answered by AI
Is there a possibility that I may be eligible to participate in this experiment?
"This research study seeks to recruit 156 individuals who have been diagnosed with multiple sclerosis, acute relapsing and are between 18-70 years old."
Answered by AI
How many individuals are participating in this trial?
"Affirmative. According to information available on clinicaltrials.gov, this medical trial has been actively recruiting since February 10th 2022 and is looking for 156 participants at 1 site. The data was last updated on June 30th 2022."
Answered by AI
Are there any vacancies available to participants in this trial?
"Indeed, the details provided on clinicaltrials.gov validate that this study is actively seeking participants. The trial was first listed on February 10th 2022 and it has been updated as recently as June 30th 2022. 156 individuals need to be recruited at one medical centre for participation in the trial."
Answered by AI
Who else is applying?
What state do they live in?
New Mexico
Virginia
Missouri
What site did they apply to?
Univeristy of Iowa
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
1
3+
Why did patients apply to this trial?
I am interested in helping those with ms and learning more myself. I believe that the diet habits are most important in healing process. I can see big connections between diet and symptoms, but my doctor doesn’t. And would like to help other people to overcome disease and live a life full of happiness.
PatientReceived 1 prior treatment
I think certain diets can play an important role in how patients with MS feel. I have fasted before and felt wonderful. I currently do intermittent fasting, but don’t follow a specific diet. Knowledge is power. I would love to stop taking the medication I’m on.
PatientReceived 1 prior treatment
What questions have other patients asked about this trial?
Am I supposed to stop taking my MS meds on this trial? Do I need to have any specific health insurance coverage or pay for any tests or MRI?
PatientReceived no prior treatments
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger