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Efficacy of Diet on Quality of Life in Multiple Sclerosis (EDQ)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05007483
Recruitment Status : Recruiting
First Posted : August 16, 2021
Last Update Posted : July 5, 2022
Sponsor:
Information provided by (Responsible Party):
Terry L. Wahls, University of Iowa

Brief Summary:
The overarching goal of this project is to critically evaluate the efficacy of incorporating dietary guidance within multiple sclerosis (MS) care for improving long-term quality of life (QoL) compared to usual care. The primary objective of this study is to evaluate the effect of two dietary interventions (time restricted olive oil based (TROO) ketogenic and modified Paleolithic elimination) on MS QoL compared to usual care control (Dietary Guidelines for America), and the secondary objectives and the long-term effects on, motor function, low-contrast vision sensitivity, fatigue, mood, and disease activity assessed by brain imaging.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis, Relapsing-Remitting Dietary Supplement: BodyBio Balance Oil Dietary Supplement: Kirunal Fish Oil Dietary Supplement: BodyBio PC Behavioral: Modified Paleolithic Elimination diet Behavioral: Time Restricted Olive Oil Based (TROO) Ketogenic Diet Behavioral: Usual diet with Dietary Guidelines for Americans Diet information Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 156 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized controlled study design
Masking: Double (Investigator, Outcomes Assessor)
Masking Description: Assessors and principle investigator masked
Primary Purpose: Supportive Care
Official Title: Efficacy of Diet on Quality of Life in Multiple Sclerosis
Actual Study Start Date : February 10, 2022
Estimated Primary Completion Date : March 1, 2025
Estimated Study Completion Date : March 1, 2026

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group 1 (Modified paleolithic elimination diet).
Modified paleolithic elimination diet.
Dietary Supplement: BodyBio Balance Oil
nutraceutical supplement
Other Name: 1400 mg linoleic acid/350 mg linolenic acid

Dietary Supplement: Kirunal Fish Oil
nutraceutical supplement
Other Name: 315 mg eicosapentanoic acid/ 105 mg docosahexaenoic acid

Dietary Supplement: BodyBio PC
nutraceutical supplement
Other Name: 1300 mg phosphatidylcholine

Behavioral: Modified Paleolithic Elimination diet
  1. Complete elimination of all gluten-, dairy-, and egg-containing foods.
  2. Increase fruit and vegetable intake to 6-9 servings/day comprising of 2-3 servings each of the following categories: intensely colored, sulfur-rich, and leafy greens.
  3. Consume 6-12 ounces/day protein including organ meats and fatty fish.
  4. Consume fermented foods daily.
  5. Consume daily servings of algae, seaweed, and nutritional yeast.

Experimental: Group 2 (TROO)
Time Restricted Olive Oil Based (TROO) Ketogenic Diet
Dietary Supplement: BodyBio Balance Oil
nutraceutical supplement
Other Name: 1400 mg linoleic acid/350 mg linolenic acid

Dietary Supplement: Kirunal Fish Oil
nutraceutical supplement
Other Name: 315 mg eicosapentanoic acid/ 105 mg docosahexaenoic acid

Dietary Supplement: BodyBio PC
nutraceutical supplement
Other Name: 1300 mg phosphatidylcholine

Behavioral: Time Restricted Olive Oil Based (TROO) Ketogenic Diet
  1. Restriction of dietary carbohydrates to < 50 grams/day.
  2. Use olive oil (cold-pressed extra virgin preferred) to increase fat intake to >160 grams/day.
  3. Consume <100 grams/day protein.
  4. Limit dairy to 2 servings/day of whole fat options (completely exclude reduced fat dairy).
  5. Consume at least 3 servings/day non-starchy vegetables.

Active Comparator: Group 3 Control
Usual diet with Dietary Guidelines for Americans Diet information
Behavioral: Usual diet with Dietary Guidelines for Americans Diet information
  1. Limit sodium to < 2,300 mg/day.
  2. Limit added sugar and saturated fat intake to <10% of kcal/day, respectively.
  3. Consume 5 servings of fruits and vegetables per day.
  4. Consume 6-9 ounce equivalents/day of grains, making at least half whole grain options.
  5. Consume 3 servings of reduced fat dairy per day.
  6. Consume 6 ounces/day protein foods.




Primary Outcome Measures :
  1. Multiple Sclerosis 54 Quality of Life Mental Health (MS 54 QoL MH) [ Time Frame: baseline to 3 Months ]
    Change in (MS 54 QoL MH) survey questions mean scores, range 0-100, higher number is better.

  2. Multiple Sclerosis 54 Quality of Life Mental Health (MS 54 QoL MH) [ Time Frame: baseline to 6 Months ]
    Change in (MS 54 QoL MH) survey questions mean scores, range 0-100, higher number is better.

  3. Multiple Sclerosis 54 Quality of Life Mental Health (MS 54 QoL MH) [ Time Frame: baseline to 12 Months ]
    Change in (MS 54 QoL MH) survey questions mean scores, range 0-100, higher number is better.

  4. Multiple Sclerosis 54 Quality of Life Mental Health (MS 54 QoL MH) [ Time Frame: baseline to 18 Months ]
    Change in (MS 54 QoL MH) survey questions mean scores, range 0-100, higher number is better.

  5. Multiple Sclerosis 54 Quality of Life Mental Health (MS 54 QoL MH) [ Time Frame: baseline to 24 Months ]
    Change in (MS 54 QoL MH) survey questions mean scores, range 0-100, higher number is better.

  6. Multiple Sclerosis 54 Quality of Life Physical Health (MS 54 QoL PH) [ Time Frame: baseline to 3 Months ]
    Change in (MS 54 QoL PH) survey questions mean scores, range 0-100, higher number is better.

  7. Multiple Sclerosis 54 Quality of Life Physical Health (MS 54 QoL PH) [ Time Frame: baseline to 6 Months ]
    Change in (MS 54 QoL PH) survey questions mean scores, range 0-100, higher number is better.

  8. Multiple Sclerosis 54 Quality of Life Physical Health (MS 54 QoL PH) [ Time Frame: baseline to 12 Months ]
    Change in (MS 54 QoL PH) survey questions mean scores, range 0-100, higher number is better.

  9. Multiple Sclerosis 54 Quality of Life Physical Health (MS 54 QoL PH) [ Time Frame: baseline to 18 Months ]
    Change in (MS 54 QoL PH) survey questions mean scores, range 0-100, higher number is better.

  10. Multiple Sclerosis 54 Quality of Life Physical Health (MS 54 QoL PH) [ Time Frame: baseline to 24 Months ]
    Change in (MS 54 QoL PH) survey questions mean scores, range 0-100, higher number is better.


Secondary Outcome Measures :
  1. Modified Fatigue Impact Scale (MFIS) [ Time Frame: baseline to 3 months ]
    Change in MFIS survey questions, scores range from 0-84, lower score is better.

  2. Modified Fatigue Impact Scale (MFIS) [ Time Frame: baseline to 6 months ]
    Change in MFIS survey questions, scores range from 0-84, lower score is better.

  3. Modified Fatigue Impact Scale (MFIS) [ Time Frame: baseline to 12 months ]
    Change in MFIS survey questions, scores range from 0-84, lower score is better.

  4. Modified Fatigue Impact Scale (MFIS) [ Time Frame: baseline to 18 months ]
    Change in MFIS survey questions, scores range from 0-84, lower score is better.

  5. Modified Fatigue Impact Scale (MFIS) [ Time Frame: baseline to 24 months ]
    Change in MFIS survey questions, scores range from 0-84, lower score is better.

  6. Hospital Anxiety Depression Scale (HADS) [ Time Frame: baseline to 3 months ]
    Change in HADS survey question score, a 14 question scale ranging from 0-3 with zero being being low or no occurrence and 3 being high occurrence

  7. Hospital Anxiety Depression Scale (HADS) [ Time Frame: baseline to 6 months ]
    Change in HADS survey question score, a 14 question scale ranging from 0-3 with zero being being low or no occurrence and 3 being high occurrence

  8. Hospital Anxiety Depression Scale (HADS) [ Time Frame: baseline to 12 months ]
    Change in HADS survey question score, a 14 question scale ranging from 0-3 with zero being being low or no occurrence and 3 being high occurrence

  9. Hospital Anxiety Depression Scale (HADS) [ Time Frame: baseline to 18 months ]
    Change in HADS survey question score, a 14 question scale ranging from 0-3 with zero being being low or no occurrence and 3 being high occurrence

  10. Hospital Anxiety Depression Scale (HADS) [ Time Frame: baseline to 24 months ]
    Change in HADS survey question score, a 14 question scale ranging from 0-3 with zero being being low or no occurrence and 3 being high occurrence

  11. Fatigue Severity Scale score (FSS) [ Time Frame: Baseline to 3 months ]
    Change in FSS survey question mean scores, scores range from 1-7, lower is better.

  12. Fatigue Severity Scale score (FSS) [ Time Frame: Baseline to 6 months ]
    Change in FSS survey question mean scores, scores range from 1-7, lower is better.

  13. Fatigue Severity Scale score (FSS) [ Time Frame: Baseline to 12 months ]
    Change in FSS survey question mean scores, scores range from 1-7, lower is better.

  14. Fatigue Severity Scale score (FSS) [ Time Frame: Baseline to 18 months ]
    Change in FSS survey question mean scores, scores range from 1-7, lower is better.

  15. Fatigue Severity Scale score (FSS) [ Time Frame: Baseline to 24 months ]
    Change in FSS survey question mean scores, scores range from 1-7, lower is better.

  16. Brain volume as measured by non contrast magnetic resonance imaging (MRI) [ Time Frame: baseline to 24 months ]
    Change in MRI grey matter brain volume, more is better

  17. Brain lesions as measured by non contrast magnetic resonance imaging (MRI) [ Time Frame: baseline to 24 months ]
    Change in inflammatory lesions numbers as measured by non contrast brain MRI, fewer is better

  18. Timed 25 foot walk test [ Time Frame: baseline to 3 months ]
    seconds required to walk 25 feet, lower is better

  19. Timed 25 foot walk test [ Time Frame: baseline to 24 months ]
    seconds required to walk 25 feet, lower is better

  20. 9 Hole peg board test [ Time Frame: baseline to 3 months ]
    seconds require to move 9 pegs to various locations on a peg board, fewer seconds is better

  21. 9 Hole peg board test [ Time Frame: baseline to 24 months ]
    seconds require to move 9 pegs to various locations on a peg board, fewer seconds is better

  22. Low contrast visual acuity [ Time Frame: baseline to 3 months ]
    A measure of best corrected vision, measure is log minimal angle of resolution at 2.5% contrast. Lower number is better.

  23. Low contrast visual acuity [ Time Frame: baseline to 24 months ]
    A measure of best corrected vision, measure is log minimal angle of resolution at 2.5% contrast. Lower number is better.

  24. 24 hour dietary intake recalls [ Time Frame: baseline to 12 months ]
    Change in dietary intake measured by dietary interview conducted via telephone call; more nutrients meeting recommended dietary allowance is better.

  25. 24 hour dietary intake recalls [ Time Frame: baseline to 24 months ]
    Change in dietary intake measured by dietary interview conducted via telephone call; more nutrients meeting recommended dietary allowance is better.

  26. Critical flicker fusion [ Time Frame: baseline to 3 months ]
    The herz at which a flickering light is seen as non-flickering as measured by herz

  27. Critical flicker fusion [ Time Frame: baseline to 24 months ]
    The herz at which a flickering light is seen as non-flickering as measured by herz

  28. Ocular Coherence tomography [ Time Frame: baseline ]
    Measure of optic nerve and retina depths using infrared light technology

  29. Neurofilament light chain [ Time Frame: baseline to 3 months ]
    blood biomarker of neuroaxonal (brain) damage

  30. Neurofilament light chain [ Time Frame: baseline to 24 months ]
    blood biomarker of neuroaxonal (brain) damage



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Eligibility for the run-in phase of the study:

Participants will be eligible to enroll in the fourteen-day run-in phase of the study if they meet the following inclusion and exclusion criteria:

INCLUSION CRITERIA:

  • A definitive diagnosis of RRMS based on the 2017 revised McDonald Criteria.
  • The ability to prepare, or availability of someone to prepare, home-cooked meals.
  • Must own a computer, smartphone, or tablet device that has internet access to complete online surveys and capable of running study related applications.
  • Must be willing to follow study procedures outlined and explained to them.
  • Be between the ages of 18 to 70 at the time of consent.
  • Must be able to walk 25 feet without support.
  • Willingness to be randomized and follow any of the study diets.
  • Must consent to sharing the clinical notes from their primary care and neurology providers during the study period.

EXCLUSION CRITERIA:

  • Moderate or severe mental impairment.
  • Use of insulin, Coumadin, weight loss medications such as orlistat that causes fat malabsorption.
  • Worsening of symptoms resulting in the initiation or change of treatment including steroids (solumedrol, prednisone, etc.) or disease-modifying medications in 4 weeks prior to consent.
  • Treatment for cancer by radiation or chemotherapy in 12 months prior to consent, other than skin cancer.
  • Diagnosis of clinically significant heart disease, liver disease, kidney disease, or history of oxalate kidney stones.
  • Diagnosis of type II diabetes that does not have approval from treating physicians to adopt any of the 3 study diets.
  • Clinical diagnosis of moderate to severe psychiatric disease that makes study adherence more difficult (e.g., schizophrenia, bi-polar disease, severe depression and/or anxiety).
  • An active eating disorder such as anorexia, bulimia, binge eating, or orthorexia.
  • Measurement of BMI <20.
  • Confirmation of pregnancy or planning to become pregnant in the next 2 years.
  • History of diagnosed fat intolerance/malabsorption such as cholecystectomy or uncontrolled exocrine pancreatic insufficiency.
  • Participation in another research study investigating MS treatments, diet, or exercise.
  • Presence of a contraindication to completing a brain MRI or having claustrophobia which interferes with completion of MRI studies without the use of sedation.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05007483


Contacts
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Contact: Mary Ehlinger, BS 319 384 5002 MSDietStudy@healthcare.uiowa.edu
Contact: Susan Shaffer, BA 319 356 4421 susan-shaffer@uiowa.edu

Locations
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United States, Iowa
Univeristy of Iowa Recruiting
Iowa City, Iowa, United States, 52246
Contact: Mary Ehlinger, BS    319-384-5002    MSDietStudy@healthcare.uiowa.edu   
Contact: Susan Shaffer, BA    319 356 4421    susan-shaffer@uiowa.edu   
Principal Investigator: Terry Wahls, MD         
Sub-Investigator: Linda Snetselaar, PhD, RD         
Sub-Investigator: Vince Magnotta, PhD         
Sponsors and Collaborators
Terry L. Wahls
Investigators
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Principal Investigator: Terry L Wahls, MD University of Iowa
Publications of Results:

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Responsible Party: Terry L. Wahls, Principle Investigator, University of Iowa
ClinicalTrials.gov Identifier: NCT05007483    
Other Study ID Numbers: 202104639
First Posted: August 16, 2021    Key Record Dates
Last Update Posted: July 5, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Terry L. Wahls, University of Iowa:
dietary
nutrition
fatigue
quality of life
Additional relevant MeSH terms:
Layout table for MeSH terms
Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases