Efficacy of Diet on Quality of Life in Multiple Sclerosis

NCT05007483 | Active Not Recruiting DMC

• 1 other identifier: 202104639
• Study Type: interventional
• Target: 162
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis, Relapsing-Remitting

Keywords

dietary; nutrition; fatigue; quality of life

Outcome Measures

Primary Outcomes (7)

• Multiple Sclerosis 54 Quality of Life Mental Health (MS 54 QoL MH)

  Change in (MS 54 QoL MH) survey questions mean scores, range 0-100, higher number is better.

  baseline to 3 Months

• Multiple Sclerosis 54 Quality of Life Mental Health (MS 54 QoL MH)

  Change in (MS 54 QoL MH) survey questions mean scores, range 0-100, higher number is better.

  baseline to 6 Months

• Multiple Sclerosis 54 Quality of Life Mental Health (MS 54 QoL MH)

  Change in (MS 54 QoL MH) survey questions mean scores, range 0-100, higher number is better.

  baseline to 12 Months

• Multiple Sclerosis 54 Quality of Life Mental Health (MS 54 QoL MH)

  Change in (MS 54 QoL MH) survey questions mean scores, range 0-100, higher number is better.

  baseline to 18 Months

• Multiple Sclerosis 54 Quality of Life Mental Health (MS 54 QoL MH)

  Change in (MS 54 QoL MH) survey questions mean scores, range 0-100, higher number is better.

  baseline to 24 Months

• Multiple Sclerosis 54 Quality of Life Physical Health (MS 54 QoL PH)

  Change in (MS 54 QoL PH) survey questions mean scores, range 0-100, higher number is better.

  baseline to 3 Months

• Multiple Sclerosis 54 Quality of Life Physical Health (MS 54 QoL PH)

  Change in (MS 54 QoL PH) survey questions mean scores, range 0-100, higher number is better.

  baseline to 6 Months

Secondary Outcomes (35)

• Modified Fatigue Impact Scale (MFIS)

  baseline to 3 months

• Modified Fatigue Impact Scale (MFIS)

  baseline to 6 months

• Modified Fatigue Impact Scale (MFIS)

  baseline to 12 months

• Modified Fatigue Impact Scale (MFIS)

  baseline to 18 months

• Modified Fatigue Impact Scale (MFIS)

  baseline to 24 months

Study Arms (3)

Group 1 (Modified paleolithic elimination diet).

EXPERIMENTAL

Modified paleolithic elimination diet.

Dietary Supplement: BodyBio Balance Oil; Dietary Supplement: Kirunal Fish Oil; Dietary Supplement: BodyBio PC; Behavioral: Modified Paleolithic Elimination diet

Group 2 (TROO)

EXPERIMENTAL

Time Restricted Olive Oil Based (TROO) Ketogenic Diet

Dietary Supplement: BodyBio Balance Oil; Dietary Supplement: Kirunal Fish Oil; Dietary Supplement: BodyBio PC; Behavioral: Time Restricted Olive Oil Based (TROO) Ketogenic Diet

Group 3 Control

ACTIVE COMPARATOR

Usual diet with Dietary Guidelines for Americans Diet information

Behavioral: Usual diet with Dietary Guidelines for Americans Diet information

Interventions

BodyBio Balance Oil DIETARY_SUPPLEMENT

nutraceutical supplement

Also known as: 1400 mg linoleic acid/350 mg linolenic acid

Group 1 (Modified paleolithic elimination diet).; Group 2 (TROO)

Kirunal Fish Oil DIETARY_SUPPLEMENT

nutraceutical supplement

Also known as: 315 mg eicosapentanoic acid/ 105 mg docosahexaenoic acid

Group 1 (Modified paleolithic elimination diet).; Group 2 (TROO)

BodyBio PC DIETARY_SUPPLEMENT

nutraceutical supplement

Also known as: 1300 mg phosphatidylcholine

Group 1 (Modified paleolithic elimination diet).; Group 2 (TROO)

Modified Paleolithic Elimination diet BEHAVIORAL

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.

Group 1 (Modified paleolithic elimination diet).

Time Restricted Olive Oil Based (TROO) Ketogenic Diet BEHAVIORAL

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.

Group 2 (TROO)

Usual diet with Dietary Guidelines for Americans Diet information BEHAVIORAL

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.

Group 3 Control

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.
• 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).

Sponsors & Collaborators

• Terry L. Wahls: lead

Study Sites (1)

Univeristy of Iowa

Iowa City, Iowa, 52246, United States

Location

Related Publications (10)

• Wahls TL, Chenard CA, Snetselaar LG. Review of Two Popular Eating Plans within the Multiple Sclerosis Community: Low Saturated Fat and Modified Paleolithic. Nutrients. 2019 Feb 7;11(2):352. doi: 10.3390/nu11020352.

  PMID: 30736445 RESULT

• Wahls T, Scott MO, Alshare Z, Rubenstein L, Darling W, Carr L, Smith K, Chenard CA, LaRocca N, Snetselaar L. Dietary approaches to treat MS-related fatigue: comparing the modified Paleolithic (Wahls Elimination) and low saturated fat (Swank) diets on perceived fatigue in persons with relapsing-remitting multiple sclerosis: study protocol for a randomized controlled trial. Trials. 2018 Jun 4;19(1):309. doi: 10.1186/s13063-018-2680-x.

  PMID: 29866196 RESULT

• Chenard CA, Rubenstein LM, Snetselaar LG, Wahls TL. Nutrient Composition Comparison between a Modified Paleolithic Diet for Multiple Sclerosis and the Recommended Healthy U.S.-Style Eating Pattern. Nutrients. 2019 Mar 1;11(3):537. doi: 10.3390/nu11030537.

  PMID: 30832289 RESULT

• Titcomb TJ, Bisht B, Moore DD 3rd, Chhonker YS, Murry DJ, Snetselaar LG, Wahls TL. Eating Pattern and Nutritional Risks among People with Multiple Sclerosis Following a Modified Paleolithic Diet. Nutrients. 2020 Jun 20;12(6):1844. doi: 10.3390/nu12061844.

  PMID: 32575774 RESULT

• Lee JE, Bisht B, Hall MJ, Rubenstein LM, Louison R, Klein DT, Wahls TL. A Multimodal, Nonpharmacologic Intervention Improves Mood and Cognitive Function in People with Multiple Sclerosis. J Am Coll Nutr. 2017 Mar-Apr;36(3):150-168. doi: 10.1080/07315724.2016.1255160. Epub 2017 Apr 10.

  PMID: 28394724 RESULT

• Lee JE, Titcomb TJ, Bisht B, Rubenstein LM, Louison R, Wahls TL. A Modified MCT-Based Ketogenic Diet Increases Plasma beta-Hydroxybutyrate but Has Less Effect on Fatigue and Quality of Life in People with Multiple Sclerosis Compared to a Modified Paleolithic Diet: A Waitlist-Controlled, Randomized Pilot Study. J Am Coll Nutr. 2021 Jan;40(1):13-25. doi: 10.1080/07315724.2020.1734988. Epub 2020 Mar 26.

  PMID: 32213121 RESULT

• Chenard CA, Rubenstein LM, Snetselaar LG, Wahls TL. Nutrient Composition Comparison between the Low Saturated Fat Swank Diet for Multiple Sclerosis and Healthy U.S.-Style Eating Pattern. Nutrients. 2019 Mar 13;11(3):616. doi: 10.3390/nu11030616.

  PMID: 30871265 RESULT

• Irish AK, Erickson CM, Wahls TL, Snetselaar LG, Darling WG. Randomized control trial evaluation of a modified Paleolithic dietary intervention in the treatment of relapsing-remitting multiple sclerosis: a pilot study. Degener Neurol Neuromuscul Dis. 2017 Jan 4;7:1-18. doi: 10.2147/DNND.S116949. eCollection 2017.

  PMID: 30050374 RESULT

• Bisht B, Darling WG, Grossmann RE, Shivapour ET, Lutgendorf SK, Snetselaar LG, Hall MJ, Zimmerman MB, Wahls TL. A multimodal intervention for patients with secondary progressive multiple sclerosis: feasibility and effect on fatigue. J Altern Complement Med. 2014 May;20(5):347-55. doi: 10.1089/acm.2013.0188. Epub 2014 Jan 29.

  PMID: 24476345 RESULT

• Shemirani F, Klein AM, Groux AR, Kilpatrick R, Brooks L, Ehlinger MA, Darling WG, Magnotta VA, Gill CM, Hoth KF, Mangalam A, Eyck PT, Martinez AS, Hook J, Titcomb TJ, Snetselaar LG, Wahls TL. Efficacy of Diet on Quality of life in Multiple Sclerosis (EDQ-MS): a study protocol for a randomized controlled clinical trial. Trials. 2025 Oct 27;26(1):437. doi: 10.1186/s13063-025-09157-2.

  PMID: 41146285 DERIVED

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting; Fatigue

Interventions

Eicosapentaenoic Acid; Docosahexaenoic Acids; Phosphatidylcholines; Diet, Ketogenic; Nutrition Policy

Condition Hierarchy (Ancestors)

Multiple Sclerosis; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Fatty Acids, Omega-3; Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils; Glycerophospholipids; Phosphatidic Acids; Glycerophosphates; Phospholipids; Membrane Lipids; Diet, Carbohydrate-Restricted; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Health Policy; Public Policy; Social Control Policies; Policy; Health Care Economics and Organizations

Study Officials

• Terry L Wahls, MD

  University of Iowa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Assessors and principle investigator masked
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principle Investigator

Model Details: Randomized controlled study design

Study Record Dates

• First Submitted: August 9, 2021
• First Posted: August 16, 2021
• Study Start: February 10, 2022
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: September 12, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)