Multiple Sclerosis, Relapsing-RemittingEDQNCT05007483
Efficacy of Diet on Quality of Life in Multiple Sclerosis
A study testing BodyBio Balance Oil, Kirunal Fish Oil and BodyBio PC in people with Multiple Sclerosis, Relapsing-Remitting, run by Terry L. Wahls at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis, Relapsing-Remitting
- What is being tested?
- BodyBio Balance Oil, Kirunal Fish Oil and BodyBio PC
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 162 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Feb 2022to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
In the United States, MS affects nearly 1 million people with a 2.8:1 female to male ratio and the highest incidence rates among whites and African Americans. The economic cost of managing MS is substantial. In the U.S., the total medical costs for patients with MS increased from $116 million in 2002 to $198 million in 2013. MS is a chronic, neuroinflammatory, and neurodegenerative disease-causing symptoms of pain, fatigue, and changes in vision, cognition, and movement that greatly reduce quality of life (QoL) and the ability to maintain employment.
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.
The proposed study will consist of study participants attending 3 in-person site visits, months 0, 3, and 24, and online surveys every 3 months (months 0-24).
This study will use a randomized single-blind controlled design to test the short-term (6 months) and long-term (an additional 18 months) impact of the intervention diets on symptoms of MS including QoL and related outcomes stated above. We will use a fourteen-day run-in period to identify participants who are most likely to be successful in completing study procedures; this process has been effective in our previous studies. Participants who successfully complete all baseline self-reported outcomes and follow all study procedures during the seven-day run-in period will be scheduled for an on-site baseline visit for randomization to one of three diets (time restricted olive oil based (TROO) ketogenic and modified Paleolithic elimination and Dietary Guidelines for America).
On-site study visits will include blood draws, motor, cognitive, vision function assessments, and MRI. Motor assessments will include a 6-minute walk test, 25-foot walk test, 9-hole pegboard to test hand function, symbol digit exercise to test thinking functions, and critical flicker fusion test, ocular coherence tomography and low contrast vision sensitivity to test vision. The study participant will be escorted to the MRI unit to complete a non-contrast MRI of the brain. At the baseline visit, participants will be randomized. Participants assigned to the intervention diets will be given intervention specific educational materials including shopping lists, example menus and recipes, and the study supplements. Study participants randomized to the dietary guidelines for Americans diet will receive emails and/or text messages (approximately 3-6 weeks) to receive resources with websites for the Dietary Guidelines of America, and recent multiple sclerosis-related research that does not involve diet.
Study team will provide fish oil, essential fatty acids, and phosphatidylcholine to the two intervention groups only. The participant will be scheduled for a Zoom video conference meeting with the assigned registered dietitian to review the assigned study diet.
In addition, subjects will collect saliva specimens for microbiome analysis at each of the 3 site study visits (months 0, 3 and 24).
Dietary History Questionnaire III will be completed at months 0, 3, 12 and 24 and will be used to assess adherence to the assigned dietary pattern.
The online questionnaires sent to participants every 3 months will also be used to track supplement intake, medication use, and details about health \& life events, MS symptoms, fatigue, quality of life, doctor's appointment, and side effects they may be experiencing.
- Conditions
- Multiple Sclerosis, Relapsing-Remitting
- Being tested
- BodyBio Balance Oil, Kirunal Fish Oil, BodyBio PC, Modified Paleolithic Elimination diet, Time Restricted Olive Oil Based (TROO) Ketogenic Diet
- Keywords
- dietary, nutrition, fatigue, quality of life
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BodyBio Balance OilDietary supplement
Also called 1400 mg linoleic acid/350 mg linolenic acid
nutraceutical supplement
Kirunal Fish OilDietary supplement
Also called 315 mg eicosapentanoic acid/ 105 mg docosahexaenoic acid
nutraceutical supplement
BodyBio PCDietary supplement
Also called 1300 mg phosphatidylcholine
nutraceutical supplement
Modified Paleolithic Elimination dietBehavioural
- Complete elimination of all gluten-, dairy-, and egg-containing foods.
- 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.
- Consume 6-12 ounces/day protein including organ meats and fatty fish.
- Consume fermented foods daily.
- Consume daily servings of algae, seaweed, and nutritional yeast.
Time Restricted Olive Oil Based (TROO) Ketogenic DietBehavioural
- Restriction of dietary carbohydrates to < 50 grams/day.
- Use olive oil (cold-pressed extra virgin preferred) to increase fat intake to >160 grams/day.
- Consume <100 grams/day protein.
- Limit dairy to 2 servings/day of whole fat options (completely exclude reduced fat dairy).
- Consume at least 3 servings/day non-starchy vegetables.
Usual diet with Dietary Guidelines for Americans Diet informationBehavioural
- Limit sodium to < 2,300 mg/day.
- Limit added sugar and saturated fat intake to <10% of kcal/day, respectively.
- Consume 5 servings of fruits and vegetables per day.
- Consume 6-9 ounce equivalents/day of grains, making at least half whole grain options.
- Consume 3 servings of reduced fat dairy per day.
- Consume 6 ounces/day protein foods.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (Modified paleolithic elimination diet). | Experimental | Modified paleolithic elimination diet. Receives: 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 Receives: 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 Receives: Behavioral: Usual diet with Dietary Guidelines for Americans Diet information |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: baseline to 6 Months
Secondary outcomes (35)
Modified Fatigue Impact Scale (MFIS)
Change in MFIS survey questions, scores range from 0-84, lower score is better.
Measured: baseline to 3 months
Modified Fatigue Impact Scale (MFIS)
Change in MFIS survey questions, scores range from 0-84, lower score is better.
Measured: baseline to 6 months
Modified Fatigue Impact Scale (MFIS)
Change in MFIS survey questions, scores range from 0-84, lower score is better.
Measured: baseline to 12 months
Modified Fatigue Impact Scale (MFIS)
Change in MFIS survey questions, scores range from 0-84, lower score is better.
Measured: baseline to 18 months
Modified Fatigue Impact Scale (MFIS)
Change in MFIS survey questions, scores range from 0-84, lower score is better.
Measured: baseline to 24 months
Hospital Anxiety Depression Scale (HADS)
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
Measured: baseline to 3 months
Hospital Anxiety Depression Scale (HADS)
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
Measured: baseline to 6 months
Hospital Anxiety Depression Scale (HADS)
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
Measured: baseline to 12 months
Hospital Anxiety Depression Scale (HADS)
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
Measured: baseline to 18 months
Hospital Anxiety Depression Scale (HADS)
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
Measured: baseline to 24 months
Fatigue Severity Scale score (FSS)
Change in FSS survey question mean scores, scores range from 1-7, lower is better.
Measured: Baseline to 3 months
Fatigue Severity Scale score (FSS)
Change in FSS survey question mean scores, scores range from 1-7, lower is better.
Measured: Baseline to 6 months
Fatigue Severity Scale score (FSS)
Change in FSS survey question mean scores, scores range from 1-7, lower is better.
Measured: Baseline to 12 months
Fatigue Severity Scale score (FSS)
Change in FSS survey question mean scores, scores range from 1-7, lower is better.
Measured: Baseline to 18 months
Fatigue Severity Scale score (FSS)
Change in FSS survey question mean scores, scores range from 1-7, lower is better.
Measured: Baseline to 24 months
Brain volume as measured by non contrast magnetic resonance imaging (MRI)
Change in MRI grey matter brain volume, more is better
Measured: baseline to 24 months
Brain lesions as measured by non contrast magnetic resonance imaging (MRI)
Change in inflammatory lesions numbers as measured by non contrast brain MRI, fewer is better
Measured: baseline to 24 months
Timed 25 foot walk test
seconds required to walk 25 feet, lower is better
Measured: baseline to 3 months
Timed 25 foot walk test
seconds required to walk 25 feet, lower is better
Measured: baseline to 24 months
9 Hole peg board test
seconds require to move 9 pegs to various locations on a peg board, fewer seconds is better
Measured: baseline to 3 months
9 Hole peg board test
seconds require to move 9 pegs to various locations on a peg board, fewer seconds is better
Measured: baseline to 24 months
Low contrast visual acuity
A measure of best corrected vision, measure is log minimal angle of resolution at 2.5% contrast. Lower number is better.
Measured: baseline to 3 months
Low contrast visual acuity
A measure of best corrected vision, measure is log minimal angle of resolution at 2.5% contrast. Lower number is better.
Measured: baseline to 24 months
Dietary History Questionnaire IIi
Change in dietary intake measured by survey questions
Measured: baseline to 12 months
Dietary History Questionnaire IIi
Change in dietary intake measured by survey questions
Measured: baseline to 3 months
Critical flicker fusion
change in The herz at which a flickering light is seen as non-flickering as measured by herz
Measured: baseline to 3 months
Critical flicker fusion
change in The herz at which a flickering light is seen as non-flickering as measured by herz
Measured: baseline to 24 months
Ocular Coherence tomography
Measure of optic nerve and retina depths using infrared light technology
Measured: baseline
Ocular Coherence tomography
change in the Measure of optic nerve and retina depths using infrared light technology
Measured: baseline to 3 months
Ocular Coherence tomography
change in the Measure of optic nerve and retina depths using infrared light technology
Measured: baseline to 24 months
Neurofilament light chain
blood biomarker of neuroaxonal (brain) damage
Measured: baseline to 3 months
Neurofilament light chain
blood biomarker of neuroaxonal (brain) damage
Measured: 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.
Measured: baseline to 12 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.
Measured: baseline to 18 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.
Measured: baseline to 24 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2021
- Study start10 Feb 2022
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Multiple Sclerosis, Relapsing-RemittingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled study design
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 162 participants (actual)
Sponsor and investigators
- Lead sponsor
- Terry L. Wahls
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Terry L. Wahls, University of Iowa
- Investigators
- Terry L Wahls, MD, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05007483
- Sponsor's protocol ID
- 202104639
- Acronym
- EDQ
- Status last verified
- Sep 2026
- First submitted
- 9 Aug 2021
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data that has been published will be shared if requested by a scientist conducting a PROSPERO registered meta-analyses who has signed a data use agreement with the University of Iowa Department of Sponsored Programs.
Publications
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.
PubMed 30736445Wahls 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.
PubMed 29866196Chenard 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.
PubMed 30832289Titcomb 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.
PubMed 32575774Lee 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.
PubMed 28394724Lee 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.
PubMed 32213121Chenard 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.
PubMed 30871265Irish 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.
PubMed 30050374Bisht 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.
PubMed 24476345Shemirani 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.
PubMed 41146285
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Diet on Quality of Life in Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT05007483
- Acronym / sponsor ID
- EDQ / 202104639
- Conditions
- Multiple Sclerosis, Relapsing-Remitting
- Keywords
- dietary, nutrition, fatigue, quality of life
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 162 participants (actual)
- Lead sponsor
- Terry L. WahlsUniversity, hospital or other
- Study start
- 10 Feb 2022 (actual)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 16 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
In the United States, MS affects nearly 1 million people with a 2.8:1 female to male ratio and the highest incidence rates among whites and African Americans. The economic cost of managing MS is substantial. In the U.S., the total medical costs for patients with MS increased from $116 million in 2002 to $198 million in 2013. MS is a chronic, neuroinflammatory, and neurodegenerative disease-causing symptoms of pain, fatigue, and changes in vision, cognition, and movement that greatly reduce quality of life (QoL) and the ability to maintain employment.
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.
The proposed study will consist of study participants attending 3 in-person site visits, months 0, 3, and 24, and online surveys every 3 months (months 0-24).
This study will use a randomized single-blind controlled design to test the short-term (6 months) and long-term (an additional 18 months) impact of the intervention diets on symptoms of MS including QoL and related outcomes stated above. We will use a fourteen-day run-in period to identify participants who are most likely to be successful in completing study procedures; this process has been effective in our previous studies. Participants who successfully complete all baseline self-reported outcomes and follow all study procedures during the seven-day run-in period will be scheduled for an on-site baseline visit for randomization to one of three diets (time restricted olive oil based (TROO) ketogenic and modified Paleolithic elimination and Dietary Guidelines for America).
On-site study visits will include blood draws, motor, cognitive, vision function assessments, and MRI. Motor assessments will include a 6-minute walk test, 25-foot walk test, 9-hole pegboard to test hand function, symbol digit exercise to test thinking functions, and critical flicker fusion test, ocular coherence tomography and low contrast vision sensitivity to test vision. The study participant will be escorted to the MRI unit to complete a non-contrast MRI of the brain. At the baseline visit, participants will be randomized. Participants assigned to the intervention diets will be given intervention specific educational materials including shopping lists, example menus and recipes, and the study supplements. Study participants randomized to the dietary guidelines for Americans diet will receive emails and/or text messages (approximately 3-6 weeks) to receive resources with websites for the Dietary Guidelines of America, and recent multiple sclerosis-related research that does not involve diet.
Study team will provide fish oil, essential fatty acids, and phosphatidylcholine to the two intervention groups only. The participant will be scheduled for a Zoom video conference meeting with the assigned registered dietitian to review the assigned study diet.
In addition, subjects will collect saliva specimens for microbiome analysis at each of the 3 site study visits (months 0, 3 and 24).
Dietary History Questionnaire III will be completed at months 0, 3, 12 and 24 and will be used to assess adherence to the assigned dietary pattern.
The online questionnaires sent to participants every 3 months will also be used to track supplement intake, medication use, and details about health \& life events, MS symptoms, fatigue, quality of life, doctor's appointment, and side effects they may be experiencing.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Randomized controlled study design
| Arm | Type | Receives |
|---|---|---|
| Group 1 (Modified paleolithic elimination diet). | Experimental | Dietary Supplement: BodyBio Balance Oil, Dietary Supplement: Kirunal Fish Oil, Dietary Supplement: BodyBio PC, Behavioral: Modified Paleolithic Elimination dietModified paleolithic elimination diet. |
| Group 2 (TROO) | Experimental | Dietary Supplement: BodyBio Balance Oil, Dietary Supplement: Kirunal Fish Oil, Dietary Supplement: BodyBio PC, Behavioral: Time Restricted Olive Oil Based (TROO) Ketogenic DietTime Restricted Olive Oil Based (TROO) Ketogenic Diet |
| Group 3 Control | Active comparator | Behavioral: Usual diet with Dietary Guidelines for Americans Diet informationUsual diet with Dietary Guidelines for Americans Diet information |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BodyBio Balance OilAlso: 1400 mg linoleic acid/350 mg linolenic acidnutraceutical supplement | Dietary supplement | Group 1 (Modified paleolithic elimination diet)., Group 2 (TROO) |
| Kirunal Fish OilAlso: 315 mg eicosapentanoic acid/ 105 mg docosahexaenoic acidnutraceutical supplement | Dietary supplement | Group 1 (Modified paleolithic elimination diet)., Group 2 (TROO) |
| BodyBio PCAlso: 1300 mg phosphatidylcholinenutraceutical supplement | Dietary supplement | Group 1 (Modified paleolithic elimination diet)., Group 2 (TROO) |
| Modified Paleolithic Elimination diet1. 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. | Behavioural | Group 1 (Modified paleolithic elimination diet). |
| Time Restricted Olive Oil Based (TROO) Ketogenic Diet1. 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. | Behavioural | Group 2 (TROO) |
| Usual diet with Dietary Guidelines for Americans Diet information1. 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. | Behavioural | Group 3 Control |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
35 secondary outcomes
Modified Fatigue Impact Scale (MFIS)
Time frame: baseline to 3 months
Modified Fatigue Impact Scale (MFIS)
Time frame: baseline to 6 months
Modified Fatigue Impact Scale (MFIS)
Time frame: baseline to 12 months
Modified Fatigue Impact Scale (MFIS)
Time frame: baseline to 18 months
Modified Fatigue Impact Scale (MFIS)
Time frame: baseline to 24 months
Hospital Anxiety Depression Scale (HADS)
Time frame: baseline to 3 months
Hospital Anxiety Depression Scale (HADS)
Time frame: baseline to 6 months
Hospital Anxiety Depression Scale (HADS)
Time frame: baseline to 12 months
Hospital Anxiety Depression Scale (HADS)
Time frame: baseline to 18 months
Hospital Anxiety Depression Scale (HADS)
Time frame: baseline to 24 months
Fatigue Severity Scale score (FSS)
Time frame: Baseline to 3 months
Fatigue Severity Scale score (FSS)
Time frame: Baseline to 6 months
Fatigue Severity Scale score (FSS)
Time frame: Baseline to 12 months
Fatigue Severity Scale score (FSS)
Time frame: Baseline to 18 months
Fatigue Severity Scale score (FSS)
Time frame: Baseline to 24 months
Brain volume as measured by non contrast magnetic resonance imaging (MRI)
Time frame: baseline to 24 months
Brain lesions as measured by non contrast magnetic resonance imaging (MRI)
Time frame: baseline to 24 months
Timed 25 foot walk test
Time frame: baseline to 3 months
Timed 25 foot walk test
Time frame: baseline to 24 months
9 Hole peg board test
Time frame: baseline to 3 months
9 Hole peg board test
Time frame: baseline to 24 months
Low contrast visual acuity
Time frame: baseline to 3 months
Low contrast visual acuity
Time frame: baseline to 24 months
Dietary History Questionnaire IIi
Time frame: baseline to 12 months
Dietary History Questionnaire IIi
Time frame: baseline to 3 months
Critical flicker fusion
Time frame: baseline to 3 months
Critical flicker fusion
Time frame: baseline to 24 months
Ocular Coherence tomography
Time frame: baseline
Ocular Coherence tomography
Time frame: baseline to 3 months
Ocular Coherence tomography
Time frame: baseline to 24 months
Neurofilament light chain
Time frame: baseline to 3 months
Neurofilament light chain
Time frame: baseline to 24 months
Multiple Sclerosis 54 Quality of Life Physical Health (MS 54 QoL PH)
Time frame: baseline to 12 Months
Multiple Sclerosis 54 Quality of Life Physical Health (MS 54 QoL PH)
Time frame: baseline to 18 Months
Multiple Sclerosis 54 Quality of Life Physical Health (MS 54 QoL PH)
Time frame: baseline to 24 Months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2026.
- Results publication: PubMed 30736445Wahls 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.
- Results publication: PubMed 29866196Wahls 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.
- Results publication: PubMed 30832289Chenard 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.
- Results publication: PubMed 32575774Titcomb 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.
- Results publication: PubMed 28394724Lee 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.
- Results publication: PubMed 32213121Lee 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.
- Results publication: PubMed 30871265Chenard 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.
- Results publication: PubMed 30050374Irish 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.
- Results publication: PubMed 24476345Bisht 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.
- Derived from this study: PubMed 41146285Shemirani 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.
- Individual participant dataSharing planned: Yes. Data that has been published will be shared if requested by a scientist conducting a PROSPERO registered meta-analyses who has signed a data use agreement with the University of Iowa Department of Sponsored Programs.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Terry L Wahls, MD principal investigator
University of Iowa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BodyBio Balance Oil, Kirunal Fish Oil and BodyBio PC in people with Multiple Sclerosis, Relapsing-Remitting, run by Terry L. Wahls at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Multiple Sclerosis 54 Quality of Life Mental Health (MS 54 QoL MH) (time frame: baseline to 3 Months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05007483, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2026.