NCT05007483

Efficacy of Diet on Quality of Life in Multiple Sclerosis

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 162 (actual)
• Sponsor: Terry L. Wahls · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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.

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

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	BodyBio Balance Oil	nutraceutical supplement
DIETARY_SUPPLEMENT	Kirunal Fish Oil	nutraceutical supplement
DIETARY_SUPPLEMENT	BodyBio PC	nutraceutical supplement
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.
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.
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.

Timeline

• Start date: 2022-02-10
• Primary completion: 2026-09-01
• Completion: 2026-12-01
• First posted: 2021-08-16
• Last updated: 2025-09-12

Locations

1 site across 1 country: United States