Efficacy of Diet on Quality of Life in Multiple Sclerosis
- Conditions
- Multiple Sclerosis, Relapsing-Remitting
- Interventions
- Dietary Supplement: BodyBio Balance OilBehavioral: Usual diet with Dietary Guidelines for Americans Diet informationDietary Supplement: Kirunal Fish OilDietary Supplement: BodyBio PCBehavioral: Modified Paleolithic Elimination dietBehavioral: Time Restricted Olive Oil Based (TROO) Ketogenic Diet
- Registration Number
- NCT05007483
- Lead Sponsor
- Terry L. Wahls
- 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.
- 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 2 site study visits (month 0 and 24).
24-hour dietary recalls will be collected by a study registered dietitian (RD) (who did not provide training on the respective participants assigned study diet) on three non-consecutive days at baseline, and one per month, at months 10-12, and 22-24. Participants will be given a 3-month window to complete dietary recalls in the event of scheduling conflicts. Participants will be instructed to record key study diet components each day using a study specific questionnaire in the study related (MyCap) application on their smart device.
The online questionnaires sent to participants every 2 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 162
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group 1 (Modified paleolithic elimination diet). BodyBio Balance Oil Modified paleolithic elimination diet. Group 1 (Modified paleolithic elimination diet). Kirunal Fish Oil Modified paleolithic elimination diet. Group 1 (Modified paleolithic elimination diet). BodyBio PC Modified paleolithic elimination diet. Group 2 (TROO) BodyBio Balance Oil Time Restricted Olive Oil Based (TROO) Ketogenic Diet Group 2 (TROO) BodyBio PC Time Restricted Olive Oil Based (TROO) Ketogenic Diet Group 1 (Modified paleolithic elimination diet). Modified Paleolithic Elimination diet Modified paleolithic elimination diet. Group 2 (TROO) Time Restricted Olive Oil Based (TROO) Ketogenic Diet Time Restricted Olive Oil Based (TROO) Ketogenic Diet Group 2 (TROO) Kirunal Fish Oil Time Restricted Olive Oil Based (TROO) Ketogenic Diet Group 3 Control Usual diet with Dietary Guidelines for Americans Diet information Usual diet with Dietary Guidelines for Americans Diet information
- Primary Outcome Measures
Name Time Method Multiple Sclerosis 54 Quality of Life Mental Health (MS 54 QoL MH) 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) baseline to 24 Months Change in (MS 54 QoL PH) survey questions mean scores, range 0-100, higher number is better.
- Secondary Outcome Measures
Name Time Method Modified Fatigue Impact Scale (MFIS) baseline to 24 months Change in MFIS survey questions, scores range from 0-84, lower score is better.
9 Hole peg board test baseline to 24 months seconds require to move 9 pegs to various locations on a peg board, fewer seconds is better
Hospital Anxiety Depression Scale (HADS) 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
Brain volume as measured by non contrast magnetic resonance imaging (MRI) baseline to 24 months Change in MRI grey matter brain volume, more is better
Low contrast visual acuity 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.
Brain lesions as measured by non contrast magnetic resonance imaging (MRI) baseline to 24 months Change in inflammatory lesions numbers as measured by non contrast brain MRI, fewer is better
Timed 25 foot walk test baseline to 24 months seconds required to walk 25 feet, lower is better
Critical flicker fusion baseline to 24 months The herz at which a flickering light is seen as non-flickering as measured by herz
Ocular Coherence tomography baseline Measure of optic nerve and retina depths using infrared light technology
Neurofilament light chain baseline to 24 months blood biomarker of neuroaxonal (brain) damage
Fatigue Severity Scale score (FSS) Baseline to 24 months Change in FSS survey question mean scores, scores range from 1-7, lower is better.
24 hour dietary intake recalls baseline to 24 months Change in dietary intake measured by dietary interview conducted via telephone call; more nutrients meeting recommended dietary allowance is better.
Trial Locations
- Locations (1)
Univeristy of Iowa
🇺🇸Iowa City, Iowa, United States