Randomized-controlled trial of a modified Mediterranean dietary program for multiple sclerosis: A pilot study

Sand, Ilana Katz; Benn, Emma K. T.; Fabian, Michelle; Fitzgerald, Kathryn C.; Digga, Elise; Deshpande, Richa; Miller, Aaron; Gallo, Samantha; Arab, Lenore

doi:10.1016/j.msard.2019.101403

Cited by 66 publications

(115 citation statements)

References 36 publications

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“…Dietary intake impacts immune profile and function, which includes development of the host immune system, protection against pathogens and maintenance of the immune response 1–3. As a result, researchers have looked toward dietary modification as a way of impacting immune-mediated disorders, such as MS 4–8…”

Section: Introductionmentioning

confidence: 99%

Phase II study of ketogenic diets in relapsing multiple sclerosis: safety, tolerability and potential clinical benefits

Brenton

Lehner-Gulotta

Woolbright

et al. 2022

J Neurol Neurosurg Psychiatry

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BackgroundDietary changes impact human physiology and immune function and have potential as therapeutic strategies.ObjectiveAssess the tolerability of a ketogenic diet (KD) in patients with relapsing multiple sclerosis (MS) and define the impact on laboratory and clinical outcome metrics.MethodsSixty-five subjects with relapsing MS enrolled into a 6-month prospective, intention-to-treat KD intervention. Adherence was monitored with daily urine ketone testing. At baseline, fatigue, depression and quality of life (QoL) scores were obtained in addition to fasting adipokines and MS-related clinical outcome metrics. Baseline metrics were repeated at 3 and/or 6 months on-diet.ResultsEighty-three percent of participants adhered to the KD for the study duration. Subjects exhibited significant reductions in fat mass and showed a nearly 50% decline in self-reported fatigue and depression scores. MS QoL physical health (67±16 vs 79±12, p<0.001) and mental health (71±17 vs 82±11, p<0.001) composite scores increased on-diet. Significant improvements were noted in Expanded Disability Status Scale scores (2.3±0.9 vs 1.9±1.1, p<0.001), 6-minute walk (1631±302 vs 1733±330 ft, p<0.001) and Nine-Hole Peg Test (21.5±3.6 vs 20.3±3.7 s, p<0.001). Serum leptin was lower (25.5±15.7 vs 14.0±11.7 ng/mL, p<0.001) and adiponectin was higher (11.4±7.8 vs 13.5±8.4 µg/mL, p=0.002) on the KD.ConclusionKDs are safe and tolerable over a 6-month study period and yield improvements in body composition, fatigue, depression, QoL, neurological disability and adipose-related inflammation in persons living with relapsing MS.Trial registration informationRegistered on ClinicalTrials.gov under registration number NCT03718247, posted on 24 October 2018. First patient enrolment date: 1 November 2018. Link: https://clinicaltrials.gov/ct2/show/NCT03718247?term=NCT03718247&draw=2&rank=1.

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Section: Introductionmentioning

confidence: 99%

Phase II study of ketogenic diets in relapsing multiple sclerosis: safety, tolerability and potential clinical benefits

Brenton

Lehner-Gulotta

Woolbright

et al. 2022

J Neurol Neurosurg Psychiatry

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“…[30] In the second pilot, conducted by Sand et al, modified MeD reduced fatigue (P = .01), the severity of MS symptoms (P = .023), and disability (P = .01) during six months in 36 enrolled women. [31] The exact mechanism by which MeD may be protective in neurodegenerative disorders is yet unknown. Oxidative stress -as a result of imbalance in pro-oxidant/antioxidant homeostasis -has been implicated in the pathogenesis of MS. [32] Complex phenols and other substances, including vitamin C, vitamin E, and carotenoids may serve as antioxidants and are found in high concentrations in the various forms of the MeD.…”

Section: Discussionmentioning

confidence: 99%

Potential of modified Mediterranean diet to improve quality of life and fatigue severity in multiple sclerosis patients: a single-center randomized controlled trial

Moravejolahkami

Paknahad

Chitsaz

et al. 2020

International Journal of Food Properties

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“…More often than not, studies fall short of their recruitment goals in a specific time frame. [25][26][27][28][29] Occasionally, studies achieve their goal 30 or even surpass the goal 31 suggesting that the recruitment methods were successful.…”

Section: Recruitment Feasibility In Pilot Studies -Stewart Et Almentioning

confidence: 99%

Guidelines for Evaluating the Feasibility of Recruitment in Pilot Studies of Diverse Populations: An Overlooked but Important Component

et al. 2020

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Background: In health disparities research, studies often fall short of their recruitment goals. Conducting a pilot feasibility study of recruitment in which data are collected systematically on recruitment processes can help investigators refine methods for the larger study. However, there are few guidelines for conducting pilot feasibility studies, and recruitment methods are seldom the focus. Feasibility indicators differ from traditional reports of recruitment results by focusing on the extent to which recruitment goals are met.Methods: We present an organizing framework for assessing the feasibility of recruitment that includes eight steps, briefly: 1) specify recruitment goals; 2) specify recruitment processes; 3) establish a tracking system for each individual; 4) establish a tracking database for monitoring processes and results; 5) implement recruitment and track each individual’s progress; 6) summarize recruitment results; 7) calculate and interpret feasibility measures - were goals met; and 8) if goals were not met, utilize tracking data to modify methods for the larger study. We describe methods within each step, with added details for steps 2-5 (the specific processes). The framework draws from a small literature on recruitment feasibility with a focus on health disparities populations. The guidelines blend well-known methods of recruitment with additional information on calculating feasibility indicators.Conclusion: These guidelines provide a first step in thinking systematically about recruitment feasibility, to advance the field of measuring feasibility. Feasibility indicators also can be used to track the effectiveness of innovative recruitment strategies as part of building the science of recruitment, especially in disparities populations. Ethn Dis. 2020; 30(Suppl 2):745-754; doi:10.18865/ed.30.S2.745

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Randomized-controlled trial of a modified Mediterranean dietary program for multiple sclerosis: A pilot study

Cited by 66 publications

References 36 publications

Phase II study of ketogenic diets in relapsing multiple sclerosis: safety, tolerability and potential clinical benefits

Phase II study of ketogenic diets in relapsing multiple sclerosis: safety, tolerability and potential clinical benefits

Potential of modified Mediterranean diet to improve quality of life and fatigue severity in multiple sclerosis patients: a single-center randomized controlled trial

Guidelines for Evaluating the Feasibility of Recruitment in Pilot Studies of Diverse Populations: An Overlooked but Important Component

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