Impact of the Swank and Wahls elimination dietary interventions on fatigue and quality of life in relapsing-remitting multiple sclerosis: The WAVES randomized parallel-arm clinical trial

Terry L Wahls, Tyler J Titcomb, Babita Bisht, Patrick Ten Eyck, Linda M Rubenstein, Lucas J Carr, Warren G Darling, Karin F Hoth, John Kamholz, Linda G Snetselaar, Terry L Wahls, Tyler J Titcomb, Babita Bisht, Patrick Ten Eyck, Linda M Rubenstein, Lucas J Carr, Warren G Darling, Karin F Hoth, John Kamholz, Linda G Snetselaar

Abstract

Objective: To compare the effect of the modified Paleolithic elimination (Wahls) and low-saturated fat (Swank) diets in relapsing-remitting MS (RRMS).

Methods: Individuals (n = 87) with RRMS were randomized to the Swank or Wahls diets in a parallel group clinical trial consisting of four timepoints: 1) run-in, 2) baseline, 3) 12-weeks, and 4) 24-weeks.

Results: 77 participants completed 12 weeks and 72 completed 24 weeks. The 12-week change from baseline in fatigue was -0.94 ± 0.18 (FSS) and -9.87 ± 1.93 (MFIS; both p < 0.0001) for Swank, and -0.71 ± 0.24 (FSS; p = 0.004) and -14.41 ± 2.22 (MFIS; p ≤ 0.0001) for Wahls. Physical MSQoL scores improved by 6.04 ± 2.18 (p = 0.006) for Swank and by 14.5 ± 2.63 (p < 0.0001) for Wahls. Mental MSQoL scores improved by 11.3 ± at 2.79 (p < 0.0001) for Wahls while the Swank did not change (3.85 ± 2.63; p = 0.14). Neither group showed significant changes in 6-minute walking distance at 12 weeks. All outcomes were maintained or further improved at 24 weeks.

Conclusions: Both diets were associated with clinically meaningful within-group reductions in fatigue and improvements in QoL.Trial Registration: Clinicaltrials.gov Identifier: NCT02914964.

Keywords: 6-minute walk test; Multiple sclerosis; fatigue; low-saturated fat diet; paleolithic diet; quality of life.

© The Author(s) 2021.

Figures

Figure 1.
Figure 1.
CONSORT diagram of study recruitment and participant flow. Reasons for ineligibility or exclusion may not add up to value of ineligible or excluded because some participants were found ineligible or were excluded for multiple reasons.
Figure 2.
Figure 2.
Change from baseline for (A) Fatigue Severity Scale (FSS), (B) total Modified Fatigue Impact Scale (MFIS), (C) Multiple Sclerosis Quality of Life-54 (MSQoL-54) mental, (D) MSQoL-54 physical, and (E) 6-minute walk test among study participants with RRMS randomized to either the Swank diet (grey bars) or the Wahls elimination diet (black bars) for 24 weeks. The dashed lines represent thresholds of clinically meaningful changes. Statistical significance determined by generalized linear mixed models, statistical significance is represented by * = p ≤ 0.05, ** = p ≤ 0.01, *** = p ≤ 0.001.

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