Randomized control trial evaluation of a modified Paleolithic dietary intervention in the treatment of relapsing-remitting multiple sclerosis: a pilot study

Abstract

Background/objective: A Paleolithic diet may improve fatigue and quality of life in progressive multiple sclerosis (MS) patients, but past research has evaluated the effects of this dietary intervention in combination with other treatments such as exercise. Thus, the purpose of this pilot study was to evaluate a modified Paleolithic dietary intervention (MPDI) in the treatment of fatigue and other symptoms in relapsing-remitting MS (RRMS).

Methods: We measured the effects of a MPDI in 17 individuals with RRMS. Of 34 subjects randomly assigned to control (maintain usual diet) and intervention (MPDI) groups, nine subjects (one man) completed the control group and eight subjects (one man) completed the MPDI.

Results: Significant improvements were seen in Fatigue Severity Scale score and also in Multiple Sclerosis Quality of Life-54 and time to complete (dominant hand) 9-Hole Peg Test from baseline in MPDI subjects compared to controls. Increased vitamin K serum levels were also observed in MPDI subjects postprotocol compared to controls.

Conclusion: A Paleolithic diet may be useful in the treatment and management of MS, by reducing perceived fatigue, increasing mental and physical quality of life, increasing exercise capacity, and improving hand and leg function. By increasing vitamin K serum levels, the MPDI may also reduce inflammation.

Keywords: alternative medicine; complementary medicine; diet therapy; fatigue; gluten-free; nutrition therapy; quality of life.

Figure 1

Study flowchart. Notes: Eighty-two individuals were screened for eligibility using a simple phone script. Seventy-one individuals were found eligible to participate; of these, thirty-one consented and completed baseline study measurements. Seventeen individuals were allocated to the MPDI, sixteen trained, and ten completed all study procedures. Two subjects were removed from the analysis due to nonadherence to the MPDI. Seventeen individuals were allocated to the control group, fifteen trained, and nine completed all study procedures.

Figure 2

Mean FSS scores at baseline and postprotocol in control and MPDI groups (A). Each bar represents the mean score from the nine questions of the FSS for each subject group (abscissa) at baseline (black bars) and postprotocol (crosshatch bars). Error bars indicate ± SE. Changes in FSS scores of individual control (C1–C9) and MPDI (D1–D8) subjects from baseline to postprotocol (B); * denotes significant difference. Abbreviations: MPDI, modified Paleolithic dietary intervention; FSS, Fatigue Severity Scale; SE, standard error.

Figure 3

Mean changes in MSQOL-M (A) and MSQOL-P (C). Each bar represents the mean score for the MSQOL mental (A) and physical (C) health domains for subject groups (abscissa) at baseline (black bars) and postprotocol (crosshatch bars). Error bars indicate ± SE. Changes in MSQOL scores of individual control (C1–C9) and MPDI (D1–D8) subjects from baseline to postprotocol for mental (B) and physical (D) health domains. * denotes significant difference. Abbreviations: MPDI, modified Paleolithic dietary intervention; MSQOL, Multiple Sclerosis Quality of Life; MSQOL-M, MSQOL mental; MSQOL-P, MSQOL physical; SE, standard error.

Figure 4

Average changes in motor tests for each group: dominant hand 9-HPT (A), nondominant hand 9-HPT (B), 25-FW (C), and 6-MW (D). Notes: Each bar represents the mean time (A–C), or distance walked (D), for the control or MPDI groups in the specified test at baseline and postprotocol. Average times in two 9-HPT trials with each hand and two 25-FW tests were used. Error bars indicate ± SE. Abbreviations: SE, standard error; 9-HPT, 9-Hole Peg Test; 25-FW, 25-Foot Walk; 6-MW, 6-minute walk; MPDI, modified Paleolithic dietary intervention.

Figure 5

Average changes in blood serum concentrations of vitamins K (A), B-1 (B), B-9 (C), B-12 (D), Hs-CRP (E), and HCY (F). Notes: Each bar represents the mean serum concentration of the specified measure for the control or MPDI group at baseline and postprotocol. Error bars indicate ± SE. The dashed lines represent presumptive upper and lower serum measure limits of healthy adults (normative laboratory values reported by testing facility). Abbreviations: MPDI, modified Paleolithic dietary intervention; SE, standard error; HCY, homocysteine.