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

Figures & data

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.

Table 1 Baseline characteristics of subjects in control and MPDI groups

Characteristic	Control group	MPDI group	Significant difference p-value (ITT)	Comparison of healthy adulta
Sex
Women:men	8:1	7:1
Age (years)
Mean ± SD	37.1±3.7	35.4 ±5.7	0.23 (0.32)
FSS-9
Mean ± SD	4.0±1.2	4.2 ±1.6	0.38 (0.47)	2.3±0.7^Citation70
METs
Mean ± SD	5.8±2.5	6.1 ±2.4	0.39 (0.20)	8.2±1.2^Citation71
25-FW (s)
Mean ± SD	4.7±0.5	4.7 ±0.7	0.48 (0.29)	3.7±1.7^Citation72
9-HPT (dominant)
Mean ± SD	19.6±2.0	21.0 ±3.9	0.19 (0.34)	18.7±1.7^Citation73
9-HPT (nondominant)
Mean ± SD	20.4±3.6	24.4 ±4.5	0.03 (0.10)	20.1±2.0^Citation73
PASAT (of 60)
Mean ± SD	53.2±5.0	44.9 ±4.5	0.001 (0.001)	50.4±9.7^Citation74
6-MW (m)
Mean ± SD	532.9±56.1	570.1 ±56.0	0.10 (0.04)
MSQOL-54 (physical)
Mean ± SD	68.1±11.8	67.3 ±15.2	0.45 (0.45)
MSQOL-54 (mental)
Mean ± SD	65.5±11.5	74.5 ±10.8	0.06 (0.06)
B-1 (thiamine) (nmol/L)
Mean ± SD	129.5±36.0	150.8 ±28.7	0.11 (0.18)	78–185
B-9 (folate) (ng/mL)
Mean ± SD	13.1±5.9	16.7 ±3.0	0.11 (0.19)
B-12 (cobalamin) (pg/mL)
Mean ± SD	498.0±153.0	663.1 ±183.6	0.03 (0.02)	180–914
K (pg/mL)
Mean ± SD	1758.3±910.6	1643.4 ±863.3	0.40 (0.28)
HCY (μmol/L)
Mean ± SD	9.3±3.7 9.4	±1.8	0.47 (0.37)	<15.4
Hs-CRP (mg/L)
Mean ± SD	1.4±1.2	4.4 ±4.3	0.03 (0.04)	0.1–5

Notes:

a Normative laboratory values are specific for methodologies/instrumentation; between laboratories, values can differ; values were obtained from provided citations or (for serum measures) our testing facility.

Abbreviations: MPDI, modified Paleolithic dietary intervention; ITT, intention-to-treat; SD, standard deviation; FSS, Fatigue Severity Scale; METs, Metabolic Equivalent Tasks; 25-FW, 25-Foot Walk; 6-MW, 6-minute walk; PASAT, Paced Audio Serial Addition Test; 9-HPT, 9-Hole Peg Test; Hs-CRP, high-sensitivity C-reactive protein; HCY, homocysteine; MSQOL, Multiple Sclerosis Quality of Life.

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.

Figure S1 Food Log.

Abbreviations: C, cup; svg, serving; tbs, tablespoon.

Figure S2 Food Diary.

Table S1 Adherence

Subject	Gluten grains (baseline)	1 month	Postprotocol	Dairy (baseline)	1 month	Postprotocol
C1	6.62	1.54	2.54	1.07	0.18	1.42
C2	3.50	8.86	3.44	1.18	0.07	0.12
C3	5.06	5.21	3.05	1.30	1.34	1.76
C4	0.00	1.18	0.00	0.00	0.01	0.00
C5	1.16	4.22	7.04	0.67	2.23	2.32
C6	6.14	3.96	13.63	0.17	1.40	1.09
C7	13.30	7.93	2.57	1.42	1.59	0.47
C8	1.97	1.85	4.12	0.98	0.71	0.01
C9	5.91	0.10	13.10	1.13	0.26	1.02
Mean	4.85	3.87	5.50	0.88	0.87	0.91
SE	1.40	1.08	1.70	0.18	0.28	0.29
D1	4.48	0.00	0.00	0.98	0.00	0.00
D2	5.25	0.00	0.00	2.54	0.00	0.00
D3	3.14	0.00	0.00	11.05	0.00	0.00
D4	6.66	0.00	0.00	1.46	0.00	0.00
D5	3.23	0.00	0.00	0.46	0.00	0.00
D6	1.32	0.00	0.00	1.10	0.00	0.00
D7	7.44	0.00	0.00	1.38	0.00	0.00
D8	4.89	0.00	0.00	0.71	0.00	0.00
Mean	4.55	0.00	0.00	2.46	0.00	0.00
SE	0.75	0.00	0.00	1.33	0.00	0.00

Notes: Total consumed gluten-containing grains and dairy reported by individual control (C1–C9) and MPDI (D1–D8) subjects from baseline, 1 month, and postprotocol ASA-24 recalls. Values in ounce equivalents for gluten-containing grains and cup equivalents for dairy were collected from Individual Foods and Pyramid Equivalents (INFMYPHEI) and Daily Total Pyramid Equivalents (TNMYPHEI) batched ASA-24 reports. Ounce equivalents are quantities of foods that count as one ounce of that food toward daily recommended intake (eg, one slice of bread, one cup of ready-to-eat cereal, or half cup of cooked rice).

Abbreviations: MPDI, modified Paleolithic dietary intervention; SE, standard error; ASA-24, Automated Self-Administered 24-hour dietary recall.

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