Association of serum homocysteine, folate, and vitamin B12 and mood following the Swank and Wahls elimination dietary interventions in relapsing-remitting multiple sclerosis: Secondary analysis of the WAVES trial.

BACKGROUND: Depression and anxiety are common psychiatric comorbidities among people with multiple sclerosis (MS). Emerging data suggest abnormal serum homocysteine, vitamin B12, and folate levels in people with MS, which are related to a range of neurological disorders, including mood and mental illnesses. Evidence suggests that dietary interventions could affect mood disorders via several pathways. This study aimed to evaluate the impact of the low-saturated fat (Swank) and modified Paleolithic elimination (Wahls) diets, along with a supplement regimen, on mood as assessed by Hospital Anxiety and Depression Scale (HADS), and Mental Health Inventory (MHI). The secondary objective was to identify changes in serum levels of homocysteine, folate, and vitamin B12 and the association and mediation effects between their changes and HADS and MHI scores and their subscales among people with relapsing-remitting MS (RRMS). METHODS: In a previously conducted randomized parallel-arm trial, participants with RRMS (n = 77) were randomly allocated to either the Swank or Wahls diets at baseline and followed for 24 weeks. Blood was drawn at four study visits spaced 12 weeks apart: (1) run-in, (2) baseline, (3) 12 weeks, and (4) 24 weeks. Serum vitamin B12, folate, and homocysteine were analyzed. HADS and MHI questionnaires were also completed by participants at the four study visits to assess symptoms of depression and anxiety, behavioral control and positive affect respectively. RESULTS: Significant improvement in severity of depression (HADS-D) and anxiety (HADS-A) symptoms, MHI total, and MHI subscores were seen at 12 and 24 weeks in each diet group. Further, a significant within-group reduction in serum homocysteine and a significant increase in serum vitamin B12 level were observed in both groups at 12 and 24 weeks compared to corresponding baseline values (p ≤ 0.05 for all). All participants exceeded the analytical maximum threshold for folate of 20 nmol/L at 12 and 24 weeks. Changes in serum levels of homocysteine and vitamin B12 were not associated with and did not mediate changes in HADS depression, anxiety, MHI total and four subscales scores (p > 0.05). CONCLUSION: Participants on both Swank and Wahls dietary interventions, including folate and vitamin B12 supplements, showed significant improvement in mood. However, the favorable effects of both diets on mood were not associated with or mediated by the effect of the diets on serum levels of homocysteine, folate, and vitamin B12 (p > 0.05).

Change in Micronutrient Intake among People with Relapsing-Remitting Multiple Sclerosis Adapting the Swank and Wahls Diets: An Analysis of Weighed Food Records.

The low-saturated fat (Swank) and modified Paleolithic elimination (Wahls) diets have shown promise for MS symptoms; however, due to their restriction of specific foods, inadequate intake of micronutrients is concerning. Therefore, as part of a randomized trial, weighed food records were collected on three consecutive days and were used to evaluate the intake of micronutrients among people with relapsing remitting MS adapting these diets. After randomization to either the Swank or Wahls diets, diet education and support was provided by registered dietitians at baseline and throughout the first 12 weeks of the intervention. Usual intake of each micronutrient was estimated and then evaluated with the EAR-cut point method. At 12 weeks, the Swank group had significant reductions in the proportion with inadequate intake from food for vitamins C, D, and E, while the Wahls group had significant reductions for magnesium and vitamins A, C, D, and E. However, the proportion with inadequate intake significantly increased for calcium, thiamin, and vitamin B12 in the Wahls group and for vitamin A in the Swank group. Inclusion of intake from supplements reduced the proportion with inadequate intake for all micronutrients except calcium among the Wahls group but increased the proportion with excessive intake for vitamin D and niacin among both groups and magnesium among the Swank group. Both diets, especially when including intake from supplements, are associated with reduced inadequate intake compared to the normal diet of people with relapsing remitting MS.

Eating Pattern and Nutritional Risks among People with Multiple Sclerosis Following a Modified Paleolithic Diet.

Preliminary studies suggest that a modified Paleolithic diet may benefit symptoms of fatigue in progressive multiple sclerosis (MS). However, this diet restricts the consumption of eggs, dairy, and gluten-containing grains, which may increase the risk of micronutrient deficiencies. Therefore, we evaluated the nutritional safety of this diet among people with progressive MS. Three nonconsecutive 24-h dietary recalls were collected from (n = 19) progressive MS participants in the final months of a diet intervention study and analyzed using Nutrition Data System for Research (NDSR) software. Food group intake was calculated, and intake of micronutrients was evaluated and compared to individual recommendations using Nutrient Adequacy Ratios (NARs). Blood was drawn at baseline and the end of the study to evaluate biomarker changes. Mean intake of fruits and vegetables exceeded nine servings/day and most participants excluded food groups. The intake of all micronutrients from food were above 100% NAR except for vitamin D (29.6 ± 34.6%), choline (73.2 ± 27.2%), and calcium (60.3 ± 22.8%), and one participant (1/19) exceeded the Tolerable Upper Limit (UL) for zinc, one (1/19) for vitamin A, and 37% (7/19) exceeded the chronic disease risk reduction (CDRR) for sodium. When intake from supplements was included in the analysis, several individuals exceeded ULs for magnesium (5/19), zinc (2/19), sodium (7/19), and vitamins A (2/19), D (9/19), C (1/19), B6 (3/19), and niacin (10/19). Serum values of vitamins D, B12, K1, K2, and folate significantly increased compared to respective baseline values, while homocysteine and magnesium values were significantly lower at 12 months. Calcium and vitamin A serum levels did not change. This modified Paleolithic diet is associated with minimal nutritional risks. However, excessive intake from supplements may be of concern.

Nutrient Composition Comparison between the Low Saturated Fat Swank Diet for Multiple Sclerosis and Healthy U.S.-Style Eating Pattern.

Multiple sclerosis (MS) is an incurable degenerative disease that attacks the central nervous system. Roy Swank proposed a low saturated fat diet to treat MS around 1950 and showed delayed disease progression in his patients. However, there is insufficient evidence to recommend this diet for MS and default dietary recommendations are the Dietary Guidelines for Americans (DGA). This study assessed the nutritional adequacy of seven-day menus developed by Swank and their compliance with the DGA; menus were modeled for comparison with the DGA Healthy US-Style Eating Pattern (HEP) for males and females 31⁻50 years. Swank recommended dietary supplements corrected menu shortfalls in vitamins D, E, calcium, folate and iron but not dietary fiber, potassium and choline. Healthy Eating Index-2015 score for Swank menus (93.2/100) indicated good compliance with the DGA. Nutritional adequacy of the Swank modeled diet was similar to HEP for 17 vitamins and minerals (Mean Adequacy Ratios ≥94%) with similar shortfall nutrients except magnesium (HEP males) and dietary fiber (Swank males). Alternate Healthy Eating Index-2010 scores for Swank male (90/110) and female (88/110) model diets were similar to HEP. Swank menus have similar nutritional adequacy as HEP. Inclusion of foods high in dietary fiber, potassium and choline may be advised as well as selection of foods to reduce sodium below the Tolerable Upper Intake Level.

Nutrient Composition Comparison between a Modified Paleolithic Diet for Multiple Sclerosis and the Recommended Healthy U.S.-Style Eating Pattern.

Multiple sclerosis (MS) is a demyelinating disease that attacks the central nervous system. Evidence-based dietary guidelines do not exist for MS; the default advice is to follow the Dietary Guidelines for Americans (DGA). A modified Paleolithic Wahls Elimination (WahlsElim) diet promoted for MS excludes grains and dairy and encourages 9+ cups fruits and vegetables (F/V) and saturated fat for cooking. This study evaluated the nutritional adequacy of seven-day menus and modeled them with varying amounts of F/V for comparison with the DGA Healthy US-Style Eating Pattern (HEP) for ages 31⁻50 years. WahlsElim menus had low added sugar and glycemic index. Nutritional adequacy of the menus and modeled versions were similar to HEP for 17 vitamins and minerals (mean adequacy ratio ≥92%). Nutrient shortfalls for the modeled diet with 60% F/V were identical to HEP for vitamin D, iron (females), magnesium (marginally males), choline and potassium; this modeled diet was also low in dietary fiber and calcium but met vitamin E requirements while HEP did not. WahlsElim-prescribed supplements corrected vitamin D and magnesium shortfalls; careful selection of foods are needed to meet requirements of other shortfall nutrients and reduce saturated fat and sodium. Doctors should monitor nutritional status, supplement doses, and possible contraindications to high vitamin K intake in individuals following the WahlsElim diet.

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

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.

Multimodal intervention improves fatigue and quality of life in subjects with progressive multiple sclerosis: a pilot study.

BACKGROUND: Fatigue is a disabling symptom of multiple sclerosis (MS) and reduces quality of life. The aim of this study was to investigate the effects of a multimodal intervention, including a modified Paleolithic diet, nutritional supplements, stretching, strengthening exercises with electrical stimulation of trunk and lower limb muscles, and stress management on perceived fatigue and quality of life of persons with progressive MS. METHODS: Twenty subjects with progressive MS and average Expanded Disability Status Scale (EDSS) score of 6.2 (range: 3.5-8.0) participated in the 12-month phase of the study. Assessments were completed at baseline and at 3 months, 6 months, 9 months, and 12 months. Safety analyses were based on monthly side effects questionnaires and blood analyses at 1 month, 3 months, 6 months, 9 months, and 12 months. RESULTS: Subjects showed good adherence (assessed from subjects' daily logs) with this intervention and did not report any serious side effects. Fatigue Severity Scale (FSS) and Performance Scales-fatigue subscale scores decreased in 12 months (P<0.0005). Average FSS scores of eleven subjects showed clinically significant reduction (more than two points, high response) at 3 months, and this improvement was sustained until 12 months. Remaining subjects (n=9, low responders) either showed inconsistent or less than one point decrease in average FSS scores in the 12 months. Energy and general health scores of RAND 36-item Health Survey (Short Form-36) increased during the study (P<0.05). Decrease in FSS scores during the 12 months was associated with shorter disease duration (r=0.511, P=0.011), and lower baseline Patient Determined Disease Steps score (r s=0.563, P=0.005) and EDSS scores (r s=0.501, P=0.012). Compared to low responders, high responders had lower level of physical disability (P< 0.05) and lower intake of gluten, dairy products, and eggs (P=0.036) at baseline. High responders undertook longer duration of massage and stretches per muscle (P<0.05) in 12 months. CONCLUSION: A multimodal intervention may reduce fatigue and improve quality of life of subjects with progressive MS. Larger randomized controlled trials with blinded raters are needed to prove efficacy of this intervention on MS-related fatigue.

A multimodal intervention for patients with secondary progressive multiple sclerosis: feasibility and effect on fatigue.

BACKGROUND: Multiple sclerosis is an autoimmune disease influenced by environmental factors. OBJECTIVES: The feasibility of a multimodal intervention and its effect on perceived fatigue in patients with secondary progressive multiple sclerosis were assessed. DESIGN/SETTING: This was a single-arm, open-label intervention study in an outpatient setting. INTERVENTIONS: A multimodal intervention including a modified paleolithic diet with supplements, stretching, strengthening exercises with electrical stimulation of trunk and lower limb muscles, meditation, and massage was used. OUTCOME MEASURES: Adherence to each component of the intervention was calculated using daily logs. Side-effects were assessed from a monthly questionnaire and blood analyses. Fatigue was assessed using the Fatigue Severity Scale (FSS). Data were collected at baseline and months 1, 2, 3, 6, 9, and 12. RESULTS: Ten (10) of 13 subjects who were enrolled in a 2-week run-in phase were eligible to continue in the 12-month main study. Of those 10 subjects, 8 completed the study and 6 subjects fully adhered to the study intervention for 12 months. Over a 12-month period, average adherence to diet exceeded 90% of days, and to exercise/muscle stimulation exceeded 75% of days. Nutritional supplements intake varied among and within subjects. Group daily average duration of meditation was 13.3 minutes and of massage was 7.2 minutes. No adverse side-effects were reported. Group average FSS scores decreased from 5.7 at baseline to 3.32 (p=0.0008) at 12 months. CONCLUSIONS: In this small, uncontrolled pilot study, there was a significant improvement in fatigue in those who completed the study. Given the small sample size and completer rate, further evaluation of this multimodal therapy is warranted.

Rehabilitation with neuromuscular electrical stimulation leads to functional gains in ambulation in patients with secondary progressive and primary progressive multiple sclerosis: a case series report.

BACKGROUND: Gait disability in patients with secondary progressive multiple sclerosis (SPMS) or primary progressive multiple sclerosis (PPMS) rarely improves. PRIMARY STUDY OBJECTIVE: This article reports on a case series of patients with SPMS and PPMS who were treated using neuromuscular electrical stimulation (NMES), a well-tolerated physical therapy (PT) treatment modality used to aid musculoskeletal recovery, coupled with a home-exercise program (HEP) to treat MS-related gait disability. SETTING: The setting for this trial was a PT private practice. PATIENTS: This trial was conducted with patients who had SPMS or PPMS with MS-related gait disability. CASE SERIES DESCRIPTION/INTERVENTION: Between June 2007 and June 2009, a licensed physical therapist (R.D.) used NMES coupled with a HEP to work with patients who had SPMS/PPMS and multiple sclerosis (MS)-related gait disability. All of the cases in which an NMES test session of NMES was conducted were included in the case series. Data regarding MS symptoms, treatment, gait, and function were abstracted from the PT clinic notes. Results of assessment with the expanded Kurtzke Disability Status Scale (EDSS) at presentation and at most recent visit were abstracted from the clinical record by the treating physical therapist (R.D.). CLINICAL OUTCOME/RESULTS: Nine (9) patients (7 with SPMS and 2 with PPMS) met inclusion criteria for review. Mean of years of diagnosis was 10.4 (range, 4-15), and mean EDSS score at presentation was 5.9 (range, 4.5-6.5). Mean of days of NMES was 140 (range, 22-495). Mean EDSS scores improved by 0.78 (range, 0-2.0). CONCLUSIONS: NMES, an approved Food and Drug Administration treatment modality for muscle spasm, muscle pain, and disuse atrophy-all of which are commonly present in patients with gait disability associated with SPMS and PPMS-was associated with measurable gains in ambulatory function. Additional studies are warranted.