Trial Outcomes & Findings for Evaluation of a Modified Paleolithic Dietary Intervention in the Treatment of Relapsing-Remitting Multiple Sclerosis (NCT NCT02687919)

Last Updated: 2019-08-12

Results Overview

Specific Aims: 1) Test the hypothesis that a modified Paleolithic diet reduces effects of fatigue in subjects with Relapsing-Remitting Multiple Sclerosis (RRMS), compared to controls, in: (a) daily life as measured by the Fatigue Severity Scale (FSS) score. A 9-item sel-report questionnaire related to how fatigue interferes with certain activities and rates its severity, items are scored on a 7 point scale with 1 = strongly disagree and 7= strongly agree. The minimum score is 9 and maximum score is 63. Higher the score indicates greater fatigue severity.

Recruitment status

COMPLETED

Study phase

Target enrollment

31 participants

Primary outcome timeframe

End of Study, measured at 3.5 months; Change from Baseline

Results posted on

2019-08-12

Participant Flow

Participant milestones

Participant milestones
Measure	Modified Paleo Diet Intervention (MPDI) Consumed a modified Paleo diet, described as nine cups of vegetables and some fruits, meat protein including organ meat, and complete abstinence from products containing gluten (wheat, barley, rye, etc.), dairy, potatoes, and legumes (beans, lentils, peanuts, soy, etc.) Modified Paleo diet: Nine cups of vegetables and some fruits, meat protein including organ meat, and complete abstinence from products containing gluten (wheat, barley, rye, etc.), dairy, potatoes, and legumes (beans, lentils, peanuts, soy, etc.)	Usual Care Typical physician recommendations for MS.
Overall Study STARTED	16	15
Overall Study COMPLETED	8	9
Overall Study NOT COMPLETED	8	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Modified Paleo Diet Intervention (MPDI) Consumed a modified Paleo diet, described as nine cups of vegetables and some fruits, meat protein including organ meat, and complete abstinence from products containing gluten (wheat, barley, rye, etc.), dairy, potatoes, and legumes (beans, lentils, peanuts, soy, etc.) Modified Paleo diet: Nine cups of vegetables and some fruits, meat protein including organ meat, and complete abstinence from products containing gluten (wheat, barley, rye, etc.), dairy, potatoes, and legumes (beans, lentils, peanuts, soy, etc.)	Usual Care Typical physician recommendations for MS.
Overall Study Withdrawal by Subject	6	6
Overall Study Protocol Violation	2	0

Baseline Characteristics

One sample from usual care was lost.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Modified Paleo Diet Intervention (MPDI) n=8 Participants Consumed a modified Paleo diet, described as nine cups of vegetables and some fruits, meat protein including organ meat, and complete abstinence from products containing gluten (wheat, barley, rye, etc.), dairy, potatoes, and legumes (beans, lentils, peanuts, soy, etc.) Modified Paleo diet: Nine cups of vegetables and some fruits, meat protein including organ meat, and complete abstinence from products containing gluten (wheat, barley, rye, etc.), dairy, potatoes, and legumes (beans, lentils, peanuts, soy, etc.)	Usual Care n=9 Participants Typical physician recommendations for MS.	Total n=17 Participants Total of all reporting groups
Age, Continuous	35.4 years STANDARD_DEVIATION 5.7 • n=8 Participants	37.1 years STANDARD_DEVIATION 3.7 • n=9 Participants	36.2 years STANDARD_DEVIATION 4.7 • n=17 Participants
Sex: Female, Male Female	7 Participants n=8 Participants	8 Participants n=9 Participants	15 Participants n=17 Participants
Sex: Female, Male Male	1 Participants n=8 Participants	1 Participants n=9 Participants	2 Participants n=17 Participants
Fatigue Severity Scale (FSS)-9	4.2 units on a scale STANDARD_DEVIATION 1.6 • n=8 Participants	4.0 units on a scale STANDARD_DEVIATION 1.2 • n=9 Participants	4.1 units on a scale STANDARD_DEVIATION 1.4 • n=17 Participants
Veterans Specific Activity Questionnaire (VSAQ)	6.1 units on a scale STANDARD_DEVIATION 2.4 • n=8 Participants	5.8 units on a scale STANDARD_DEVIATION 2.5 • n=9 Participants	6.0 units on a scale STANDARD_DEVIATION 2.4 • n=17 Participants
Timed 25-Foot Walk (25-FW)	4.7 seconds STANDARD_DEVIATION 0.7 • n=8 Participants	4.7 seconds STANDARD_DEVIATION 0.5 • n=9 Participants	4.7 seconds STANDARD_DEVIATION 0.6 • n=17 Participants
9-Hole Peg Test (9-HPT) (dominant)	21.0 seconds STANDARD_DEVIATION 3.9 • n=8 Participants	19.6 seconds STANDARD_DEVIATION 2.0 • n=9 Participants	20.3 seconds STANDARD_DEVIATION 3.1 • n=17 Participants
9-Hole Peg Test (9-HPT) (nondominant)	24.4 seconds STANDARD_DEVIATION 4.5 • n=8 Participants	20.4 seconds STANDARD_DEVIATION 3.6 • n=9 Participants	22.4 seconds STANDARD_DEVIATION 4.4 • n=17 Participants
Paced Auditory Serial Addition Test (PASAT)	44.9 units on a scale STANDARD_DEVIATION 4.5 • n=8 Participants	53.2 units on a scale STANDARD_DEVIATION 5.0 • n=9 Participants	49 units on a scale STANDARD_DEVIATION 6.3 • n=17 Participants
6 Minute Walk (6-MW)	570.1 meters STANDARD_DEVIATION 56.0 • n=8 Participants	532.9 meters STANDARD_DEVIATION 56.1 • n=9 Participants	551.5 meters STANDARD_DEVIATION 57.5 • n=17 Participants
Multiple Sclerosis Quality of Life-54 (MSQOL-54) (physical)	67.3 units on a scale STANDARD_DEVIATION 15.2 • n=8 Participants	68.1 units on a scale STANDARD_DEVIATION 11.8 • n=9 Participants	67.7 units on a scale STANDARD_DEVIATION 13.1 • n=17 Participants
Multiple Sclerosis Quality of Life-54 (MSQOL-54) (mental)	74.5 units on a scale STANDARD_DEVIATION 10.8 • n=8 Participants	65.5 units on a scale STANDARD_DEVIATION 11.5 • n=9 Participants	70 units on a scale STANDARD_DEVIATION 11.8 • n=17 Participants
B-1 (thiamine)	150.8 nmol/L STANDARD_DEVIATION 28.7 • n=8 Participants	129.5 nmol/L STANDARD_DEVIATION 36.0 • n=9 Participants	140.1 nmol/L STANDARD_DEVIATION 33.3 • n=17 Participants
B-9 (folate)	15.68 ng/mL STANDARD_DEVIATION 2.01 • n=8 Participants • One sample from usual care was lost.	17.51 ng/mL STANDARD_DEVIATION 1.2 • n=8 Participants • One sample from usual care was lost.	16.06 ng/mL STANDARD_DEVIATION 4.53 • n=16 Participants • One sample from usual care was lost.
B-12 (cobalamin)	663.1 pg/mL STANDARD_DEVIATION 183.6 • n=8 Participants	498.0 pg/mL STANDARD_DEVIATION 153.0 • n=9 Participants	580.5 pg/mL STANDARD_DEVIATION 183.5 • n=17 Participants
K (pg/mL)	1643.4 pg/mL STANDARD_DEVIATION 863.3 • n=8 Participants	1758.3 pg/mL STANDARD_DEVIATION 910.6 • n=9 Participants	1700.8 pg/mL STANDARD_DEVIATION 859.2 • n=17 Participants
HCY	9.4 μmol/L STANDARD_DEVIATION 1.8 • n=8 Participants	9.3 μmol/L STANDARD_DEVIATION 3.7 • n=9 Participants	9.3 μmol/L STANDARD_DEVIATION 3.0 • n=17 Participants
Hs-CRP	4.4 mg/L STANDARD_DEVIATION 4.3 • n=8 Participants	1.4 mg/L STANDARD_DEVIATION 1.2 • n=9 Participants	2.9 mg/L STANDARD_DEVIATION 3.4 • n=17 Participants

PRIMARY outcome

Timeframe: End of Study, measured at 3.5 months; Change from Baseline

Outcome measures

Outcome measures
Measure	Modified Paleo Diet Intervention (MPDI) n=8 Participants Consumed a modified Paleo diet, described as nine cups of vegetables and some fruits, meat protein including organ meat, and complete abstinence from products containing gluten (wheat, barley, rye, etc.), dairy, potatoes, and legumes (beans, lentils, peanuts, soy, etc.) Modified Paleo diet: Nine cups of vegetables and some fruits, meat protein including organ meat, and complete abstinence from products containing gluten (wheat, barley, rye, etc.), dairy, potatoes, and legumes (beans, lentils, peanuts, soy, etc.)	Usual Care n=9 Participants Typical physician recommendations for MS.
Change in Fatigue Severity Scale (FSS)-9 Score Baseline	4.20 units on a scale Standard Error 0.60	3.99 units on a scale Standard Error 0.43
Change in Fatigue Severity Scale (FSS)-9 Score End of study	2.82 units on a scale Standard Error 0.51	4.25 units on a scale Standard Error 0.43

PRIMARY outcome

Timeframe: End of Study, measured at 3.5 months; Change from Baseline

Specific Aims: 1) Test the hypothesis that a modified Paleolithic diet reduces effects of fatigue in subjects with Relapsing-Remitting Multiple Sclerosis (RRMS), compared to controls, in: (b) cognitive fatigue as measured by the Paced Auditory Serial Addition Test (PASAT) score. The PASAT is a measure of cognitive function that assesses auditory information processing speed and flexibility, as well as calculation ability. The PASAT is presented using audio to ensure standardization in the rate of stimulus presentation. Single digits are presented every 3 seconds and the patient must add each new digit to the one immediately prior to it. The score for the PASAT (0-60) is the total number correct out of 60 possible answers.

Outcome measures

Outcome measures
Measure	Modified Paleo Diet Intervention (MPDI) n=8 Participants Consumed a modified Paleo diet, described as nine cups of vegetables and some fruits, meat protein including organ meat, and complete abstinence from products containing gluten (wheat, barley, rye, etc.), dairy, potatoes, and legumes (beans, lentils, peanuts, soy, etc.) Modified Paleo diet: Nine cups of vegetables and some fruits, meat protein including organ meat, and complete abstinence from products containing gluten (wheat, barley, rye, etc.), dairy, potatoes, and legumes (beans, lentils, peanuts, soy, etc.)	Usual Care n=9 Participants Typical physician recommendations for MS.
Change in Paced Auditory Serial Addition Test (PASAT) Score Baseline	44.88 units on a scale Standard Error 1.71	53.22 units on a scale Standard Error 1.78
Change in Paced Auditory Serial Addition Test (PASAT) Score End of Study	49.75 units on a scale Standard Error 2.66	54.89 units on a scale Standard Error 1.30

PRIMARY outcome

Timeframe: End of Study, 3.5 months; Change from Baseline

Specific Aims: 1) Test the hypothesis that a modified Paleolithic diet reduces effects of fatigue in subjects with Relapsing-Remitting Multiple Sclerosis (RRMS), compared to controls, in: (c) physical fatigue as measured by the 6-minute (m) walk (6-MW). Timed 6-minute walk (6-MW): a submaximal measure of gait velocity and endurance over a distance (m) walked in 6 minutes.

Outcome measures

Outcome measures
Measure	Modified Paleo Diet Intervention (MPDI) n=8 Participants Consumed a modified Paleo diet, described as nine cups of vegetables and some fruits, meat protein including organ meat, and complete abstinence from products containing gluten (wheat, barley, rye, etc.), dairy, potatoes, and legumes (beans, lentils, peanuts, soy, etc.) Modified Paleo diet: Nine cups of vegetables and some fruits, meat protein including organ meat, and complete abstinence from products containing gluten (wheat, barley, rye, etc.), dairy, potatoes, and legumes (beans, lentils, peanuts, soy, etc.)	Usual Care n=9 Participants Typical physician recommendations for MS.
Change in 6-minute Walk (6-MW) Distance Baseline	570.11 meters Standard Error 21.15	532.95 meters Standard Error 19.85
Change in 6-minute Walk (6-MW) Distance End of Study	631.14 meters Standard Error 12.30	562.47 meters Standard Error 29.53

PRIMARY outcome

Timeframe: End of Study, measured at 3.5 months; Change from Baseline

Specific Aims: 1) Test the hypothesis that a modified Paleolithic diet reduces effects of fatigue in subjects with Relapsing-Remitting Multiple Sclerosis (RRMS), compared to controls, in: (d) physical fatigue as measured by the 25-ft walk (25-FW; (s). Timed 25-Foot Walk (T25-FW): a quantitative test of maximal walking velocity, mobility, dynamic balance and leg function. The subject is directed to one end of a clearly marked 25-foot course and is instructed to walk 25 feet as quickly and as safely, as possible. The time is recorded from the first step across the line and ends when the patient crosses the same foot over the 25-foot mark. The task is immediately administered again by having the patient walk back the same distance. Patients may use assistive devices when doing this task.

Outcome measures

Outcome measures
Measure	Modified Paleo Diet Intervention (MPDI) n=8 Participants Consumed a modified Paleo diet, described as nine cups of vegetables and some fruits, meat protein including organ meat, and complete abstinence from products containing gluten (wheat, barley, rye, etc.), dairy, potatoes, and legumes (beans, lentils, peanuts, soy, etc.) Modified Paleo diet: Nine cups of vegetables and some fruits, meat protein including organ meat, and complete abstinence from products containing gluten (wheat, barley, rye, etc.), dairy, potatoes, and legumes (beans, lentils, peanuts, soy, etc.)	Usual Care n=9 Participants Typical physician recommendations for MS.
Change in (25-FW) 25-ft Walk Time Baseline	4.67 Seconds Standard Error 0.27	4.65 Seconds Standard Error 0.18
Change in (25-FW) 25-ft Walk Time End of study	4.13 Seconds Standard Error 0.20	4.51 Seconds Standard Error 0.20

SECONDARY outcome

Timeframe: End of Study, measured at 3.5 months; Change from Baseline

Test the hypothesis that a modified Paleolithic diet improves general well-being/health and quality of life of RRMS patients, compared to controls, as measured by: Multiple Sclerosis Quality of Life-54 (MSQOL-54) Mental and Physical Health scores. Multiple Sclerosis Quality of Life-54 (MSQOL-54): a multidimensional health-related quality of life survey that combines both generic and MS-specific items into a single instrument. Higher scores (0-100) indicate improved health.

Outcome measures

Outcome measures
Measure	Modified Paleo Diet Intervention (MPDI) n=8 Participants Consumed a modified Paleo diet, described as nine cups of vegetables and some fruits, meat protein including organ meat, and complete abstinence from products containing gluten (wheat, barley, rye, etc.), dairy, potatoes, and legumes (beans, lentils, peanuts, soy, etc.) Modified Paleo diet: Nine cups of vegetables and some fruits, meat protein including organ meat, and complete abstinence from products containing gluten (wheat, barley, rye, etc.), dairy, potatoes, and legumes (beans, lentils, peanuts, soy, etc.)	Usual Care n=9 Participants Typical physician recommendations for MS.
Quality of Life (MSQOL-54) Physical Baseline	67.26 units on a scale Standard Error 5.76	68.08 units on a scale Standard Error 4.17
Quality of Life (MSQOL-54) Mental Baseline	74.47 units on a scale Standard Error 4.07	65.46 units on a scale Standard Error 4.07
Quality of Life (MSQOL-54) Physical End of Study	81.77 units on a scale Standard Error 3.51	65.62 units on a scale Standard Error 2.77
Quality of Life (MSQOL-54) Mental End of Study	86.53 units on a scale Standard Error 3.51	64.51 units on a scale Standard Error 4.65

SECONDARY outcome

Timeframe: End of Study, measured at 3.5 months; Change from Baseline

Test the hypothesis that a modified Paleolithic diet improves general well-being/health and quality of life of RRMS patients, compared to controls, as measured by vitamin B-1 (thiamine) blood serum measures.

Outcome measures

Outcome measures
Measure	Modified Paleo Diet Intervention (MPDI) n=8 Participants Consumed a modified Paleo diet, described as nine cups of vegetables and some fruits, meat protein including organ meat, and complete abstinence from products containing gluten (wheat, barley, rye, etc.), dairy, potatoes, and legumes (beans, lentils, peanuts, soy, etc.) Modified Paleo diet: Nine cups of vegetables and some fruits, meat protein including organ meat, and complete abstinence from products containing gluten (wheat, barley, rye, etc.), dairy, potatoes, and legumes (beans, lentils, peanuts, soy, etc.)	Usual Care n=9 Participants Typical physician recommendations for MS.
Quality of Life (Vitamin B-1 Blood Serum Measures) B-1 (nmol/L) Baseline	150.75 units listed Standard Error 10.85	129.50 units listed Standard Error 12.74
Quality of Life (Vitamin B-1 Blood Serum Measures) B-1 (nmol/L) End of Study	146.13 units listed Standard Error 21.78	127.11 units listed Standard Error 15.43

SECONDARY outcome

Timeframe: End of Study, measured at 3.5 months; Change from Baseline

Population: One baseline sample from usual care was lost.

Test the hypothesis that a modified Paleolithic diet improves general well-being/health and quality of life of RRMS patients, compared to controls, as measured by vitamin B-9 (folate) blood serum measures.

Outcome measures

Outcome measures
Measure	Modified Paleo Diet Intervention (MPDI) n=8 Participants Consumed a modified Paleo diet, described as nine cups of vegetables and some fruits, meat protein including organ meat, and complete abstinence from products containing gluten (wheat, barley, rye, etc.), dairy, potatoes, and legumes (beans, lentils, peanuts, soy, etc.) Modified Paleo diet: Nine cups of vegetables and some fruits, meat protein including organ meat, and complete abstinence from products containing gluten (wheat, barley, rye, etc.), dairy, potatoes, and legumes (beans, lentils, peanuts, soy, etc.)	Usual Care n=9 Participants Typical physician recommendations for MS.
Quality of Life (Vitamin B-9 Blood Serum Measures) B-9 (ng/mL) Baseline	15.68 ng/mL Standard Error 2.01	17.51 ng/mL Standard Error 1.12
Quality of Life (Vitamin B-9 Blood Serum Measures) B-9 (ng/mL) End of Study	15.61 ng/mL Standard Error 1.99	17.43 ng/mL Standard Error 1.2

SECONDARY outcome

Timeframe: End of Study, measured at 3.5 months; Change from Baseline

Test the hypothesis that a modified Paleolithic diet improves general well-being/health and quality of life of RRMS patients, compared to controls, as measured by blood serum measures: vitamin B-12 (cobalamin) and vitamin K.

Outcome measures

Outcome measures
Measure	Modified Paleo Diet Intervention (MPDI) n=8 Participants Consumed a modified Paleo diet, described as nine cups of vegetables and some fruits, meat protein including organ meat, and complete abstinence from products containing gluten (wheat, barley, rye, etc.), dairy, potatoes, and legumes (beans, lentils, peanuts, soy, etc.) Modified Paleo diet: Nine cups of vegetables and some fruits, meat protein including organ meat, and complete abstinence from products containing gluten (wheat, barley, rye, etc.), dairy, potatoes, and legumes (beans, lentils, peanuts, soy, etc.)	Usual Care n=9 Participants Typical physician recommendations for MS.
Quality of Life (Vitamins B-12 and K Blood Serum Measures) B-12 (pg/mL) Baseline	663.14 pg/mL Standard Error 69.40	497.96 pg/mL Standard Error 54.09
Quality of Life (Vitamins B-12 and K Blood Serum Measures) K (pg/mL) Baseline	1643.38 pg/mL Standard Error 326.28	1758.25 pg/mL Standard Error 321.94
Quality of Life (Vitamins B-12 and K Blood Serum Measures) B-12 (pg/mL) End of Study	638.93 pg/mL Standard Error 75.27	500.21 pg/mL Standard Error 47.67
Quality of Life (Vitamins B-12 and K Blood Serum Measures) K (pg/mL) End of Study	5949.63 pg/mL Standard Error 2100.8	1694.78 pg/mL Standard Error 518.94

SECONDARY outcome

Timeframe: End of Study, measured at 3.5 months; Change from Baseline

Test the hypothesis that a modified Paleolithic diet improves general well-being/health and quality of life of RRMS patients, compared to controls, as measured by homocysteine (HCY) blood serum measures.

Outcome measures

Outcome measures
Measure	Modified Paleo Diet Intervention (MPDI) n=8 Participants Consumed a modified Paleo diet, described as nine cups of vegetables and some fruits, meat protein including organ meat, and complete abstinence from products containing gluten (wheat, barley, rye, etc.), dairy, potatoes, and legumes (beans, lentils, peanuts, soy, etc.) Modified Paleo diet: Nine cups of vegetables and some fruits, meat protein including organ meat, and complete abstinence from products containing gluten (wheat, barley, rye, etc.), dairy, potatoes, and legumes (beans, lentils, peanuts, soy, etc.)	Usual Care n=9 Participants Typical physician recommendations for MS.
Quality of Life (Homocysteine Blood Serum Measures) HCY (μmol/L) Baseline	9.37 μmol/L Standard Error 0.70	9.27 μmol/L Standard Error 1.33
Quality of Life (Homocysteine Blood Serum Measures) HCY (μmol/L) End of Study	9.66 μmol/L Standard Error 0.94	10.01 μmol/L Standard Error 1.57

SECONDARY outcome

Timeframe: End of Study, measured at 3.5 months; Change from Baseline

Test the hypothesis that a modified Paleolithic diet improves general well-being/health and quality of life of RRMS patients, compared to controls, as measured by C-reactive protein (hs-CRP) blood serum measures.

Outcome measures

Outcome measures
Measure	Modified Paleo Diet Intervention (MPDI) n=9 Participants Consumed a modified Paleo diet, described as nine cups of vegetables and some fruits, meat protein including organ meat, and complete abstinence from products containing gluten (wheat, barley, rye, etc.), dairy, potatoes, and legumes (beans, lentils, peanuts, soy, etc.) Modified Paleo diet: Nine cups of vegetables and some fruits, meat protein including organ meat, and complete abstinence from products containing gluten (wheat, barley, rye, etc.), dairy, potatoes, and legumes (beans, lentils, peanuts, soy, etc.)	Usual Care n=9 Participants Typical physician recommendations for MS.
Quality of Life (C-reactive Protein Blood Serum Measures) Hs-CRP (mg/L) End of Study	3.26 mg/L Standard Error 1.75	1.93 mg/L Standard Error 0.52
Quality of Life (C-reactive Protein Blood Serum Measures) Hs-CRP (mg/L) Baseline	4.35 mg/L Standard Error 1.64	1.40 mg/L Standard Error 0.44

SECONDARY outcome

Timeframe: End of Study, measured at 3.5 months; Change from Baseline

Test the hypothesis that a modified Paleolithic diet improves general well-being/health and quality of life of RRMS patients, compared to controls, as measured by the 9-Hole Peg Test (9-HPT). 9-Hole Peg Test: a brief, standardized, quantitative test of upper extremity function. The patient is seated at a table with a small, shallow container holding nine pegs and a wood or plastic block containing nine empty holes (Rolyan 9-Hole Peg Test Kit - Model A8515). On a start command a stopwatch is started, the patient picks up the nine pegs one at a time as quickly as possible, puts them in the nine holes, and, once they are in the holes, removes them again as quickly as possible one at a time, replacing them into the shallow container. The total time to complete the task is recorded. Two consecutive trials with the dominant hand are immediately followed by two consecutive trials with the non-dominant hand. The score for the 9-HPT is an average of the two trials for each hand.

Outcome measures

Outcome measures
Measure	Modified Paleo Diet Intervention (MPDI) n=8 Participants Consumed a modified Paleo diet, described as nine cups of vegetables and some fruits, meat protein including organ meat, and complete abstinence from products containing gluten (wheat, barley, rye, etc.), dairy, potatoes, and legumes (beans, lentils, peanuts, soy, etc.) Modified Paleo diet: Nine cups of vegetables and some fruits, meat protein including organ meat, and complete abstinence from products containing gluten (wheat, barley, rye, etc.), dairy, potatoes, and legumes (beans, lentils, peanuts, soy, etc.)	Usual Care n=9 Participants Typical physician recommendations for MS.
Quality of Life (9-HPT) Dominant End of Study	17.81 seconds Standard Error 0.88	19.02 seconds Standard Error 0.58
Quality of Life (9-HPT) Dominant Baseline	20.98 seconds Standard Error 1.49	19.61 seconds Standard Error 0.72
Quality of Life (9-HPT) Non-dominant Baseline	24.36 seconds Standard Error 1.70	20.41 seconds Standard Error 1.26
Quality of Life (9-HPT) Non-dominant End of Study	19.93 seconds Standard Error 1.23	18.89 seconds Standard Error 0.86

SECONDARY outcome

Timeframe: End of Study, measured at 3.5 months; Change from Baseline

Test the hypothesis that a modified Paleolithic diet improves general well-being/health and quality of life of RRMS patients, compared to controls, as measured by the Veterans Specific Activity Questionnaire (VSAQ). Veterans Specific Activity Questionnaire (VSAQ): a self-reported survey instrument that serves as a strong predictor of both measured and predicted exercise capacity. Subjects identify a series of activities that they can complete on a typical day (scaled 1-11 for estimated metabolic equivalents (METs)), higher METs indicate increased exercise capacity.

Outcome measures

Outcome measures
Measure	Modified Paleo Diet Intervention (MPDI) n=8 Participants Consumed a modified Paleo diet, described as nine cups of vegetables and some fruits, meat protein including organ meat, and complete abstinence from products containing gluten (wheat, barley, rye, etc.), dairy, potatoes, and legumes (beans, lentils, peanuts, soy, etc.) Modified Paleo diet: Nine cups of vegetables and some fruits, meat protein including organ meat, and complete abstinence from products containing gluten (wheat, barley, rye, etc.), dairy, potatoes, and legumes (beans, lentils, peanuts, soy, etc.)	Usual Care n=9 Participants Typical physician recommendations for MS.
Quality of Life (VSAQ) Baseline	6.13 units on a scale Standard Error 0.91	5.78 units on a scale Standard Error 0.88
Quality of Life (VSAQ) End of Study	7.75 units on a scale Standard Error 0.98	5.78 units on a scale Standard Error 0.84

Adverse Events

Modified Paleo Diet Intervention (MPDI)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Usual Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Amanda Irish

University of Iowa

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place