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Evaluation of a Modified Paleolithic Dietary Intervention in the Treatment of Relapsing-Remitting Multiple Sclerosis

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ClinicalTrials.gov Identifier: NCT02687919
Recruitment Status : Completed
First Posted : February 22, 2016
Results First Posted : August 12, 2019
Last Update Posted : August 12, 2019
Sponsor:
Information provided by (Responsible Party):
Amanda Irish, University of Iowa

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Multiple Sclerosis, Relapsing-remitting
Intervention Other: Modified Paleo diet
Enrollment 31
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Modified Paleo Diet Intervention (MPDI) Usual Care
Hide Arm/Group Description

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.)

Typical physician recommendations for MS.
Period Title: Overall Study
Started 16 15
Completed 8 9
Not Completed 8 6
Reason Not Completed
Withdrawal by Subject             6             6
Protocol Violation             2             0
Arm/Group Title Modified Paleo Diet Intervention (MPDI) Usual Care Total
Hide Arm/Group Description

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.)

Typical physician recommendations for MS. Total of all reporting groups
Overall Number of Baseline Participants 8 9 17
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 8 participants 9 participants 17 participants
35.4  (5.7) 37.1  (3.7) 36.2  (4.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 9 participants 17 participants
Female
7
  87.5%
8
  88.9%
15
  88.2%
Male
1
  12.5%
1
  11.1%
2
  11.8%
Fatigue Severity Scale (FSS)-9   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 8 participants 9 participants 17 participants
4.2  (1.6) 4.0  (1.2) 4.1  (1.4)
[1]
Measure Description: Higher score (1-7) indicates more fatigue. The total score is the average of 9 questions.
Veterans Specific Activity Questionnaire (VSAQ)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 8 participants 9 participants 17 participants
6.1  (2.4) 5.8  (2.5) 6.0  (2.4)
[1]
Measure Description: Estimates exercise tolerance in metabolic equivalents (METs). A higher score (1-13) indicates better exercise tolerance.
Timed 25-Foot Walk (25-FW)   [1] 
Mean (Standard Deviation)
Unit of measure:  Seconds
Number Analyzed 8 participants 9 participants 17 participants
4.7  (0.7) 4.7  (0.5) 4.7  (0.6)
[1]
Measure Description: Quantitative mobility and leg function performance test based on a timed 25-foot walk. Less time to complete indicates less physical fatigue.
9-Hole Peg Test (9-HPT) (dominant)   [1] 
Mean (Standard Deviation)
Unit of measure:  Seconds
Number Analyzed 8 participants 9 participants 17 participants
21.0  (3.9) 19.6  (2.0) 20.3  (3.1)
[1]
Measure Description: On a start command, a stopwatch is started, the patient picks up 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 two trials for each hand are averaged.
9-Hole Peg Test (9-HPT) (nondominant)   [1] 
Mean (Standard Deviation)
Unit of measure:  Seconds
Number Analyzed 8 participants 9 participants 17 participants
24.4  (4.5) 20.4  (3.6) 22.4  (4.4)
[1]
Measure Description: On a start command, a stopwatch is started, the patient picks up 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 two trials for each hand are averaged.
Paced Auditory Serial Addition Test (PASAT)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 8 participants 9 participants 17 participants
44.9  (4.5) 53.2  (5.0) 49  (6.3)
[1]
Measure Description: Total number correct out of 60 possible answers. A higher score indicates reduced cognitive fatigue.
6 Minute Walk (6-MW)   [1] 
Mean (Standard Deviation)
Unit of measure:  Meters
Number Analyzed 8 participants 9 participants 17 participants
570.1  (56.0) 532.9  (56.1) 551.5  (57.5)
[1]
Measure Description: Assesses submaximal aerobic capacity/endurance through measuring distance walked in 6 minutes. Greater distance indicates less physical fatigue.
Multiple Sclerosis Quality of Life-54 (MSQOL-54) (physical)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 8 participants 9 participants 17 participants
67.3  (15.2) 68.1  (11.8) 67.7  (13.1)
[1]
Measure Description: This 54-item instrument generates two composite summary scores, physical health and mental health. Higher scores (0-100) indicate improved health.
Multiple Sclerosis Quality of Life-54 (MSQOL-54) (mental)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 8 participants 9 participants 17 participants
74.5  (10.8) 65.5  (11.5) 70  (11.8)
[1]
Measure Description: This 54-item instrument generates two composite summary scores, physical health and mental health. Higher scores (0-100) indicate improved health.
B-1 (thiamine)  
Mean (Standard Deviation)
Unit of measure:  nmol/L
Number Analyzed 8 participants 9 participants 17 participants
150.8  (28.7) 129.5  (36.0) 140.1  (33.3)
B-9 (folate)   [1] 
Mean (Standard Deviation)
Unit of measure:  ng/mL
Number Analyzed 8 participants 8 participants 16 participants
15.68  (2.01) 17.51  (1.2) 16.06  (4.53)
[1]
Measure Analysis Population Description: One sample from usual care was lost.
B-12 (cobalamin)  
Mean (Standard Deviation)
Unit of measure:  pg/mL
Number Analyzed 8 participants 9 participants 17 participants
663.1  (183.6) 498.0  (153.0) 580.5  (183.5)
K (pg/mL)  
Mean (Standard Deviation)
Unit of measure:  pg/mL
Number Analyzed 8 participants 9 participants 17 participants
1643.4  (863.3) 1758.3  (910.6) 1700.8  (859.2)
HCY  
Mean (Standard Deviation)
Unit of measure:  μmol/L
Number Analyzed 8 participants 9 participants 17 participants
9.4  (1.8) 9.3  (3.7) 9.3  (3.0)
Hs-CRP  
Mean (Standard Deviation)
Unit of measure:  mg/L
Number Analyzed 8 participants 9 participants 17 participants
4.4  (4.3) 1.4  (1.2) 2.9  (3.4)
1.Primary Outcome
Title Change in Fatigue Severity Scale (FSS)-9 Score
Hide Description

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.

Time Frame End of Study, measured at 3.5 months; Change from Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Modified Paleo Diet Intervention (MPDI) Usual Care
Hide Arm/Group Description:

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.)

Typical physician recommendations for MS.
Overall Number of Participants Analyzed 8 9
Mean (Standard Error)
Unit of Measure: units on a scale
Baseline 4.20  (0.60) 3.99  (0.43)
End of study 2.82  (0.51) 4.25  (0.43)
2.Primary Outcome
Title Change in Paced Auditory Serial Addition Test (PASAT) Score
Hide Description

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.

Time Frame End of Study, measured at 3.5 months; Change from Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Modified Paleo Diet Intervention (MPDI) Usual Care
Hide Arm/Group Description:

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.)

Typical physician recommendations for MS.
Overall Number of Participants Analyzed 8 9
Mean (Standard Error)
Unit of Measure: units on a scale
Baseline 44.88  (1.71) 53.22  (1.78)
End of Study 49.75  (2.66) 54.89  (1.30)
3.Primary Outcome
Title Change in 6-minute Walk (6-MW) Distance
Hide Description

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.

Time Frame End of Study, 3.5 months; Change from Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Modified Paleo Diet Intervention (MPDI) Usual Care
Hide Arm/Group Description:

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.)

Typical physician recommendations for MS.
Overall Number of Participants Analyzed 8 9
Mean (Standard Error)
Unit of Measure: meters
Baseline 570.11  (21.15) 532.95  (19.85)
End of Study 631.14  (12.30) 562.47  (29.53)
4.Primary Outcome
Title Change in (25-FW) 25-ft Walk Time
Hide Description

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.

Time Frame End of Study, measured at 3.5 months; Change from Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Modified Paleo Diet Intervention (MPDI) Usual Care
Hide Arm/Group Description:

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.)

Typical physician recommendations for MS.
Overall Number of Participants Analyzed 8 9
Mean (Standard Error)
Unit of Measure: Seconds
Baseline 4.67  (0.27) 4.65  (0.18)
End of study 4.13  (0.20) 4.51  (0.20)
5.Secondary Outcome
Title Quality of Life (MSQOL-54)
Hide Description

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.

Time Frame End of Study, measured at 3.5 months; Change from Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Modified Paleo Diet Intervention (MPDI) Usual Care
Hide Arm/Group Description:

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.)

Typical physician recommendations for MS.
Overall Number of Participants Analyzed 8 9
Mean (Standard Error)
Unit of Measure: units on a scale
Physical Baseline 67.26  (5.76) 68.08  (4.17)
Mental Baseline 74.47  (4.07) 65.46  (4.07)
Physical End of Study 81.77  (3.51) 65.62  (2.77)
Mental End of Study 86.53  (3.51) 64.51  (4.65)
6.Secondary Outcome
Title Quality of Life (Vitamin B-1 Blood Serum Measures)
Hide Description 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.
Time Frame End of Study, measured at 3.5 months; Change from Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Modified Paleo Diet Intervention (MPDI) Usual Care
Hide Arm/Group Description:

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.)

Typical physician recommendations for MS.
Overall Number of Participants Analyzed 8 9
Mean (Standard Error)
Unit of Measure: units listed
B-1 (nmol/L) Baseline 150.75  (10.85) 129.50  (12.74)
B-1 (nmol/L) End of Study 146.13  (21.78) 127.11  (15.43)
7.Secondary Outcome
Title Quality of Life (Vitamin B-9 Blood Serum Measures)
Hide Description 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.
Time Frame End of Study, measured at 3.5 months; Change from Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
One baseline sample from usual care was lost.
Arm/Group Title Modified Paleo Diet Intervention (MPDI) Usual Care
Hide Arm/Group Description:

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.)

Typical physician recommendations for MS.
Overall Number of Participants Analyzed 8 9
Mean (Standard Error)
Unit of Measure: ng/mL
B-9 (ng/mL) Baseline Number Analyzed 8 participants 8 participants
15.68  (2.01) 17.51  (1.12)
B-9 (ng/mL) End of Study Number Analyzed 8 participants 9 participants
15.61  (1.99) 17.43  (1.2)
8.Secondary Outcome
Title Quality of Life (Vitamins B-12 and K Blood Serum Measures)
Hide Description 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.
Time Frame End of Study, measured at 3.5 months; Change from Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Modified Paleo Diet Intervention (MPDI) Usual Care
Hide Arm/Group Description:

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.)

Typical physician recommendations for MS.
Overall Number of Participants Analyzed 8 9
Mean (Standard Error)
Unit of Measure: pg/mL
B-12 (pg/mL) Baseline 663.14  (69.40) 497.96  (54.09)
K (pg/mL) Baseline 1643.38  (326.28) 1758.25  (321.94)
B-12 (pg/mL) End of Study 638.93  (75.27) 500.21  (47.67)
K (pg/mL) End of Study 5949.63  (2100.8) 1694.78  (518.94)
9.Secondary Outcome
Title Quality of Life (Homocysteine Blood Serum Measures)
Hide Description 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.
Time Frame End of Study, measured at 3.5 months; Change from Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Modified Paleo Diet Intervention (MPDI) Usual Care
Hide Arm/Group Description:

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.)

Typical physician recommendations for MS.
Overall Number of Participants Analyzed 8 9
Mean (Standard Error)
Unit of Measure: μmol/L
HCY (μmol/L) Baseline 9.37  (0.70) 9.27  (1.33)
HCY (μmol/L) End of Study 9.66  (0.94) 10.01  (1.57)
10.Secondary Outcome
Title Quality of Life (C-reactive Protein Blood Serum Measures)
Hide Description 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.
Time Frame End of Study, measured at 3.5 months; Change from Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Modified Paleo Diet Intervention (MPDI) Usual Care
Hide Arm/Group Description:

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.)

Typical physician recommendations for MS.
Overall Number of Participants Analyzed 9 9
Mean (Standard Error)
Unit of Measure: mg/L
Hs-CRP (mg/L) Baseline 4.35  (1.64) 1.40  (0.44)
Hs-CRP (mg/L) End of Study 3.26  (1.75) 1.93  (0.52)
11.Secondary Outcome
Title Quality of Life (9-HPT)
Hide Description

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.

Time Frame End of Study, measured at 3.5 months; Change from Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Modified Paleo Diet Intervention (MPDI) Usual Care
Hide Arm/Group Description:

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.)

Typical physician recommendations for MS.
Overall Number of Participants Analyzed 8 9
Mean (Standard Error)
Unit of Measure: seconds
Dominant Baseline 20.98  (1.49) 19.61  (0.72)
Non-dominant Baseline 24.36  (1.70) 20.41  (1.26)
Dominant End of Study 17.81  (0.88) 19.02  (0.58)
Non-dominant End of Study 19.93  (1.23) 18.89  (0.86)
12.Secondary Outcome
Title Quality of Life (VSAQ)
Hide Description

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.

Time Frame End of Study, measured at 3.5 months; Change from Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Modified Paleo Diet Intervention (MPDI) Usual Care
Hide Arm/Group Description:

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.)

Typical physician recommendations for MS.
Overall Number of Participants Analyzed 8 9
Mean (Standard Error)
Unit of Measure: units on a scale
Baseline 6.13  (0.91) 5.78  (0.88)
End of Study 7.75  (0.98) 5.78  (0.84)
Time Frame Length of participant involvement (3.5 mos or 6.5 mos for cross-over subjects).
Adverse Event Reporting Description No adverse events were reported by subjects.
 
Arm/Group Title Modified Paleo Diet Intervention (MPDI) Usual Care
Hide Arm/Group Description

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.)

Typical physician recommendations for MS.
All-Cause Mortality
Modified Paleo Diet Intervention (MPDI) Usual Care
Affected / at Risk (%) Affected / at Risk (%)
Total   0/9 (0.00%)   0/8 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Modified Paleo Diet Intervention (MPDI) Usual Care
Affected / at Risk (%) Affected / at Risk (%)
Total   0/9 (0.00%)   0/8 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Modified Paleo Diet Intervention (MPDI) Usual Care
Affected / at Risk (%) Affected / at Risk (%)
Total   0/9 (0.00%)   0/8 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Amanda Irish
Organization: University of Iowa
EMail: amanda.k.irish@gmail.com
Layout table for additonal information
Responsible Party: Amanda Irish, University of Iowa
ClinicalTrials.gov Identifier: NCT02687919     History of Changes
Other Study ID Numbers: 201208703
First Submitted: January 22, 2016
First Posted: February 22, 2016
Results First Submitted: May 10, 2017
Results First Posted: August 12, 2019
Last Update Posted: August 12, 2019