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

NCT02687919 | Completed Results

• 1 other identifier: 201208703
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

This is a research study. The investigators are inviting participants to participate in this research study between the ages of 18-45, who have stable Relapsing-Remitting Multiple Sclerosis (RRMS), are able to walk 25 ft with/without an assistive device, and have none of the following: liver disease, kidney disease, diabetes, active heart disease, heart block or arrhythmias, bleeding disorders, concurrent diuretic use, anti-coagulation or anti-platelet use, psychosis or other psychiatric disorder likely to impact ability to comply with study procedures, any change in prescription medication for a mental health problem such as depression or anxiety in the last three months. The purpose of this research study is to determine whether or not a modified Paleolithic diet results in any change in health in persons with RRMS compared to usual care. The investigators define usual care as the typical or usual physician recommendations for the treatment of RRMS. The Paleolithic diet (or Paleo diet), also referred to as the caveman diet, Stone Age diet, and hunter-gatherer diet, is a modern nutritional plan based on the presumed ancient diet of wild plants and animals of ancestral humans during the Paleolithic era (a period of about 2.5 million years duration that ended around 10,000 years ago with the development of agriculture). The diet consists mainly of fish, grass-fed pasture raised meats, vegetables, fruit, fungi, roots, and nuts, and excludes grains, legumes, dairy products, salt, refined sugar, and processed oils. To the investigators' knowledge, most neurologists prescribe medications that may reduce or prevent future disability, but few prescribe dietary modifications unless needed for other concomitant disease.

Conditions

Multiple Sclerosis, Relapsing-remitting

Keywords

diet (gluten-free); diet therapy; quality of life

Outcome Measures

Primary Outcomes (4)

• Change in Fatigue Severity Scale (FSS)-9 Score

  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.

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

• Change in Paced Auditory Serial Addition Test (PASAT) Score

  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.

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

• Change in 6-minute Walk (6-MW) Distance

  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.

  End of Study, 3.5 months; Change from Baseline

• Change in (25-FW) 25-ft Walk Time

  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.

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

Secondary Outcomes (8)

• Quality of Life (MSQOL-54)

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

• Quality of Life (Vitamin B-1 Blood Serum Measures)

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

• Quality of Life (Vitamin B-9 Blood Serum Measures)

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

• Quality of Life (Vitamins B-12 and K Blood Serum Measures)

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

• Quality of Life (Homocysteine Blood Serum Measures)

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

Study Arms (2)

Modified Paleo Diet Intervention (MPDI)

EXPERIMENTAL

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.)

Other: Modified Paleo diet

Usual Care

NO INTERVENTION

Typical physician recommendations for MS.

Interventions

Modified Paleo diet OTHER

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.)

Also known as: Modified Paleolithic Diet

Modified Paleo Diet Intervention (MPDI)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Verified diagnosis of relapsing-remitting multiple sclerosis (RRMS) with no change in medications in the prior three months.
• Able to ambulate a minimum of 25 feet with/without use of an assistive device.

You may not qualify if:

• Under the age of 18 or over the age of 45 at the beginning of the study.
• Unstable MS, requiring a change in medication in the prior 3 months.
• Unwillingness to contact, or allow research to contact, neurologist for verification of RRMS diagnosis.
• Psychosis or other psychiatric disorder likely to impact ability to comply with study procedures.
• Change in prescriptions medication in the prior three months for a mental health problem such as depression or anxiety.
• Active malignancy undergoing treatment (not including non melanoma skin cancers).
• Subjects with liver disease, kidney disease, diabetes, active heart disease, heart block or arrhythmias, bleeding disorders, concurrent diuretic use, anti-coagulation or anti-platelet use.
• Abnormal bleeding disorder.
• On any "diet" recommended to treat MS (ex: Best Bet, Swank, McDougall, MS Recovery diet, Wahls', other Paleolithic, gluten-free, vegetarian, and/or vegan
• Inability to maintain food log for for seven consecutive days during the run-in phase of the study.
• Not comfortable using a computer.
• Other failure to demonstrate compliance.

Sponsors & Collaborators

• Amanda Irish: lead

Study Sites (1)

University of Iowa

Iowa City, Iowa, 52241, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting

Condition Hierarchy (Ancestors)

Multiple Sclerosis; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Amanda Irish
• Organization: University of Iowa

amanda.k.irish@gmail.com

Study Officials

• Amanda K Irish

  University of Iowa

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: January 22, 2016
• First Posted: February 22, 2016
• Study Start: October 1, 2012
• Primary Completion: September 1, 2014
• Study Completion: October 1, 2014
• Last Updated: August 12, 2019
• Results First Posted: August 12, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will share

Locations

US (1)