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Dietary Approaches to Treat Multiple Sclerosis-Related Fatigue Study

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ClinicalTrials.gov Identifier: NCT02914964
Recruitment Status : Recruiting
First Posted : September 26, 2016
Last Update Posted : June 26, 2018
Sponsor:
Collaborator:
National Multiple Sclerosis Society
Information provided by (Responsible Party):
Terry L. Wahls, University of Iowa

Brief Summary:
The purpose of this study is to compare the effect of the Swank Diet (low saturated fat) and the Wahls Elimination Diet (modified paleo) on fatigue levels in individuals with relapsing-remitting multiple sclerosis who have documented fatigue. Participants will follow their usual diet for 12 weeks and then be randomly assigned to follow one of the two diets for 24 weeks.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Multiple Sclerosis, Relapsing-Remitting Behavioral: Swank Diet Behavioral: Wahls Elimination Diet Not Applicable

Detailed Description:

The purpose of this study is to compare the effect of the Swank Diet (low saturated fat) and the Wahls Elimination Diet (modified paleo) on fatigue levels in individuals with relapsing-remitting multiple sclerosis who have documented fatigue. Participants will follow their usual diet for 12 weeks and then be randomly assigned to follow one of the two diets for 24 weeks. Individuals will continue with their current treatments in addition to following the study diet.

The study requires four visits to the University of Iowa Hospitals and Clinics in Iowa City, Iowa. Visits will be 12 weeks apart. Study activities include fasting blood draws, weighed food records, motor and cognitive testing, physical activity assessment, questionnaires, and daily diet checklists while following the study diet. Some reimbursement available.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Dietary Approaches to Treat Multiple Sclerosis-Related Fatigue Study
Actual Study Start Date : August 2016
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Swank Diet
Individuals randomized to this arm will follow a low saturated fat diet starting at week 12.
Behavioral: Swank Diet
A Registered Dietitian Nutritionist (RDN) skilled in motivational interviewing will provide nutrition counseling to study participants to assist them in following the Swank Diet at home. An in-person counseling session will occur at study visits 2 and 3. Five telephone counseling calls will occur between visits 2 and 3. The study participant may contact the RDN with questions at any time during the intervention.

Experimental: Wahls Elimination Diet
Individuals randomized to this arm will follow a modified paleolithic diet that eliminates all grains, dairy, eggs, legumes, and nightshade vegetables/spices starting at week 12.
Behavioral: Wahls Elimination Diet
A Registered Dietitian Nutritionist (RDN) skilled in motivational interviewing will provide nutrition counseling using to study participants to assist them in following the Wahls Elimination Diet at home. An in-person counseling session will occur at study visits 2 and 3. Five telephone counseling calls will occur between visits 2 and 3. The study participant may contact the RDN with questions at any time during the intervention.




Primary Outcome Measures :
  1. Change in participant perceived fatigue severity [ Time Frame: 12-24 weeks ]
    Participant questionnaire asking about fatigue: Fatigue Severity Scale score - a 9-questions scale ranging from 1 (complete disagreement with the question) to 7 (complete agreement with the questions)

  2. Change in participant perceived fatigue severity [ Time Frame: 12-36 weeks ]
    Participant questionnaire asking about fatigue: Fatigue Severity Scale score - a 9-questions scale ranging from 1 (complete disagreement with the question) to 7 (complete agreement with the questions)

  3. Change in the impact of fatigue on daily life [ Time Frame: 12-24 weeks ]
    Modified Fatigue Impact Scale score: Participant questionnaire asking about impact of fatigue impact daily life: Modified Fatigue Impact Scale score. This instrument provides an assessment of the effects of fatigue in terms of physical, cognitive, and psychosocial functioning. The MFIS consists of 21 items. Scoring is based upon a sum of the responses. Total score ranges from 0 to 84.

  4. Change in the impact of fatigue on daily life [ Time Frame: 12-36 weeks ]
    Modified Fatigue Impact Scale score: Participant questionnaire asking about impact of fatigue impact daily life: Modified Fatigue Impact Scale score. This instrument provides an assessment of the effects of fatigue in terms of physical, cognitive, and psychosocial functioning. The MFIS consists of 21 items. Scoring is based upon a sum of the responses. Total score ranges from 0 to 84.


Secondary Outcome Measures :
  1. Change in participant walk speed [ Time Frame: 12-24 weeks ]
    6 Minute Walk Test

  2. Change in participant walk speed [ Time Frame: 12-36 weeks ]
    6 Minute Walk Test

  3. Change in gait (walk) [ Time Frame: 12-24 weeks ]
    25 foot Walk Test

  4. Change in gait (walk) [ Time Frame: 12-36 weeks ]
    25 foot Walk Test

  5. Change in fine motor function [ Time Frame: 12-24 weeks ]
    Pegboard test

  6. Change in fine motor function [ Time Frame: 12-36 weeks ]
    Pegboard test

  7. Change in nutrient intake based on the recommended daily allowance (RDA) [ Time Frame: 12-24 weeks ]
    Nutrient intake calculated from 3-day weighed food records and Food Frequency Questionnaire and Participant blood measurements of insulin, glucose, hemoglobin A1C, Vitamin K, homocysteine, lipids, fatty acid profile and vitamin D.

  8. Change in nutrient intake based on the recommended daily allowance (RDA) [ Time Frame: 12-36 weeks ]
    Nutrient intake calculated from 3-day weighed food records and Food Frequency Questionnaire and Participant blood measurements of insulin, glucose, hemoglobin A1C, Vitamin K, homocysteine, lipids, fatty acid profile and vitamin D.

  9. Change in cognitive function [ Time Frame: 12-24 weeks ]
    Symbol Digit Modalities Test - oral. An oral test of sequencing symbols. •Participant substitutes a number for meaningless geometric shapes based on a key that assigns a specific number to each shape. Scoring is based on the number of correct substitutions.

  10. Change in cognitive function [ Time Frame: 12-36 weeks ]
    Symbol Digit Modalities Test - oral. An oral test of sequencing symbols. •Participant substitutes a number for meaningless geometric shapes based on a key that assigns a specific number to each shape. Scoring is based on the number of correct substitutions.

  11. Change in steps per day [ Time Frame: 12-24 weeks ]
    Measured by accelerometer

  12. Change in steps per day [ Time Frame: 12-36 weeks ]
    Measured by accelerometer

  13. Change in participant Quality of Life (QoL) - General Health [ Time Frame: 12-24 weeks ]
    Multiple Sclerosis 54 Quality of Life Questionnaire. A series of questions about quality of life and social functioning. Score 0 to 100.

  14. Change in participant Quality of Life (QoL) - General Health [ Time Frame: 12-36 weeks ]
    Multiple Sclerosis Quality of Life Questionnaire. A series of questions about quality of life and social functioning. Score 0 to 100.

  15. Change in participant Quality of Life (QoL) - Mental Health [ Time Frame: 12-24 weeks ]
    Multiple Sclerosis Quality of Life Questionnaire A series of questions about quality of life and social functioning. Score 0 to 100.

  16. Change in participant Quality of Life (QoL) - Mental Health [ Time Frame: 12-36 weeks ]
    Multiple Sclerosis Quality of Life Questionnaire A series of questions about quality of life and social functioning. Score 0 to 100.

  17. Change in total sleep time [ Time Frame: 12-24 weeks ]
    Total sleep time is measured in hours and minutes and tracked by accelerometer worn by participants throughout the study

  18. Change in total sleep time [ Time Frame: 12-36 weeks ]
    Total sleep time is measured in hours and minutes and tracked by accelerometer worn by participants throughout the study

  19. Change in perceived anxiety [ Time Frame: 12-24 weeks ]
    Perceived anxiety is measured by the Hospital Anxiety and Depression Scale (HADS), a 14 question scale ranging from 0-3 with zero being being low or no occurrence and 3 being high occurrence.

  20. Change in perceived anxiety [ Time Frame: 12-36 weeks ]
    Perceived anxiety is measured by the Hospital Anxiety and Depression Scale (HADS), a 14 question scale ranging from 0-3 with zero being being low or no occurrence and 3 being high occurrence.

  21. Change in perceived depression [ Time Frame: 12-24 weeks ]
    Perceived depression is measured by the Hospital Anxiety and Depression Scale (HADS), a 14 question scale ranging from 0-3 with zero being being low or no occurrence and 3 being high occurrence.

  22. Change in perceived depression [ Time Frame: 12-36 weeks ]
    Perceived depression is measured by the Hospital Anxiety and Depression Scale (HADS), a 14 question scale ranging from 0-3 with zero being being low or no occurrence and 3 being high occurrence.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Willing to allow your neurologist to sign a letter confirming multiple sclerosis diagnosis and criteria used in diagnosis
  • Relapsing-Remitting Multiple Sclerosis as documented by the McDonald Criteria confirmed by their treating neurologist
  • Fatigue as documented by a Fatigue Severity Scale score of greater than or equal to 4
  • Between the ages of 18 and 70
  • Body Mass Index greater than or equal to 19
  • Ability to shop for and prepare or have someone in the family shop for and prepare home cooked meals according to study diet guidelines
  • Willingness to keep detailed food records
  • Willing to eat a diet that includes more vegetables and excludes many comfort foods such as those made with white flour,
  • Willing to eat a diet that eliminates red meat (beef, pork, lamb, veal) and saturated fats (butter, coconut oil, margarine, hydrogenated oils found in processed foods) to 1 tablespoon per day
  • Must not be pregnant or planning to become pregnant in the next year
  • Willing to eat meat (eg, chicken, turkey, fish)
  • Willingness to follow either the Wahls Elimination diet or the Swank diet
  • Individuals who have had gastric bypass surgery have obtained a signed statement from their physician indicating they are weight stable and a suitable candidate for this study
  • Normal or mild cognitive impairment as measured by the Short Portable Mental Status Questionnaire
  • Willing to have blood drawn
  • Be able to walk 25 feet without support, or with only unilateral support (i.e. cane in one hand)

Exclusion Criteria:

  • Taking insulin or Coumadin
  • Relapse within past 12 weeks
  • Treatment for a cancer (other than skin cancer) currently or in the prior 12 months
  • Diagnosis of heart failure, liver cirrhosis, angina, history of kidney stones, psychiatric disease likely to make adherence to the study interventions more difficult including eating disorders, but excluding depression and anxiety
  • Body Mass Index less than 19
  • Moderate to severe mental impairment as measured by the Short Portable Mental Status questionnaire
  • Inability to shop for and prepare home cooked meals by the subject or a companion
  • Unwillingness to eat meat
  • Participation in another research study that involves multiple sclerosis or other medications, diet, supplement, exercise or other treatments
  • Inability to keep food records with sufficient detail to asses dietary intake or complete study questionnaires
  • Unwilling to have blood drawn
  • Pregnant or planning to become pregnant in the next year

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02914964


Contacts
Contact: Mary Ehlinger, BS 319-384-5002 MSDietStudy@healthcare.uiowa.edu
Contact: Zaidoon AlShare, MD 319-384-5186 MSDietStudy@healthcare.uiowa.edu

Locations
United States, Iowa
University of Iowa Hospitals and Clinics Recruiting
Iowa City, Iowa, United States, 52242
Contact: Mary Ehlinger, BS    319-384-5002    MSDietStudy@healthcare.uiowa.edu   
Contact: Michaella Fowler, BS    319-384-5002    MSDietStudy@healthcare.uiowa.edu   
Principal Investigator: Terry L Wahls, MD, MBA         
Sponsors and Collaborators
Terry L. Wahls
National Multiple Sclerosis Society
Investigators
Principal Investigator: Terry L Wahls, MD, MBA University of Iowa
Principal Investigator: Linda Snetselaar, PhD, RD, University of Iowa

Additional Information:
Publications:
Bisht B; Shivapour ET; Lutgendorf SK; Snetselaar LG; Chenard CA; Wahls TL. Multimodal intervention improves fatigue and quality of life in subjects with progressive multiple sclerosis: a pilot study Degenerative Neurological and Neuromuscular Disease. 2015;5:19-35. doi: http://dx.doi.org/10.2147/DNND.S76523
Bisht B; Shivapour ET; Lutgendorf SK; Snetselaar LG; Chenard CA; Wahls TL. Multimodal intervention improves fatigue and quality of life in subjects with progressive multiple sclerosis: a pilot study [Corrigendum]. Degenerative Neurological and Neuromuscular Disease. 2015;5:91-2. doi: http://dx.doi.org/10.2147/DNND.S94278.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Terry L. Wahls, Clinical Professor, University of Iowa
ClinicalTrials.gov Identifier: NCT02914964     History of Changes
Other Study ID Numbers: 201604705
First Posted: September 26, 2016    Key Record Dates
Last Update Posted: June 26, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Terry L. Wahls, University of Iowa:
Fatigue
Quality of Life
Diet

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Fatigue
Multiple Sclerosis, Relapsing-Remitting
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Signs and Symptoms