Dietary Approaches to Treat Multiple Sclerosis-Related Fatigue Study

Multiple Sclerosis Clinical Trial

— Waves  

Official title:

Dietary Approaches to Treat Multiple Sclerosis-Related Fatigue Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02914964
• Other study ID #: 201604705
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 2016
• Est. completion date: January 26, 2025

Study information

• Verified date: July 2023
• Source: University of Iowa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: January 26, 2025
• Est. primary completion date: January 26, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Fatigue
• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting
• Sclerosis

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of Iowa Hospitals and Clinics	Iowa City	Iowa

Sponsors (2)

Lead Sponsor	Collaborator
Terry L. Wahls	National Multiple Sclerosis Society

Country where clinical trial is conducted

United States, 

References & Publications (13)

Bisht B, Darling WG, Grossmann RE, Shivapour ET, Lutgendorf SK, Snetselaar LG, Hall MJ, Zimmerman MB, Wahls TL. A multimodal intervention for patients with secondary progressive multiple sclerosis: feasibility and effect on fatigue. J Altern Complement Med. 2014 May;20(5):347-55. doi: 10.1089/acm.2013.0188. Epub 2014 Jan 29. — View Citation

Bisht B, Darling WG, 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. Degener Neurol Neuromuscul Dis. 2015;5:19-35. doi: 10.2147/DNND.S76523. Epub 2015 Feb 27. Erratum In: Degener Neurol Neuromuscul Dis. 2015 Sep 10;5:91. — View Citation

SWANK RL, BOURDILLON RB. Multiple sclerosis: assessment of treatment with a modified low-fat diet. J Nerv Ment Dis. 1960 Dec;131:468-88. No abstract available. — View Citation

Swank RL, Dugan BB. Effect of low saturated fat diet in early and late cases of multiple sclerosis. Lancet. 1990 Jul 7;336(8706):37-9. doi: 10.1016/0140-6736(90)91533-g. — View Citation

Swank RL, Goodwin J. Review of MS patient survival on a Swank low saturated fat diet. Nutrition. 2003 Feb;19(2):161-2. doi: 10.1016/s0899-9007(02)00851-1. No abstract available. — View Citation

Swank RL, Goodwin JW. How saturated fats may be a causative factor in multiple sclerosis and other diseases. Nutrition. 2003 May;19(5):478. doi: 10.1016/s0899-9007(02)01099-7. No abstract available. — View Citation

Swank RL. Multiple sclerosis: fat-oil relationship. Nutrition. 1991 Sep-Oct;7(5):368-76. — View Citation

Swank RL. Multiple sclerosis: twenty years on low fat diet. Arch Neurol. 1970 Nov;23(5):460-74. doi: 10.1001/archneur.1970.00480290080009. No abstract available. — View Citation

SWANK RL. Multiple sclerosis; a correlation of its incidence with dietary fat. Am J Med Sci. 1950 Oct;220(4):421-30. No abstract available. — View Citation

SWANK RL. Treatment of multiple sclerosis with a low-fat diet. J Am Diet Assoc. 1960 Apr;36:322-5. No abstract available. — View Citation

SWANK RL. Treatment of multiple sclerosis with low-fat diet. AMA Arch Neurol Psychiatry. 1953 Jan;69(1):91-103. doi: 10.1001/archneurpsyc.1953.02320250097011. No abstract available. — View Citation

SWANK RL. Treatment of multiple sclerosis with low-fat diet: result of seven years' experience. Ann Intern Med. 1956 Nov;45(5):812-24. doi: 10.7326/0003-4819-45-5-812. No abstract available. — View Citation

SWANK RL. Treatment of multiple sclerosis with low-fat diet; results of five and one-half years' experience. AMA Arch Neurol Psychiatry. 1955 Jun;73(6):631-44. doi: 10.1001/archneurpsyc.1955.02330120035004. No abstract available. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in participant perceived fatigue severity	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)	12-24 weeks
Primary	Change in participant perceived fatigue severity	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)	12-36 weeks
Primary	Change in the impact of fatigue on daily life	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.	12-24 weeks
Primary	Change in the impact of fatigue on daily life	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.	12-36 weeks
Secondary	Change in participant walk speed	6 Minute Walk Test	12-24 weeks
Secondary	Change in participant walk speed	6 Minute Walk Test	12-36 weeks
Secondary	Change in gait (walk)	25 foot Walk Test	12-24 weeks
Secondary	Change in gait (walk)	25 foot Walk Test	12-36 weeks
Secondary	Change in fine motor function	Pegboard test	12-24 weeks
Secondary	Change in fine motor function	Pegboard test	12-36 weeks
Secondary	Change in nutrient intake based on the recommended daily allowance (RDA)	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.	12-24 weeks
Secondary	Change in nutrient intake based on the recommended daily allowance (RDA)	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.	12-36 weeks
Secondary	Change in cognitive function	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.	12-24 weeks
Secondary	Change in cognitive function	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.	12-36 weeks
Secondary	Change in steps per day	Measured by accelerometer	12-24 weeks
Secondary	Change in steps per day	Measured by accelerometer	12-36 weeks
Secondary	Change in participant Quality of Life (QoL) - General Health	Multiple Sclerosis 54 Quality of Life Questionnaire. A series of questions about quality of life and social functioning. Score 0 to 100.	12-24 weeks
Secondary	Change in participant Quality of Life (QoL) - General Health	Multiple Sclerosis Quality of Life Questionnaire. A series of questions about quality of life and social functioning. Score 0 to 100.	12-36 weeks
Secondary	Change in participant Quality of Life (QoL) - Mental Health	Multiple Sclerosis Quality of Life Questionnaire A series of questions about quality of life and social functioning. Score 0 to 100.	12-24 weeks
Secondary	Change in participant Quality of Life (QoL) - Mental Health	Multiple Sclerosis Quality of Life Questionnaire A series of questions about quality of life and social functioning. Score 0 to 100.	12-36 weeks
Secondary	Change in total sleep time	Total sleep time is measured in hours and minutes and tracked by accelerometer worn by participants throughout the study	12-24 weeks
Secondary	Change in total sleep time	Total sleep time is measured in hours and minutes and tracked by accelerometer worn by participants throughout the study	12-36 weeks
Secondary	Change in perceived anxiety	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.	12-24 weeks
Secondary	Change in perceived anxiety	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.	12-36 weeks
Secondary	Change in perceived depression	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.	12-24 weeks
Secondary	Change in perceived depression	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.	12-36 weeks

External Links

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