A Pragmatic Trial of Dietary Programs in People With Multiple Sclerosis (MS)

A Pragmatic Trial of Dietary Programs in People With Multiple Sclerosis

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02846558

Enrollment

Registered

2016-07-27

Start date

2016-08-31

Completion date

2017-07-31

Last updated

2018-06-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis

Keywords

calorie restriction, weight loss

Brief summary

This is a pragmatic, single-blinded randomized trial of improving adherence to dietary interventions in patients with MS who are receiving monthly natalizumab infusions.

Detailed description

MS affects at least 400,000 people in the US alone, and its incidence has increased in the past 50 years, likely due to changing environmental risk factors. Recent research suggests that diet may be a critical factor in the development of MS. The Western diet, high in sugar, fat, and salt, may influence MS risk and progression by directly affecting the immune system, altering gut bacteria, and changing metabolism. Studying patients with MS who are overweight and obese may be relevant as obesity can cause chronic low-grade inflammation, potentially worsening MS symptoms. Diet modification represents an interesting potential therapy for MS, particularly calorie restriction and fasting, which have been associated with reduced markers of inflammation. In addition to these direct effects, weight optimization may lead to improvements in MS-related symptoms, like fatigue, and overall quality of life. This is a single-blinded randomized trial of adherence to a dietary intervention in patients with MS who are receiving monthly natalizumab infusions. The study will evaluate how use of technology may help patients with MS adhere to a calorie restricted diet. It will also evaluate the effect of weight loss on fatigue and quality of life in patients with MS. A second part of the study will evaluate if shortening the period during the day in which people consume their typical food amounts leads to improvements in patient-reported outcomes.

Interventions

OTHERFrequent Patient Interaction

Weekly informational and supportive text messages will be sent to patients, encouraging adherence to the calorie restriction diet.

BEHAVIORALTiming Restriction

Patients continue to follow their normal diet, but limit food intake to an 8-hour period during the day.

DEVICELoseIt! Smartphone Application

Patients will be trained by study staff to download the LoseIt! application, and use it to log all food intake throughout the study duration. Data collected from the application will be the primary measure of adherence to dietary changes.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

* Body Mass Index (BMI) ≥ 25 kg/m\^2 for calorie restriction study * BMI \< 25 kg/m\^2, or ≥ 25 kg/m\^2 if participant was unwilling to enroll in calorie restriction study * Smartphone with the ability to download and use the LoseIt! application (calorie restriction only) * Smartphone with the ability to take and store photos (calorie timing only)

Exclusion criteria

* History of diabetes requiring medication * Currently pregnant or breastfeeding * History of an eating disorder * Currently taking warfarin * History of major surgery within past 3 months

Design outcomes

Primary

Measure	Time frame	Description
Adherence	Baseline and 6 months	Number of participants adhering to the prescribed dietary intervention at the end of the 6-month study period.

Secondary

Measure	Time frame	Description
Weight Change	Baseline and 6 months	Change in participant weight over the 6-month study period
Weight Change Among Adherent Participants	Baseline and 6 months	The change in weight over 6 months among participants were remained adherence to the calorie restriction diet versus those who admitted to non-compliance by the end of the study period.
Functional Assessment in MS Score	Baseline and 6 months	The Functional Assessment in Multiple Sclerosis (FAMS) is an instrument that measures quality of life among people with MS. The instrument contains 44 questions scored on a 5-point Likert scale in 6 areas: mobility, symptoms, emotional wellbeing, general contentment, thanking/fatigue, and family/social wellbeing. Subscores for each area is calculated as the sum of responses in that section, and the total FAMS score is the sum of all subscores. Minimum total score is 0 and maximum total score is 176, where a higher score indicates better quality of life. Increase in the FAMS score over the study period indicates a better outcome, or improved quality of life, among participants.
Body Mass Index (BMI)	Baseline and 6 months	Change in body mass index from baseline to 6 months.
Sleep Quality	Baseline and 6 months	The Pittsburgh Sleep Quality Index (PSQI) is an instrument used to measure the quality and sleeping pattern of adults. It differentiates poor from good sleep quality, and the total score is calculated from the sum of seven components, each scored from 0 to 3. The minimum total score is 0 and the maximum total score is 21. A total score equal to or greater than 5 units indicates poor quality sleep, while a score of 0-4 indicates good quality sleep; lower scores indicate better sleep quality. Decrease in PSQI score indicates a better outcome, or improved sleep quality, among study participants.
Self-esteem	Baseline and 6 months	The Rosenberg Self-Esteem Scale (RSES) is a 10-item scale that measures global self-worth using a 4-point Likert scale to ask about negative and positive feelings about the self. Individual items are summed to calculate the total score. Minimum score is 0 and maximum score is 30. Scores between 15 and 25 are considered within the normal range, while scores below 15 indicates poor self-esteem. An increase in RSES score over 6 months indicates a better outcome, or improved self-esteem, among participants.
Fatigue	Baseline and 6 months	The Patient-Reported Outcomes Measurement Information System (PROMIS) - Fatigue is a question bank of 95 items validated to evaluated fatigue in a variety of chronic conditions. The PROMIS-FatigueMS is a subset of 8 questions from the question bank, which have been validated to measure fatigue in people with multiple sclerosis. Individual items are scored on a 5-point Likert scale, and the total score is the sum of individual items, with a minimum score of 8 and maximum score of 40. Lower scores indicate less fatigue, while higher scores indicate more fatigue. Reduction in score over 6 months indicates a better outcome, or improved fatigue among participants.

Participant flow

Participants by arm

Arm	Count
Calorie Restriction - Frequent Patient Communication Participants select to restrict calories continuously (25% daily) or intermittently (76% twice per week) for the 6-month study period. Weekly informational and supportive text messages will be sent to patients, encouraging adherence to the calorie restriction diet.	10
Calorie Restriction - Communication Standard of Care Participants select to restrict calories continuously (25% daily) or intermittently (76% twice per week) for the 6-month study period. Participants will not receive additional support or interaction from the study team apart from the scheduled study visits.	9
Timing Restriction Patients who do not qualify for, or do not wish to complete, the calorie restriction diet, may be randomized to time restriction. In this arm, participants restrict their calorie intake to an 8-hour interval each day, providing time for a 16-hour fast between intervals.	12
No Diet Change Patients who do not qualify for, or do not wish to complete, the calorie restriction diet, may be randomized to not make any diet changes. This group is instructed to continue eating their normal diet throughout the 6-month study period.	12
Total	43

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002	FG003
Overall Study	Adverse Event	1	0	0	0
Overall Study	Lost to Follow-up	2	0	0	0
Overall Study	Withdrawal by Subject	5	4	2	2

Baseline characteristics

Characteristic	Calorie Restriction - Communication Standard of Care	Total	No Diet Change	Calorie Restriction - Frequent Patient Communication	Timing Restriction
Age, Continuous	31.18 years STANDARD_DEVIATION 3.79	41.73 years STANDARD_DEVIATION 11.31	43.42 years STANDARD_DEVIATION 11.77	31.10 years STANDARD_DEVIATION 6	39.83 years STANDARD_DEVIATION 10.94
BMI	30.22 kg/m^2 STANDARD_DEVIATION 4.78	28.00 kg/m^2 STANDARD_DEVIATION 6.21	25.86 kg/m^2 STANDARD_DEVIATION 6.22	30.04 kg/m^2 STANDARD_DEVIATION 6.52	24.28 kg/m^2 STANDARD_DEVIATION 3.16
Hip Circumference	109.80 cm STANDARD_DEVIATION 7.15	106.14 cm STANDARD_DEVIATION 12.84	100.26 cm STANDARD_DEVIATION 11.01	118.36 cm STANDARD_DEVIATION 14.85	99.08 cm STANDARD_DEVIATION 7.24
Patient-Determined Disability Score	1.89 scores on a scale STANDARD_DEVIATION 1.54	2.21 scores on a scale STANDARD_DEVIATION 1.82	3.00 scores on a scale STANDARD_DEVIATION 2.14	1.09 scores on a scale STANDARD_DEVIATION 1.62	2.58 scores on a scale STANDARD_DEVIATION 1.56
Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue-MS Score	22.94 scores on a scale STANDARD_DEVIATION 7.67	21.91 scores on a scale STANDARD_DEVIATION 8.05	20.96 scores on a scale STANDARD_DEVIATION 9.46	21.40 scores on a scale STANDARD_DEVIATION 9.3	22.50 scores on a scale STANDARD_DEVIATION 6.49
Pittsburgh Sleep Quality Index Score	6.56 scores on a scale STANDARD_DEVIATION 4.22	7.79 scores on a scale STANDARD_DEVIATION 4.74	8.17 scores on a scale STANDARD_DEVIATION 4.76	8.50 scores on a scale STANDARD_DEVIATION 4.56	7.75 scores on a scale STANDARD_DEVIATION 5.96
Quality of Life	162.49 scores on a scale STANDARD_DEVIATION 34.24	156.02 scores on a scale STANDARD_DEVIATION 40.72	144.86 scores on a scale STANDARD_DEVIATION 49.44	174.73 scores on a scale STANDARD_DEVIATION 38.05	145.81 scores on a scale STANDARD_DEVIATION 36.48
Race/Ethnicity, Customized African American	0 Participants	11 Participants	4 Participants	3 Participants	4 Participants
Race/Ethnicity, Customized Asian	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Race/Ethnicity, Customized Non-White Hispanic	1 Participants	2 Participants	0 Participants	1 Participants	0 Participants
Race/Ethnicity, Customized Other	1 Participants	2 Participants	1 Participants	0 Participants	0 Participants
Race/Ethnicity, Customized White	7 Participants	28 Participants	7 Participants	6 Participants	8 Participants
Region of Enrollment United States	9 participants	43 participants	12 participants	10 participants	12 participants
Rosenberg Self-Esteem Score	25.11 scores on a scale STANDARD_DEVIATION 2.42	23.83 scores on a scale STANDARD_DEVIATION 4.31	24.17 scores on a scale STANDARD_DEVIATION 2.69	21.65 scores on a scale STANDARD_DEVIATION 7.89	24.33 scores on a scale STANDARD_DEVIATION 1.56
Sex: Female, Male Female	7 Participants	37 Participants	10 Participants	10 Participants	10 Participants
Sex: Female, Male Male	2 Participants	6 Participants	2 Participants	0 Participants	2 Participants
Waist Circumference	102.16 cm STANDARD_DEVIATION 13.05	96.4 cm STANDARD_DEVIATION 16.68	89.38 cm STANDARD_DEVIATION 12.58	110.22 cm STANDARD_DEVIATION 19.31	87.58 cm STANDARD_DEVIATION 11.63
Weight	82.76 kg STANDARD_DEVIATION 16.89	76.91 kg STANDARD_DEVIATION 17.73	70.13 kg STANDARD_DEVIATION 16.06	92.58 kg STANDARD_DEVIATION 17.26	66.25 kg STANDARD_DEVIATION 8.12

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk
deaths Total, all-cause mortality	0 / 10	0 / 9	0 / 12	0 / 12
other Total, other adverse events	1 / 10	0 / 9	0 / 12	0 / 12
serious Total, serious adverse events	0 / 10	0 / 9	0 / 12	0 / 12

Outcome results

Primary

Adherence

Number of participants adhering to the prescribed dietary intervention at the end of the 6-month study period.