A Pragmatic Trial of Dietary Programs in People With Multiple Sclerosi
A Pragmatic Trial of Dietary Programs in People With Multiple Sclerosis
What it found
Results are posted in the registry, but without a statistical test of the main measure. See the numbers below.
What was tested
Treatment tested
- Frequent Patient Interaction
- Timing Restriction
Given to everyone in the trial
- LoseIt! Smartphone Application
Results by group
Adherence
Baseline and 6 months
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Calorie Restriction - Frequent Patient Communication | 2 Participants | 10 | |
| Calorie Restriction - Communication Standard of Care | 6 Participants | 9 | |
| Timing Restriction | 10 Participants | 12 | |
| No Diet Change | 12 Participants | 12 |
Calorie Restriction - Frequent Patient Communication
Calorie Restriction - Communication Standard of Care
Timing Restriction
No Diet Change
Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.
Safety
| Group | Participants at risk | Serious adverse events | Deaths |
|---|---|---|---|
| Calorie Restriction - Frequent Patient Communication | 10 | 0 (0.0%) | 0 |
| Calorie Restriction - Communication Standard of Care | 9 | 0 (0.0%) | 0 |
| Timing Restriction | 12 | 0 (0.0%) | 0 |
| No Diet Change | 12 | 0 (0.0%) | 0 |
As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.
What it measured
Main measures
Adherence
Baseline and 6 months
Quality of life (reported by participants)
Other measures (7)
Body Mass Index (BMI)
Baseline and 6 months
Weight Change
Baseline and 6 months
Weight Change Among Adherent Participants
Baseline and 6 months
Quality of life (reported by participants)Functional Assessment in MS Score
Baseline and 6 months
FatigueWalking and mobilityQuality of life (reported by participants)Fatigue
Baseline and 6 months
FatigueQuality of life (reported by participants)Sleep Quality
Baseline and 6 months
Mood and sleepSelf-esteem
Baseline and 6 months
Who could take part
MS (type not specified) · 18 to 75
Show the full criteria
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
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
This is a pragmatic, single-blinded randomized trial of improving adherence to dietary interventions in patients with MS who are receiving monthly natalizumab infusions.
Papers
Results
Safety and feasibility of various fasting-mimicking diets among people with multiple sclerosis.Mult Scler Relat Disord · 2020
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History
Started
Aug 2016
Main results due
Jun 2017
Finished
Jul 2017
Results posted
Jun 2018