Multiple Sclerosis, Cognitive Change, Nutrition, Healthy
Conditions
Keywords
Executive Function, MIND, Dietary Pattern, Telehealth
Brief summary
The goal of this clinical trial is to learn if increasing adherence to a Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND) diet pattern improves thinking ability and memory compared to a healthy control diet in persons with Multiple Sclerosis (MS). The main question it aims to answer is: Does the MIND diet improve cognitive performance relative to a control diet in persons with MS? Participants will: Consume one meal that follows the MIND diet or a control meal every day for 3 months, complete online surveys and cognitive testing before and after, and keep a record of the food they eat during the study.
Detailed description
The purpose of this study is to understand how a healthy diet is related to thinking ability and memory in people with multiple sclerosis (MS). This study is fully remote consisting of meals being delivered to participant homes using Daily Harvest meal delivery service. Participants will be asked to consume a microwaveable study meal or prepackaged smoothie every day for 12 weeks. The study meals and smoothies will follow either a dietary pattern thought to improve brain health (Mediterranean-DASH Intervention for Neurodegenerative Delay; MIND), or a control diet, and will include foods commonly found in grocery stores. Participants will not know which diet they are assigned to (active or control). Participants will also be asked to follow simple dietary guidance on a healthy diet in addition to the meals provided. Participants will complete a series of online forms or surveys. Additionally, participants will complete an online cognitive battery from Cambridge Neuropsychological Test Automated Battery (CANTAB) at the beginning and end of the study.
Interventions
OTHERMIND Diet
Daily meals designed to increase adherence to the Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND) dietary pattern.
OTHERControl Diet
Daily meals designed to increase fruit, vegetable, and whole grain intake consistent with a healthy American diet.
Sponsors
University of Illinois at Urbana-Champaign
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
1. Individuals aged 18-64 years old 2. Self-reported diagnosis of Multiple sclerosis (MS) 3. 20/20 or corrected vision 4. No other neurodegenerative disease diagnosis 5. Stable disease-modifying therapy (DMT) within 6 months 6. Not Pregnant or lactating 7. No food allergies or intolerances 8. Able to consume study meals 9. Not enrolled in another dietary, exercise, or medication study during the study 10. Access to a computer/laptop with internet
Exclusion criteria
1. Individuals younger than 18 or older than 64 years old 2. No self-reported diagnosis of Multiple sclerosis (MS) 3. Not 20/20 or uncorrected vision 4. Other neurodegenerative disease diagnosis 5. Disease modifying therapy (DMT) less than 6 months 6. Pregnant or lactating 7. Food allergies or intolerances 8. Not able to consume study meals 9. Enrolled in another dietary, exercise, or medication study during the study 10. No access to a computer/laptop with internet
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| MIND Scores | 12 weeks (Baseline vs. Follow Up) | MIND dietary pattern scores calculated from diet records/surveys. Validated score to determine how someone adheres to the dietary pattern, scale of 0 to 14 with a higher score indicating greater adherence to the pattern. |
| Information Processing | 12 weeks (Baseline vs. Follow Up) | Rapid Visual Information Processing Task from CANTAB online battery |
| Visual Processing | 12 weeks (Baseline vs. Follow Up) | Match to Sample Visual Search from CANTAB online battery |
| Processing Speed | 12 weeks (Baseline vs. Follow Up) | Digit Span from CANTAB online battery |
| Learning | 12 weeks (Baseline vs. Follow Up) | Paired Associates Learning Task from CANTAB online battery |
| Memory | 12 weeks (Baseline vs. Follow Up) | Spatial Working Memory from CANTAB online battery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Recruitment Rates | Throughout the recruitment process | Measure the number of participants contacted and interested in participating in the study |
| Refusal Rates | Throughout the recruitment process. | Measure the number of participants that refused to participate in the intervention. Data on refusal factors will be collected through emails and calls and summarized. |
| Retention rates | Throughout the intervention (weeks 1-12) | Retention will be described as the proportion of enrolled participants who complete the intervention |
| Attrition rates | Throughout the intervention (weeks 1-12) | Attrition is the proportion of the participants who did not complete the intervention. |
| Adherence/Compliance Rates | Throughout the intervention (weeks 1-12) | Adherence rates are the proportion of intervention meals and guidelines the participants followed. These will be tracked through tracking surveys throughout the intervention. |
| Participant Experience and Burden | Throughout the intervention (weeks 1-12) | Participants will report feedback on the intervention through video chats. Descriptives of participant experience and burden of intervention will be reported |
Countries
United States
Contacts
Primary ContactNaiman Khan, PhD
Outcome results
None listed