An interventional study of MIND Diet and Control Diet in Multiple Sclerosis, Cognitive Change and Nutrition, Healthy, sponsored by University of Illinois at Urbana-Champaign. Recruiting at 1 site in United States. Open to participants aged 18 Years to 64 Years. Per ClinicalTrials.gov, last updated 2024-06-27.
Sponsored by University of Illinois at Urbana-Champaign · Not applicable, Interventional, and Supportive care
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.
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.
3,524 studies on the registry are indexed under Multiple Sclerosis; 668 are open to participants now.
This study's planned enrollment of 40 is below the median of 50 across 2,386 interventional studies indexed under Multiple Sclerosis.
Browse Multiple Sclerosis studies →University of Illinois at Urbana-Champaign is the lead sponsor of 191 studies on the registry; 29 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Participants in the active MIND diet group will be asked to consume one ready-to-eat meal per day from Daily Harvest® meal delivery service. The treatment meals will follow MIND diet guidelines and include leafy green vegetables, nuts, legumes, whole grains, berries, and extra virgin olive oil.
Other: MIND Diet
Participants in the control diet group will be asked to consume one ready-to-eat meal per day from Daily Harvest® meal delivery service. The Control group will receive daily meals that are isocaloric with the active/experimental meals but will follow a general diet based on the average American diet and Dietary Guidelines for Americans (i.e., vegetables, fruits, nuts, whole grains, and unsaturated fats).
Other: Control Diet
Daily meals designed to increase adherence to the Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND) dietary pattern.
Daily meals designed to increase fruit, vegetable, and whole grain intake consistent with a healthy American diet.
Information Processing
Rapid Visual Information Processing Task from CANTAB online battery
Time frame: 12 weeks (Baseline vs. Follow Up)
Visual Processing
Match to Sample Visual Search from CANTAB online battery
Time frame: 12 weeks (Baseline vs. Follow Up)
Processing Speed
Digit Span from CANTAB online battery
Time frame: 12 weeks (Baseline vs. Follow Up)
Learning
Paired Associates Learning Task from CANTAB online battery
Time frame: 12 weeks (Baseline vs. Follow Up)
Memory
Spatial Working Memory from CANTAB online battery
Time frame: 12 weeks (Baseline vs. Follow Up)
MIND Scores
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.
Time frame: 12 weeks (Baseline vs. Follow Up)
Recruitment Rates
Measure the number of participants contacted and interested in participating in the study
Time frame: Throughout the recruitment process
Refusal Rates
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.
Time frame: Throughout the recruitment process.
Retention rates
Retention will be described as the proportion of enrolled participants who complete the intervention
Time frame: Throughout the intervention (weeks 1-12)
Attrition rates
Attrition is the proportion of the participants who did not complete the intervention.
Time frame: Throughout the intervention (weeks 1-12)
Adherence/Compliance Rates
Adherence rates are the proportion of intervention meals and guidelines the participants followed. These will be tracked through tracking surveys throughout the intervention.
Time frame: Throughout the intervention (weeks 1-12)
Participant Experience and Burden
Participants will report feedback on the intervention through video chats. Descriptives of participant experience and burden of intervention will be reported
Time frame: Throughout the intervention (weeks 1-12)
Plan to share: No
Started Jun 2024 (actual). Primary completion is estimated for Jan 2026, 18 months after the start.
Of 868 non-industry interventional studies with no phase under Multiple Sclerosis, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 43. This study's planned 18 months is below that.
Counting every sponsor, half of 889 studies reached it within 21 months; a quarter within 9 and three quarters within 43.
How these figures are worked out, and which studies are left out of them.
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