Remote Evaluation of MIND Diet

Not Applicable

Recruiting

• Conditions: Multiple Sclerosis; Cognitive Change; Nutrition, Healthy
• Interventions: Other: MIND Diet; Other: Control Diet

• Registration Number: NCT06450977
• Lead Sponsor: University of Illinois at Urbana-Champaign

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.

Study Timeline

• Status Verified: 2024-06
• Study First Submitted: 2024-06-04
• Study First Submitted QC: 2024-06-04
• Study Start: 2024-06-07
• Study First Posted: 2024-06-10
• Last Update Submitted: 2024-06-25
• Last Update Posted: 2024-06-27
• Primary Completion: 2026-01-01
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MIND Diet	MIND Diet	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.
Control Diet	Control 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).

Primary Outcome Measures

Name	Time	Method
Processing Speed	12 weeks (Baseline vs. Follow Up)	Digit Span from CANTAB online battery
Visual Processing	12 weeks (Baseline vs. Follow Up)	Match to Sample Visual Search from CANTAB online battery
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
Memory	12 weeks (Baseline vs. Follow Up)	Spatial Working Memory from CANTAB online battery
Learning	12 weeks (Baseline vs. Follow Up)	Paired Associates Learning Task from CANTAB online battery

Secondary Outcome Measures

Name	Time	Method
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.
Attrition rates	Throughout the intervention (weeks 1-12)	Attrition is the proportion of the participants who did not complete the intervention.
Retention rates	Throughout the intervention (weeks 1-12)	Retention will be described as the proportion of enrolled participants who 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.
Recruitment Rates	Throughout the recruitment process	Measure the number of participants contacted and interested in participating in the study
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

Trial Locations

Locations (1)

University of Illinois Urbana-Champaign; 🇺🇸 Urbana, Illinois, United States