Remote Evaluation of MIND Diet (REMIND)

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.

Study Overview

• Status: Recruiting
• Conditions: Multiple Sclerosis; Cognitive Change; Nutrition, Healthy
• Intervention / Treatment: Other: MIND Diet; Other: Control Diet

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 Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Naiman Khan, PhD; Phone Number: 2173001667; Email: nakhan2@illinois.edu

Study Locations

• United States
  • Illinois
    • Urbana, Illinois, United States, 61801
      • Recruiting
      • University of Illinois Urbana-Champaign
      • Contact: Naiman Khan, PhD/RD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: MIND Diet; Daily meals designed to increase adherence to the Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND) dietary pattern.
Active Comparator: 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).	Other: Control Diet; Daily meals designed to increase fruit, vegetable, and whole grain intake consistent with a healthy American diet.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Information Processing	Rapid Visual Information Processing Task from CANTAB online battery	12 weeks (Baseline vs. Follow Up)
Visual Processing	Match to Sample Visual Search from CANTAB online battery	12 weeks (Baseline vs. Follow Up)
Processing Speed	Digit Span from CANTAB online battery	12 weeks (Baseline vs. Follow Up)
Learning	Paired Associates Learning Task from CANTAB online battery	12 weeks (Baseline vs. Follow Up)
Memory	Spatial Working Memory from CANTAB online battery	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.	12 weeks (Baseline vs. Follow Up)

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Illinois at Urbana-Champaign
• Investigators: Principal Investigator: Naiman Khan, PhD, University of Illinois Urbana-Champaign

Study record dates

Study Major Dates

• Study Start (Actual): June 7, 2024
• Primary Completion (Estimated): January 1, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: June 4, 2024
• First Submitted That Met QC Criteria: June 4, 2024
• First Posted (Actual): June 10, 2024

Study Record Updates

• Last Update Posted (Actual): June 27, 2024
• Last Update Submitted That Met QC Criteria: June 25, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: MIND; Telehealth; Executive Function; Dietary Pattern
• Additional Relevant MeSH Terms: Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis
• Other Study ID Numbers: REMIND

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No