Remote Evaluation of MIND Diet

NCT06450977 | Recruiting

• 1 other identifier: REMIND
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis; Cognitive Change; Nutrition, Healthy

Keywords

Executive Function; MIND; Dietary Pattern; Telehealth

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (6)

• Recruitment Rates

  Throughout the recruitment process

• Refusal Rates

  Throughout the recruitment process.

• Retention rates

  Throughout the intervention (weeks 1-12)

• Attrition rates

  Throughout the intervention (weeks 1-12)

• Adherence/Compliance Rates

  Throughout the intervention (weeks 1-12)

Study Arms (2)

MIND Diet

EXPERIMENTAL

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

Control Diet

ACTIVE COMPARATOR

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

Interventions

MIND Diet OTHER

Daily meals designed to increase adherence to the Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND) dietary pattern.

MIND Diet

Control Diet OTHER

Daily meals designed to increase fruit, vegetable, and whole grain intake consistent with a healthy American diet.

Control Diet

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Individuals aged 18-64 years old
• Self-reported diagnosis of Multiple sclerosis (MS)
• /20 or corrected vision
• No other neurodegenerative disease diagnosis
• Stable disease-modifying therapy (DMT) within 6 months
• Not Pregnant or lactating
• No food allergies or intolerances
• Able to consume study meals
• Not enrolled in another dietary, exercise, or medication study during the study
• Access to a computer/laptop with internet

You may not qualify if:

• Individuals younger than 18 or older than 64 years old
• No self-reported diagnosis of Multiple sclerosis (MS)
• Not 20/20 or uncorrected vision
• Other neurodegenerative disease diagnosis
• Disease modifying therapy (DMT) less than 6 months
• Pregnant or lactating
• Food allergies or intolerances
• Not able to consume study meals
• Enrolled in another dietary, exercise, or medication study during the study
• No access to a computer/laptop with internet

Sponsors & Collaborators

• University of Illinois at Urbana-Champaign: lead

Study Sites (1)

University of Illinois Urbana-Champaign

Urbana, Illinois, 61801, United States

RECRUITING

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Naiman Khan, PhD

  University of Illinois Urbana-Champaign

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Naiman Khan, PhD

CONTACT

2173001667; nakhan2@illinois.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 4, 2024
• First Posted: June 10, 2024
• Study Start: June 7, 2024
• Primary Completion: January 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: June 27, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)