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NCT Number: NCT06450977

Remote Evaluation of MIND Diet

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.

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Key information

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Illinois Urbana-Champaign

Urbana, Illinois, 61801, United States

Location status: Recruiting

Location contact

Naiman Khan, PhD/RD

CONTACT

About this 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Individuals aged 18-64 years old
  • Self-reported diagnosis of Multiple sclerosis (MS)
  • 20/20 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

Exclusion criteria

  • 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

Treatment and study plan

MIND Diet

Other

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

Control diet

Other

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

Primary outcomes

  1. Information Processing

    Time frame: 12 weeks (Baseline vs. Follow Up)

    Rapid Visual Information Processing Task from CANTAB online battery

  2. Visual Processing

    Time frame: 12 weeks (Baseline vs. Follow Up)

    Match to Sample Visual Search from CANTAB online battery

  3. Processing Speed

    Time frame: 12 weeks (Baseline vs. Follow Up)

    Digit Span from CANTAB online battery

  4. Learning

    Time frame: 12 weeks (Baseline vs. Follow Up)

    Paired Associates Learning Task from CANTAB online battery

  5. Memory

    Time frame: 12 weeks (Baseline vs. Follow Up)

    Spatial Working Memory from CANTAB online battery

  6. MIND Scores

    Time frame: 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.

Secondary outcomes

  1. Recruitment Rates

    Time frame: Throughout the recruitment process

    Measure the number of participants contacted and interested in participating in the study

  2. Refusal Rates

    Time frame: 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.

  3. Retention rates

    Time frame: Throughout the intervention (weeks 1-12)

    Retention will be described as the proportion of enrolled participants who complete the intervention

  4. Attrition rates

    Time frame: Throughout the intervention (weeks 1-12)

    Attrition is the proportion of the participants who did not complete the intervention.

  5. Adherence/Compliance Rates

    Time frame: 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.

  6. Participant Experience and Burden

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Naiman Khan, PhD

CONTACT

[email protected]

2173001667

Sponsors and collaborators

Lead sponsor

University of Illinois at Urbana-Champaign

Other

Registry information

Acronym: REMIND

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jun 10, 2024
Registry last updated
Jun 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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