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Clinical Trials/NCT06450977
NCT06450977
Recruiting
Not Applicable

Remote Evaluation of MIND Diet

University of Illinois at Urbana-Champaign1 site in 1 country40 target enrollmentJune 7, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Multiple Sclerosis
Sponsor
University of Illinois at Urbana-Champaign
Enrollment
40
Locations
1
Primary Endpoint
Processing Speed
Status
Recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 7, 2024
End Date
December 31, 2026
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Naiman Khan

Associate Professor

University of Illinois at Urbana-Champaign

Eligibility Criteria

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

Outcomes

Primary Outcomes

Processing Speed

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

Digit Span from CANTAB online battery

Visual Processing

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

Match to Sample Visual Search from CANTAB online battery

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.

Information Processing

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

Rapid Visual Information Processing Task from CANTAB online battery

Memory

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

Spatial Working Memory from CANTAB online battery

Learning

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

Paired Associates Learning Task from CANTAB online battery

Secondary Outcomes

  • Refusal Rates(Throughout the recruitment process.)
  • Attrition rates(Throughout the intervention (weeks 1-12))
  • Retention rates(Throughout the intervention (weeks 1-12))
  • Adherence/Compliance Rates(Throughout the intervention (weeks 1-12))
  • Recruitment Rates(Throughout the recruitment process)
  • Participant Experience and Burden(Throughout the intervention (weeks 1-12))

Study Sites (1)

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