Clinical trial NCT06450977: Remote Evaluation of MIND Diet
Official title: Remote Evaluation of MIND Diet
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Multiple Sclerosis
Cognitive Change
Nutrition, Healthy
Keywords: Executive Function
MIND
Dietary Pattern
Telehealth
Lead sponsor: University of Illinois at Urbana-Champaign
Sponsor class: OTHER
First posted: 2024-06-10
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Information Processing
timeFrame: 12 weeks (Baseline vs. Follow Up)
measure: Visual Processing
timeFrame: 12 weeks (Baseline vs. Follow Up)
measure: Processing Speed
timeFrame: 12 weeks (Baseline vs. Follow Up)
measure: Learning
timeFrame: 12 weeks (Baseline vs. Follow Up)
measure: Memory
timeFrame: 12 weeks (Baseline vs. Follow Up)
measure: MIND Scores
timeFrame: 12 weeks (Baseline vs. Follow Up)
Secondary outcomes:
measure: Recruitment Rates
timeFrame: Throughout the recruitment process
measure: Refusal Rates
timeFrame: Throughout the recruitment process.
measure: Retention rates
timeFrame: Throughout the intervention (weeks 1-12)
measure: Attrition rates
timeFrame: Throughout the intervention (weeks 1-12)
measure: Adherence/Compliance Rates
timeFrame: Throughout the intervention (weeks 1-12)
measure: Participant Experience and Burden
timeFrame: Throughout the intervention (weeks 1-12)
Other outcomes:
Locations:
city: Urbana
country: United States
facility: University of Illinois Urbana-Champaign
state: Illinois
Study officials:
affiliation: University of Illinois Urbana-Champaign
name: Naiman Khan, PhD
role: PRINCIPAL_INVESTIGATOR
References: