MIND Diet to Improve Cognitive Function in Mild Stroke Patients

NCT05921084 | Active Not Recruiting

• 1 other identifier: 20230520
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

A 6-month pilot randomized controlled trial designed to test the effect of the Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND) Diet + usual medical care versus usual medical care on the rate of cognitive change and several other secondary outcomes through a randomized controlled trial in 60 mild stroke patients aged 35-70 years without dementia.

Conditions

Dementia; Cognitive Change; Stroke; Cerebral Infarction; Transient Ischemic Attack

Keywords

Cognitive function; Dietary pattern

Outcome Measures

Primary Outcomes (2)

• Change in global cognitive function

  Global cognitive function assessment is based on a battery of cognitive tests. Individual test scores will be summarized by calculating the z-score for each test based on the mean and standard deviation of the sample distribution - averaging z-scores across tests will yield a composite score for global cognitive function. Cognitive function will be assessed at the baseline, 3, and 6 months to determine cognitive change.

  6 months

• Change in MIND diet score

  Dietary behavior will be assessed using food frequency questionnaire (FFQ). A 15-point MIND diet score will be calculated to reflect the MIND diet adherence among both groups of participants.

  6 months

Secondary Outcomes (7)

• Change in Montreal Cognitive Assessment (MoCA) and Mini-Mental State Examination (MMSE) scores

  6 months

• Change in memory function

  6 months

• Change in language function

  6 months

• Change in executive function

  6 months

• Change in visuospatial function

  6 months

Other Outcomes (8)

• Change in dietary behaviour measured using a food frequency questionnaire

  6 months

• Change in the ability of daily life measured using the Activities of Daily Living Scale (ADL)

  6 months

• Change in the ability of daily life measured using the Instrumental Activities of Daily Living Scale (IADL)

  6 months

Study Arms (2)

Control arm

PLACEBO COMPARATOR

Usual medical care (including general dietary advice).

Behavioral: General dietary advice

MIND diet intervention arm

ACTIVE COMPARATOR

Usual medical care plus the MIND diet intervention.

Behavioral: MIND diet intervention

Interventions

MIND diet intervention BEHAVIORAL

The MIND diet intervention, composed of the consumption of whole grains, dark green leafy vegetables, dark red/yellow vegetables, other vegetables, berries and citrus, poultry, fish and seafoods, beans and legume, nuts, olive and seed oils, and green tea, and restricting red and processed meats, animal fat, fried foods, and sweets and pastries.

MIND diet intervention arm

General dietary advice BEHAVIORAL

General dietary advice

Control arm

Eligibility Criteria

• Age: 35 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinically confirmed new cerebral infarction, onset hospitalization time ≤14 days
• NHISS score of 0-6, with no difficulty in autonomous eating or aphasia
• Baseline MMSE score being 16-25/30 points or MoCA score ≤24/30 points
• Baseline MIND dietary pattern screening scale score ≤10/15 points
• Body mass index no less than 18.0 kg/m2
• Normal chewing function, able to eat hard foods such as nuts
• Willing to participate and sign an informed consent form
• Agree not to take over-the-counter nutritional supplements during the trial period
• Able to understand research procedures and adhere to them throughout the entire study period
• completed the run-in test

You may not qualify if:

• Diagnosis of dementia at a county-level or above hospital before the stroke or suspected to have pre-stroke dementia from the informant interview administered by a neurologist.
• Participation in or have participated in other clinical trial studies within the past year
• Allergies to foods involved in the experiment (nuts, berries, olive oil, or fish, etc.) or using drugs not compatible with foods involved.
• Medication to treat Alzheimer's or Parkinson's disease
• Diagnosis of cancer, severe liver and kidney disease, or current life expectancy less than 3 years
• Diagnosis of depression, bipolar disorder, or other mental illnesses
• Pregnancy or breastfeeding or with a pregnancy plan
• Diagnosis of inflammatory bowel disease or other malabsorption-related gastrointestinal diseases
• History of alcohol or drug abuse

Sponsors & Collaborators

• Zhejiang University: lead
• Second Affiliated Hospital, School of Medicine, Zhejiang University: collaborator

Study Sites (1)

Second Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310058, China

Location

Related Publications (4)

• Chen H, Dhana K, Huang Y, Huang L, Tao Y, Liu X, Melo van Lent D, Zheng Y, Ascherio A, Willett W, Yuan C. Association of the Mediterranean Dietary Approaches to Stop Hypertension Intervention for Neurodegenerative Delay (MIND) Diet With the Risk of Dementia. JAMA Psychiatry. 2023 Jun 1;80(6):630-638. doi: 10.1001/jamapsychiatry.2023.0800.

  PMID: 37133875 BACKGROUND

• Huang L, Tao Y, Chen H, Chen X, Shen J, Zhao C, Xu X, He M, Zhu D, Zhang R, Yang M, Zheng Y, Yuan C. Mediterranean-Dietary Approaches to Stop Hypertension Intervention for Neurodegenerative Delay (MIND) Diet and Cognitive Function and its Decline: A Prospective Study and Meta-analysis of Cohort Studies. Am J Clin Nutr. 2023 Jul;118(1):174-182. doi: 10.1016/j.ajcnut.2023.04.025. Epub 2023 Apr 25.

  PMID: 37105521 BACKGROUND

• Morris MC, Tangney CC, Wang Y, Sacks FM, Barnes LL, Bennett DA, Aggarwal NT. MIND diet slows cognitive decline with aging. Alzheimers Dement. 2015 Sep;11(9):1015-22. doi: 10.1016/j.jalz.2015.04.011. Epub 2015 Jun 15.

  PMID: 26086182 BACKGROUND

• Liu X, Morris MC, Dhana K, Ventrelle J, Johnson K, Bishop L, Hollings CS, Boulin A, Laranjo N, Stubbs BJ, Reilly X, Carey VJ, Wang Y, Furtado JD, Marcovina SM, Tangney C, Aggarwal NT, Arfanakis K, Sacks FM, Barnes LL. Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND) study: Rationale, design and baseline characteristics of a randomized control trial of the MIND diet on cognitive decline. Contemp Clin Trials. 2021 Mar;102:106270. doi: 10.1016/j.cct.2021.106270. Epub 2021 Jan 9.

  PMID: 33434704 BACKGROUND

MeSH Terms

Conditions

Dementia; Stroke; Cerebral Infarction; Ischemic Attack, Transient

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Cerebrovascular Disorders; Vascular Diseases; Cardiovascular Diseases; Brain Infarction; Brain Ischemia; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Changzheng Yuan, ScD

  Zhejiang University School of Medicine

  PRINCIPAL INVESTIGATOR

• Lusha Tong, PhD

  Second Affiliated Hospital, School of Medicine, Zhejiang University

  PRINCIPAL INVESTIGATOR

• Xin Xu, PhD

  Zhejiang University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: This is a single-blind design, where the outcome assessors will be masked from the assignment of the participants.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: This is a two-arm parallel design, with one arm being the control arm (usual medical care) and the other being the intervention arm (MIND diet intervention + usual medical care).

Study Record Dates

• First Submitted: June 1, 2023
• First Posted: June 27, 2023
• Study Start: July 23, 2023
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2025
• Last Updated: March 19, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)