MIND Diet to Improve Cognitive Function in Mild Stroke Patients (MINDICOMS) II

NCT ID: NCT06331247

Last Updated: 2024-04-04

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-18
• Study Completion Date: 2025-12-31

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 cognitive change and several other secondary outcomes through a randomized controlled trial in 60 mild stroke patients aged 35-70 years without dementia.

Detailed Description

Mediterranean-DASH (Dietary Approach to Stop Hypertension) Intervention for Neurodegenerative Delay (MIND) Diet and Cognitive Decline in Mild Stroke Patients (MINDICOMS) II is a 6-month pilot randomized controlled trial designed to test the effects of the MIND diet on cognitive change and several other secondary outcomes among 60 individuals aged 35-70 years without dementia. The proposed MIND diet for this study is a hybrid of the Mediterranean and DASH diets but with selected modifications based on the most compelling evidence in the diet-dementia field and Chinese Dietary Guidelines 2022. Specifically, the proposed MIND diet will emphasize the consumption of whole grains, dark green leafy vegetables, dark red/yellow vegetables, other vegetables, berries and citrus, poultry, fish and seafood, beans and legume, nuts, olive and seed oils, and green tea, and restrict red and processed meats, animal fat, fried foods, and sweets and pastries. The trial will employ a parallel group design comparing the effects on global cognitive change of the MIND intervention diet to usual medical care among 60 mild stroke patients aged 35-70 years. Secondary outcomes will include cognitive function changes in several domains, brain imaging marker changes, dietary behaviour changes, daily living behaviour ability changes, mental health changes, and plasma biomarker changes. In addition, this trial will examine potential effect mediators and modifiers. The proposed study is sited at the Bo'Ao District, Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou. Specialized laboratories will conduct biochemical analyses.

Conditions

Dementia; Stroke; Cognitive Change; Cerebrovascular; Disorder, Thrombotic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Control arm

Usual medical care (including general dietary advice).

Group Type: PLACEBO_COMPARATOR

General dietary advice

Intervention Type: BEHAVIORAL

General dietary advice according to the Chinese Dietary Guidelines 2022.

Routine medical care

Intervention Type: OTHER

Routine medical care and follow-ups.

MIND diet intervention arm

Usual medical care (including general dietary advice) plus the MIND diet intervention.

Group Type: ACTIVE_COMPARATOR

General dietary advice

Intervention Type: BEHAVIORAL

General dietary advice according to the Chinese Dietary Guidelines 2022.

Localized MIND diet intervention

Intervention Type: 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.

Routine medical care

Intervention Type: OTHER

Routine medical care and follow-ups.

Interventions

General dietary advice

General dietary advice according to the Chinese Dietary Guidelines 2022.

Intervention Type: BEHAVIORAL

Localized MIND diet intervention

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.

Intervention Type: BEHAVIORAL

Routine medical care

Routine medical care and follow-ups.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Clinically confirmed new cerebral infarction, onset hospitalization time ≤14 days
• National Institutes of Health Stroke Scale (NIHSS) 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, with signs of post-stroke cognitive decline
• 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

Exclusion Criteria

• 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 6 months
• 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

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Changzheng Yuan

Research Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Changzheng Yuan, ScD

Role: PRINCIPAL_INVESTIGATOR

Second Affiliated Hospital, Zhejiang University School of Medicine

Lusha Tong, MD

Role: PRINCIPAL_INVESTIGATOR

Second Affiliated Hospital, Zhejiang University School of Medicine

Xin Xu, PhD

Role: PRINCIPAL_INVESTIGATOR

Zhejiang University School of Medicine

Locations

Second Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

Changzheng Yuan, ScD

Role: CONTACT

chy478@zju.edu.cn

8617326860291

Facility Contacts

Lusha Tong, PhD

Role: primary

Other Identifiers

20230520-2

Identifier Type: -

Identifier Source: org_study_id