Clinical trial NCT06417749: MIND Diet and Cognitive Function in Middle-aged and Older Adults
Official title: MIND Diet and Cognitive Function in Middle-aged and Older Adults
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cognitive Function
Dementia
Keywords: Cognitive Function
Dietary Pattern
Lead sponsor: Zhejiang University
Sponsor class: OTHER
Collaborators: name: Shandong University
First posted: 2024-05-16
Enrollment: 1200
Sex: ALL
Minimum age (years): 40
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a two-arm parallel design, with one arm being the control arm and the other being the intervention arm (MIND diet education and food supply).
Primary purpose: PREVENTION

Brief summary: A 12-month cluster-randomized controlled trial designed to test the effect of the Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND) diet education on the rate of cognitive change and several other secondary outcomes in 1200 adults aged 40-69 years.

Detailed description: Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND) Diet and Cognitive Decline in Middle-aged and Elderly People is a 12-month cluster-randomized controlled trial designed to test the effect of the Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND) diet education on the rate of cognitive change and several other secondary outcomes in 1200 adults aged 40-69 years. 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 education 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 legumes, 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 cluster randomization design comparing the effects on cognitive change of the MIND intervention diet education among 1200 adults aged 40-69 years. Secondary outcomes will include dietary behavior changes, health status changes, etc. The proposed study is sited at Taian, Shandong, China.

Eligibility criteria: Inclusion Criteria:

* Normal chewing function, able to eat hard foods such as nuts.
* Willing to participate and sign an informed consent form.
* Able to understand research procedures and adhere to them throughout the entire study period.

Exclusion Criteria:

* Participation in or have participated in other clinical trial studies within the past year.
* Medication to treat Alzheimer's or Parkinson's disease.
* Diagnosis of severe chronic diseases, such as cancer.

Primary outcomes:
measure: Change in 5-min Montreal Cognitive Assessment (MoCA) score
timeFrame: 12 months
Secondary outcomes:
measure: Change in EuroQol Five Dimensions (EQ-5D) scale
timeFrame: 12 months
measure: Change in 8-Item Alzheimer's Diseases Screening Tool (AD-8) score
timeFrame: 12 months
measure: Change in Mediterranean-Dietary Approach to Stop Hypertension (DASH) Intervention for Neurodegenerative Delay (MIND) diet score
timeFrame: 12 months
Other outcomes:
Locations:
city: Taian
country: China
facility: Mutiple Counties
state: Shandong
Study officials:
References: