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MIND Diet and Cognitive Function in Middle-aged and Older Adults

Zhejiang University logo

Zhejiang University

Status

Not yet enrolling

Conditions

Cognitive Function
Dementia

Treatments

Behavioral: Intervention arm
Behavioral: Control arm

Study type

Interventional

Funder types

Other

Identifiers

NCT06417749
LL20240353

Details and patient eligibility

About

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.

Full 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.

Enrollment

1,200 estimated patients

Sex

All

Ages

40 to 69 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

1,200 participants in 2 patient groups, including a placebo group

Control arm
Placebo Comparator group
Description:
General dietary advice
Treatment:
Behavioral: Control arm
Intervention arm
Active Comparator group
Description:
MIND diet education
Treatment:
Behavioral: Intervention arm

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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