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

Dementia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06417749
• Other study ID #: LL20240353
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 10, 2024
• Est. completion date: October 10, 2025

Study information

• Verified date: May 2024
• Source: Zhejiang University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1200
• Est. completion date: October 10, 2025
• Est. primary completion date: May 10, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 69 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cognitive Function
• Dementia

Intervention

Behavioral:
• Control arm
Participants will receive a copy of the Chinese Dietary Guidelines leaflet at baseline.
• Intervention arm
Participants will be given three MIND diet education videos on different topics at baseline and during follow-up. In addition, each participant will receive a MIND diet education brochure at baseline and some food supply during follow-up.

Locations

Country	Name	City	State
China	Mutiple Counties	Taian	Shandong

Sponsors (2)

Lead Sponsor	Collaborator
Zhejiang University	Shandong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in 5-min Montreal Cognitive Assessment (MoCA) score	Cognitive function will be assessed using the MoCA at baseline and during follow-up.	12 months
Secondary	Change in EuroQol Five Dimensions (EQ-5D) scale	The 5-level EQ-5D (EQ-5D-5L) will be used to assess life quality. Evaluations will be conducted at baseline and during follow-up.	12 months
Secondary	Change in 8-Item Alzheimer's Diseases Screening Tool (AD-8) score	AD-8 will be used to assess cognitive function. Evaluations will be conducted at baseline and during follow-up.	12 months
Secondary	Change in Mediterranean-Dietary Approach to Stop Hypertension (DASH) Intervention for Neurodegenerative Delay (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. Evaluations will be conducted at baseline and during follow-up.	12 months