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

Not Applicable

Not yet recruiting

• Conditions: Cognitive Function; Dementia

• Registration Number: NCT06417749
• Lead Sponsor: Zhejiang University

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.

Study Timeline

• Status Verified: 2024-05
• Study Start: 2024-05-10
• Study First Submitted: 2024-05-12
• Study First Submitted QC: 2024-05-12
• Last Update Submitted: 2024-05-12
• Study First Posted: 2024-05-16
• Last Update Posted: 2024-05-16
• Primary Completion: 2025-05-10
• Study Completion: 2025-10-10

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 1200

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in 5-min Montreal Cognitive Assessment (MoCA) score	12 months	Cognitive function will be assessed using the MoCA at baseline and during follow-up.

Secondary Outcome Measures

Name	Time	Method
Change in Mediterranean-Dietary Approach to Stop Hypertension (DASH) Intervention for Neurodegenerative Delay (MIND) diet score	12 months	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.
Change in EuroQol Five Dimensions (EQ-5D) scale	12 months	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.
Change in 8-Item Alzheimer's Diseases Screening Tool (AD-8) score	12 months	AD-8 will be used to assess cognitive function. Evaluations will be conducted at baseline and during follow-up.

Trial Locations

Locations (1)

Mutiple Counties; 🇨🇳 Taian, Shandong, China