MIND Diet and Cognitive Function in Middle-aged and Older Adults
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cognitive Function
- Sponsor
- Zhejiang University
- Enrollment
- 1200
- Locations
- 1
- Primary Endpoint
- Change in 5-min Montreal Cognitive Assessment (MoCA) score
- Status
- Not yet recruiting
- Last Updated
- last year
Overview
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.
Investigators
Changzheng Yuan
Research Professor
Zhejiang University
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.
Outcomes
Primary Outcomes
Change in 5-min Montreal Cognitive Assessment (MoCA) score
Time Frame: 12 months
Cognitive function will be assessed using the MoCA at baseline and during follow-up.
Secondary Outcomes
- Change in 8-Item Alzheimer's Diseases Screening Tool (AD-8) score(12 months)
- Change in Mediterranean-Dietary Approach to Stop Hypertension (DASH) Intervention for Neurodegenerative Delay (MIND) diet score(12 months)
- Change in EuroQol Five Dimensions (EQ-5D) scale(12 months)