Cognitive Function, Dementia
Conditions
Keywords
Cognitive Function, Dietary Pattern
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.
Interventions
BEHAVIORALControl arm
Participants will receive a copy of the Chinese Dietary Guidelines leaflet at baseline.
BEHAVIORALIntervention 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.
Sponsors
Shandong University
Zhejiang University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Masking description
This is a single-blind design, where the outcome assessors will be masked from the assignment of the participants.
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).
Eligibility
Sex/Gender
ALL
Age
40 Years to 69 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Countries
China
Outcome results
None listed