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

NCT06417749 | Not Yet Recruiting

• 1 other identifier: LL20240353
• Study Type: interventional
• Target: 1,200
• Locations: 1 country
• Sites: 1

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.

Conditions

Cognitive Function; Dementia

Keywords

Cognitive Function; Dietary Pattern

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change in EuroQol Five Dimensions (EQ-5D) scale

  12 months

• 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

Study Arms (2)

Control arm

PLACEBO COMPARATOR

General dietary advice

Behavioral: Control arm

Intervention arm

ACTIVE COMPARATOR

MIND diet education

Behavioral: Intervention arm

Interventions

Control arm BEHAVIORAL

Participants will receive a copy of the Chinese Dietary Guidelines leaflet at baseline.

Control arm

Intervention arm BEHAVIORAL

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.

Intervention arm

Eligibility Criteria

• Age: 40 Years - 69 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zhejiang University: lead
• Shandong University: collaborator

Study Sites (1)

Mutiple Counties

Taian, Shandong, 271000, China

Location

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: This is a single-blind design, where the outcome assessors will be masked from the assignment of the participants.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Professor

Model Details: 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).

Study Record Dates

• First Submitted: May 12, 2024
• First Posted: May 16, 2024
• Study Start: May 10, 2024
• Primary Completion: May 10, 2025
• Study Completion: October 10, 2025
• Last Updated: May 16, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)