Effects of Mediterranean Diet on Subjective Cognitive Decline

NCT06287489 | Completed

• 1 other identifier: No.:2023-08-010ACF
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

Brief Summary

Research Questions:

1. 1.Due to the fact that most participants in past clinical trials on the Mediterranean diet were cognitively healthy individuals, and while the observed effects were significant, they were not particularly substantial, does the Mediterranean diet have similarly significant and more pronounced effects on both physical and cognitive functions in older adults with subjective cognitive decline (SCD)?
2. 2.What is the mechanism behind the effects of the Mediterranean diet on physical or/and cognitive function? Is it through vascular protection or improvements in brain structure/brain network function?

Conditions

Subjective Cognitive Decline

Outcome Measures

Primary Outcomes (8)

• Cognitive functional change

  Subjective and objective cognitive functional measurements (MMSE and comprehensive neuropsychological tests for verbal memory, attention, visuospatial function, executive function, and language)

  Three month of allocated diet phase

• Physical function 1 - gait speed change

  Gait speed measurements

  Three month of allocated diet phase

• Physical function 2 - handgrip strength change

  Handgrip strength measurements

  Three month of allocated diet phase

• Physical function 3 - stand from chair speed change

  Five times of stand from chair speed measurements

  Three month of allocated diet phase

• Brain MRI structural change - total and regional voxel-based brain parenchymal features change

  Brain gray matter/white matter volumes and diffusion tensor imaging measurements

  Three month of allocated diet phase

• Brain MRI functional change - total and regional voxel-based brain functional features change

  Resting functional MRI signal analsyes

  Three month of allocated diet phase

• Brain MRI neurovascular lesion change - small vessel disease markers

  white matter hyperintensities, lacune and cerebral microbleeds assessments

  Three month of allocated diet phase

• Brain MRI neurovascular structural change - microvascular density

  arteriolar and venular densities

  Three month of allocated diet phase

Secondary Outcomes (1)

• AD circulatory biomarkers

  Three month of allocated diet phase

Study Arms (2)

Mediterranean diet phase followed by regular diet phase

OTHER

Three-month of M phase, one month of washout and three month of R phase

Other: Mediterranean diet; Other: Regular diet

Regular diet phase followed by Mediterranean diet phase

OTHER

Three-month of R phase followed by three month of M phase

Other: Mediterranean diet; Other: Regular diet

Interventions

Mediterranean diet OTHER

Mediterranean diet for three month

Mediterranean diet phase followed by regular diet phase; Regular diet phase followed by Mediterranean diet phase

Regular diet OTHER

regular diet

Mediterranean diet phase followed by regular diet phase; Regular diet phase followed by Mediterranean diet phase

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjective cognitive decline (SCD)-plus subjects, individuals must meet five criteria:
• Subjective memory decline without impairment in other cognitive domains (MMSE \> 26; MMSE \> 14 for \<6 years of education).
• Onset of subjective cognitive decline within the past 5 years.
• Age at the onset of subjective cognitive decline is \>60 years.
• Concern and preoccupation with memory decline.
• Perceived functional decline relative to peers and meet one of three criteria: a. Caregiver perceives cognitive decline; b. Carries APOE ε4 genotype; c. Clinical evidence of preclinical Alzheimer's disease biomarkers.

You may not qualify if:

• Exclude individuals who:
• Cannot comply with or accept the dietary intervention (e.g., dietary restrictions, vegetarianism, lactose intolerance).
• Have walking speed ≤ 0.3 meters/second.
• Have significant medical conditions affecting physical and cognitive functions.
• Have chronic kidney disease (eGFR \<30 ml/min/1.73m2) or undergo dialysis.
• Experience poorly controlled cardiovascular diseases or malignant tumors.
• Have severe visual and hearing impairments preventing assessments.
• Have undergone hormone therapy in the preceding three months or are expected to during the trial.

Sponsors & Collaborators

• Chih-Ping Chung: lead
• National Yang Ming Chiao Tung University: collaborator

Study Sites (1)

Taipei Veterans General Hospital

Taipei, 11217, Taiwan

Location

MeSH Terms

Interventions

Diet, Mediterranean; Diet

Intervention Hierarchy (Ancestors)

Diet, Plant-Based; Diet Therapy; Nutrition Therapy; Therapeutics; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Chih-Ping Chung, MD PhD

  Department of Neurology, Neurological Institute, Taipei Veterans General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor M.D.

Model Details: Mediterranean diet phase X regular diet phase

Study Record Dates

• First Submitted: February 16, 2024
• First Posted: March 1, 2024
• Study Start: October 26, 2023
• Primary Completion: December 2, 2024
• Study Completion: December 2, 2024
• Last Updated: September 9, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)