Effects of Mediterranean diet on cognitive decline in older adults
Effects of Mediterranean Diet on Physical and Cognitive Functions in Community-dwelling Older People With Subjective Cognitive Decline - a Randomized Controlled Cross-over Trial
This study tests if following a Mediterranean diet for three months can help older adults with early signs of memory problems feel better and think more clearly compared to a regular diet.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 60 Years and up |
| Sex | All |
| Sponsor | Taipei Veterans General Hospital, Taiwan Government |
| Locations | 1 site (Taipei) |
| Trial ID | NCT06287489 on ClinicalTrials.gov |
What this trial studies
This study investigates the impact of a three-month Mediterranean diet on the physical and cognitive functions of older adults experiencing subjective cognitive decline (SCD). It employs a cross-over randomized controlled trial design, comparing the Mediterranean diet to a regular diet. Participants will undergo brain MRI and biomarker assessments to explore the underlying mechanisms of any observed effects. The study aims to determine if the Mediterranean diet can provide more pronounced benefits for those with SCD compared to previous trials focused on cognitively healthy individuals.
Who should consider this trial
Good fit: Ideal candidates are older adults over 60 years old who have experienced subjective memory decline within the past five years without impairment in other cognitive domains.
Not a fit: Patients with significant medical conditions affecting cognitive functions or those unable to comply with dietary interventions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a dietary intervention that significantly improves cognitive and physical functions in older adults with subjective cognitive decline.
How similar studies have performed: Previous studies on the Mediterranean diet have shown positive effects in cognitively healthy individuals, but this approach focusing on those with subjective cognitive decline is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Subjective cognitive decline (SCD)-plus subjects, individuals must meet five criteria: 1. Subjective memory decline without impairment in other cognitive domains (MMSE \> 26; MMSE \> 14 for \<6 years of education). 2. Onset of subjective cognitive decline within the past 5 years. 3. Age at the onset of subjective cognitive decline is \>60 years. 4. Concern and preoccupation with memory decline. 5. 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. Exclusion Criteria: Exclude individuals who: 1. Cannot comply with or accept the dietary intervention (e.g., dietary restrictions, vegetarianism, lactose intolerance). 2. Have walking speed ≤ 0.3 meters/second. 3. Have significant medical conditions affecting physical and cognitive functions. 4. Have chronic kidney disease (eGFR \<30 ml/min/1.73m2) or undergo dialysis. 5. Experience poorly controlled cardiovascular diseases or malignant tumors. 6. Have severe visual and hearing impairments preventing assessments. 7. Have undergone hormone therapy in the preceding three months or are expected to during the trial.
Where this trial is running
Taipei
- Taipei Veterans General Hospital — Taipei, Taiwan (Recruiting)
Study contacts
- Principal investigator: Chih-Ping Chung, MD PhD — Department of Neurology, Neurological Institute, Taipei Veterans General Hospital
- Study coordinator: Chih-Ping Chung, MD PhD
- Email: pin324pin324@gmail.com
- Phone: +886-2-918155976
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.