Modified ketogenic diet for improving cognitive function in older adults with mild cognitive impairment
Efficacy of Modified Ketogenic Diet in Amnestic Mild Cognitive Impairments
This study is testing if a special modified ketogenic diet can help older adults with mild cognitive impairment improve their thinking skills over 12 weeks.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (estimated) |
| Ages | 65 Years to 80 Years |
| Sex | All |
| Sponsor | Saglik Bilimleri Universitesi Academic / other |
| Locations | 1 site (Ankara) |
| Trial ID | NCT06444568 on ClinicalTrials.gov |
What this trial studies
This clinical study investigates the effectiveness of a 12-week modified ketogenic diet (MKD) on cognitive functions in older adults diagnosed with amnestic mild cognitive impairment (aMCI). A total of 36 participants aged 65-80 will be randomly assigned to one of three groups: a passive control group, an active control group following the MIND diet, or the MKD intervention group. The study aims to assess improvements in cognitive function, physical performance, and metabolic/inflammatory biomarkers compared to the control groups. Participants will be monitored throughout the study to evaluate the impact of the dietary intervention.
Who should consider this trial
Good fit: Ideal candidates are older adults aged 65-80 diagnosed with amnestic mild cognitive impairment.
Not a fit: Patients with other neurological or psychological disorders, significant comorbidities, or those outside the age range may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could enhance cognitive functions in older adults with mild cognitive impairment, potentially slowing disease progression.
How similar studies have performed: Other studies have shown promising results with ketogenic diets in cognitive function, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Having been diagnosed with "amnestic mild cognitive impairment/disorder (aMCI)" by the clinician after the evaluation of cognitive functions according to the neuropsychological evaluation method (0.5 according to the Clinical Dementia Rating Scale (CDR).) * Having at least 6 years of education. Exclusion Criteria: * Under the age of 65 or over the age of 80. * Diagnosis of neurological (other than MCI) or psychological diseases. * GDS-15 score \> 5 (baseline) * Kidney/pancreas/liver diseases or dysfunctions, Type 1 diabetes (and Type II diabetic patients receiving insulin replacement therapy), cancer, metabolic diseases (fatty acid oxidation defect, etc.), thyroid dysfunction, pulmonary or autoimmune diseases, head trauma, history of any cardiovascular event (i.e., stroke, myocardial infarction) in the last year. * Hypercholesterolemia (fasting T-C \>300 mg/dL or LDL-C \>200 mg/dL), non-reference B12 or folate levels according to biochemical tests performed in the last year. * Nutritional risks (chewing/swallowing difficulties, history of involuntary weight loss in the last 6 months, body mass index \< 22 kg/m2). * Use of internal device/implant (pacemaker or hearing aid, etc.). * Medication use (individuals using anticholinergic, antidementia, and opioid class drugs will be excluded; individuals using antidepressant class drugs will be included in the study on the condition that it has been continued for at least 3 months and there is no change in drug type and dose during the study protocol.)
Where this trial is running
Ankara
- Gulhane Faculty of Medicine & Gulhane Training and Research Hospital — Ankara, Turkey (Türkiye) (Recruiting)
Study contacts
- Study coordinator: Mehmet I Naharcı, Prof.
- Email: drnaharci@yahoo.com
- Phone: (+90)3123812350/6578
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.