Modified Ketogenic Diet in Amnestic Mild Cognitive Impairments

Launched by SAGLIK BILIMLERI UNIVERSITESI · May 30, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a modified ketogenic diet (MKD) on cognitive functions in older adults who have been diagnosed with amnestic mild cognitive impairment (aMCI), a condition that affects memory. Over the course of 12 weeks, 36 participants aged 65 to 80 will be divided into three groups: one group will follow the MKD, another will follow a different diet called the MIND diet, and the third group will not change their diet at all. The researchers want to find out if following the MKD can help improve memory and thinking skills compared to the other groups.

To be eligible for this trial, participants must have a diagnosis of aMCI and at least six years of education. They should not have any serious neurological or psychological conditions, and certain health issues, like kidney or liver disease, may exclude them. Those in the diet groups will need to keep a food diary and have regular check-ins with a dietitian, while all participants will have evaluations at the start and end of the study. This research aims to better understand how diet can impact cognitive health in older adults.

Gender

ALL

Eligibility 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.)