Changing carbohydrate and fat ratios to prevent cognitive decline
COGNIFOOD-Investigating the Therapeutic Potential of Changing the Dietary Carbohydrate/Fat-ratio to Prevent Cognitive Decline and Alzheimer Pathology: A Pilot Study
This study tests whether changing the balance of carbohydrates and fats in the diet can help people with early signs of Alzheimer's disease keep their thinking skills sharper.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 50 Years to 85 Years |
| Sex | All |
| Sponsor | Karolinska University Hospital Academic / other |
| Locations | 1 site (Solna) |
| Trial ID | NCT06105320 on ClinicalTrials.gov |
What this trial studies
This pilot study investigates the effects of two different dietary approaches on cognitive health in individuals with prodromal Alzheimer's disease. Participants will undergo a randomized crossover design, alternating between a low-carbohydrate-high-fat diet and a high-carbohydrate-low-fat diet over 12-week periods. The study aims to evaluate how changes in macronutritional composition may influence cognitive function and Alzheimer pathology. By comparing these two dietary regimens, the research seeks to identify potential dietary strategies for preventing cognitive decline.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals diagnosed with prodromal Alzheimer's disease, characterized by mild cognitive impairment and evidence of Alzheimer pathology.
Not a fit: Patients with advanced Alzheimer's disease or those without any evidence of Alzheimer pathology will likely not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into dietary interventions that may help prevent or slow cognitive decline in individuals at risk for Alzheimer's disease.
How similar studies have performed: While some pilot studies on ketogenic diets have shown promising results, the specific approach of liberal carbohydrate restriction in this context is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Ability to fully understand written and verbal information regarding the study and provide signed and dated informed consent * Prodromal Alzheimer's disease, as defined by Mild Neurocognitive Disorder due to Alzheimer's disease (AD) according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria, and evidence for underlying AD pathology by either: * Cerebrospinal fluid (CSF) β-amyloid 1-42/1-40x10 ratio \< 1 and/or total tau and/or phospho-tau and/or β-amyloid 42 based on local cut-offs OR * Magnetic Resonance Imaging (MRI) evidence for medial temporal lobe atrophy (MTA score 1 or higher \[mesiotemporal atrophy\]) OR * Abnormal Fludeoxyglucose F18 (FDG) Positron Imaging Tomography (PET) and/or Pittsburgh Compound-B (PiB) PET compatible with AD type changes. (When the diagnosis prodromal AD is confirmed from medical record, no cognitive testing or renewed assessment of biological AD-pathology is needed for fulfilling this criterion.) * Montreal Cognitive Assessment (MoCa) ≥20. * Availability of a study partner with sufficient contact with the participant, willing and able to give follow-up information on the participant as well as supporting the participant throughout the study. * Self-reported expected motivation and ability to prepare most weakly meals according to given instructions, with support from the study partner. * Accept plant-based food, plus food from at least one of the following categories: A. Fish; B. Meat; C. Eggs and dairy * Ability to reliably undergo a cognitive test in Swedish Exclusion Criteria: * Major Neurocognitive Disorder (dementia) according to DSM-5 * Body-mass Index (BMI) \< 18 or BMI \> 35 * Diagnosed Diabetes Mellitus. * Ongoing treatment with Metformin, Glucagon-Like Peptide 1 (GLP-1)-analog, or Sodium-Glucose Transport Protein 2 (SGLT-2)-inhibitors * Diagnosed Familial Hypercholesterolemia * Untreated or unstable Hypertension * Alcohol or Substance abuse (current or within 2 years) * A concomitant serious disease (e.g., cancer, or major psychiatric disorder or other neurological disorder than AD) as judged by study physician * Major depression or Suicidal ideations (current or within 2 years) * History of Stroke or Myocardial infarction during the last 5 years. * Subjects with brain MRI (or CT) scan clinically significant infarct, intracranial macro bleeding, mass lesion or Normal Pressure Hydrocephalus. Those subjects with an MRI scan demonstrating minimal white matter changes (Fazekas scale for white matter lesions classification of 2 or below) and up to 2 lacunar infarcts which are judged to be clinically insignificant are allowed. * Severe loss of vision or communicative ability * Conditions preventing cooperation as judged by the study physician. * Participation in any other intervention trial within 30 days (or, if applicable, 5 half-lives of the relevant drug if longer) before baseline and along the study period. * Any planned changes in cognitive enhancers (e.g., ginkgo, cholinesterase inhibitors), statins, antidepressants, sleeping pills, supplements like medium-chain triglycerides, or any medication expected to influence cognitive function. Such medications are accepted if taken on a stable dose ≥3 months prior to baseline assessment and should, if possible, remain on the same dose during the study. Unplanned changes that take place within the study do not imply exclusion but should be registered in the case report form (CRF). * Deviations from habitual diet within 1 month before study start. A carbohydrate-restricted or fat-restricted diet, as well as any time-restricted eating, is accepted as habitual diet if stable (and the participant is open to change).
Where this trial is running
Solna
- Karolinska University Hospital — Solna, Sweden (Recruiting)
Study contacts
- Principal investigator: Anne Börjesson-Hanson, MD, PhD — Karolinska University Hospital
- Study coordinator: Anne Börjesson-Hanson, MD, PhD
- Email: anne.borjesson-hanson@regionstockholm.se
- Phone: +46-8-123 858 68
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.