Status:
RECRUITING
COGNIFOOD-Changing the Carbohydrate/Fat-ratio to Prevent Cognitive Decline and Alzheimer Pathology: A Pilot Study
Lead Sponsor:
Karolinska University Hospital
Collaborating Sponsors:
Fingers Brain Health Institute
Karolinska Institutet
Conditions:
Prodromal Alzheimer's Disease
Alzheimer Disease
Eligibility:
All Genders
50-85 years
Phase:
NA
Brief Summary
A 2-arm (sequence), 2-period, 2-treatments, single blinded (outcome assessor), randomized crossover-trial (12+12 weeks with immediate contrast) comparing a low-carbohydrate-high-fat diet (LCHF) with a...
Detailed Description
The impact of macronutritional composition on cognitive health is not fully understood. On one hand, the World Health Organization (WHO) guidelines propose a limit of total fat intake at 30% of total ...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
October 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2026
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06105320
Start Date
October 1 2023
End Date
April 1 2026
Last Update
October 27 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Karolinska University Hospital
Solna, Sweden