RecruitingNot ApplicableNCT06105320

COGNIFOOD-Changing the Carbohydrate/Fat-ratio to Prevent Cognitive Decline and Alzheimer Pathology: A Pilot Study

COGNIFOOD-Investigating the Therapeutic Potential of Changing the Dietary Carbohydrate/Fat-ratio to Prevent Cognitive Decline and Alzheimer Pathology: A Pilot Study


Sponsor

Karolinska University Hospital

Enrollment

40 participants

Start Date

Oct 1, 2023

Study Type

INTERVENTIONAL

Conditions

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 high-carbohydrate-low-fat diet (HCLF) among individuals with prodromal Alzheimer's disease.


Eligibility

Min Age: 50 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

The COGNIFOOD study is a pilot trial testing whether changing the ratio of carbohydrates to fats in the diet can slow cognitive decline and reduce Alzheimer's-related brain changes in people with very early (prodromal) Alzheimer's disease — meaning they have mild memory and thinking difficulties with biological evidence of Alzheimer's pathology. **You may be eligible if...** - You have been diagnosed with mild cognitive impairment due to Alzheimer's disease, with biological confirmation (via spinal fluid, MRI, or PET scan) - You score 20 or higher on a standard cognitive test (MoCA) - You have a willing and available study partner who can support you and report on your progress - You are motivated to prepare most of your meals according to study guidelines - You can eat plant-based food plus at least one of: fish, meat, or eggs/dairy - You can complete cognitive tests in Swedish **You may NOT be eligible if...** - You have full dementia (not just mild impairment) - You have diabetes, familial hypercholesterolemia, or uncontrolled high blood pressure - Your BMI is below 18 or above 35 - You are currently on metformin, GLP-1 medications, or SGLT-2 inhibitors - You have alcohol or substance use problems Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERLCHF

A diet intervention with the following macronutrient targets: Carbohydrates: 10-25 E%; Fat 50-70 E%; Protein: 20-25 E%; Alcohol 0-5 E%

OTHERHCLF

A diet intervention with the following macronutrient targets: Carbohydrates: 50-60 E%; Fat 25-30 E%; Protein: 15-20 E%; Alcohol 0-5 E%


Locations(1)

Karolinska University Hospital

Solna, Sweden

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NCT06105320


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