Actively Recruiting
Modified Ketogenic Diet in Amnestic Mild Cognitive Impairments
Led by Saglik Bilimleri Universitesi · Updated on 2024-11-25
36
Participants Needed
1
Research Sites
40 weeks
Total Duration
On this page
Sponsors
S
Saglik Bilimleri Universitesi
Lead Sponsor
A
Ankara University
Collaborating Sponsor
AI-Summary
What this Trial Is About
This clinical study aims to examine the effectiveness of a 12-week modified ketogenic diet (MKD) intervention, especially on cognitive functions, in individuals diagnosed with amnestic-mild cognitive impairment (aMCI) and to compare the effects of control groups (passive or active). Accordingly, a sample of 36 older adults aged 65-80 years diagnosed with aMCI will be randomized into 3 different groups: passive control (without any intervention), active control (MIND: Mediterranean-DASH Intervention for Neurodegenerative Delay diet) or intervention (MKD). They will be monitored according to targeted criteria throughout the 12-week study protocol. The main questions this study aims to answer are: * Does a 12-week MKD intervention improve cognitive functions in aMCI? * Does the effectiveness of the 12-week MKD intervention in aMCI (i.e., in terms of cognitive function, physical and functional measures, or metabolic/inflammatory biomarkers) differ from control groups? Expected from participants during the study protocol: * Participants assigned to the passive control arm are expected to come to the research center at the beginning (week 0) and end (week 12) of the protocol and participate in evaluations. * Participants assigned to the active control (MIND diet) or intervention (MKD) arm are expected to adhere to assigned dietary therapy, keep a weekly food diary, and have weekly phone calls or online meetings with the dietitian to follow up on the diet. These participants assigned to the diet groups are expected to come to the research center at weeks 0, 4, 8, and 12 to participate in the evaluations.
CONDITIONS
Official Title
Modified Ketogenic Diet in Amnestic Mild Cognitive Impairments
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with amnestic mild cognitive impairment or disorder (aMCI) by a clinician using neuropsychological evaluation and Clinical Dementia Rating Scale of 0.5
- At least 6 years of education
You will not qualify if you...
- Under 65 years or over 80 years old
- Diagnosis of neurological diseases other than MCI or psychological diseases
- Baseline GDS-15 score greater than 5
- Kidney, pancreas, or liver diseases or dysfunctions
- Type 1 diabetes or Type 2 diabetes with insulin therapy
- Cancer or metabolic diseases such as fatty acid oxidation defects
- Thyroid dysfunction, pulmonary or autoimmune diseases
- Head trauma or cardiovascular events like stroke or heart attack in the last year
- Hypercholesterolemia with fasting total cholesterol over 300 mg/dL or LDL cholesterol over 200 mg/dL
- Abnormal vitamin B12 or folate levels in last year
- Nutritional risks including chewing/swallowing difficulties, involuntary weight loss in last 6 months, or BMI under 22 kg/m2
- Use of internal devices or implants such as pacemakers or hearing aids
- Use of anticholinergic, antidementia, or opioid drugs
- Use of antidepressant drugs allowed only if continued for at least 3 months with no changes in type or dose during study
AI-Screening
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Trial Site Locations
Total: 1 location
1
Gulhane Faculty of Medicine & Gulhane Training and Research Hospital
Ankara, Turkey (Türkiye), 06010
Actively Recruiting
Research Team
M
Mehmet I Naharcı, Prof.
CONTACT
H
Hilal Şimşek
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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