Modified Ketogenic Diet in Amnestic Mild Cognitive Impairments
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65-80
SponsorSaglik Bilimleri Universitesi
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Dietary Intervention
Other interventionThe intervention includes the application and follow-up of different diet therapies to individuals (Ketogenic diet and MIND).
Treatment groups
36 Participants
are divided into 3 treatment groupsGroup A: Passive control groupNo intervention 0 interventions
Group B: Active control groupActive comparator 1 intervention
Group C: Intervention group (Modified ketogenic diet)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
ADAS-Cog score
Cognitive functions will be evaluated with the ADAS-Cog (Alzheimer's Disease Assessment Scale: Cognitive Subscale) test. This widely used test to assess global cognition, evaluates memory, language, praxis, and orientation with scores ranging from 0 (minimum) to 70 (maximum); increasing scores indicate poorer cognitive performance.
Time frame
Baseline (week:0) - end of the protocol (week:12)Secondary outcomes
1
Dual-task (Physical performance)
Motor-cognitive dual-task testing will be administered to evaluate physical performance. The determined motor and cognitive tasks are 4 meters walking speed and counting backward from 20, respectively, and time (seconds) will be recorded during these tasks. (baseline and end of the protocol for passive control, all visits for active control or intervention groups).
Time frame
Baseline (week:0) - week:4 - week:8 - end of the protocol (week:12)2
Handgrip strength (kg)
Hand grip strength will be recorded to evaluate physical performance. The measurement will be performed using the Takei T.K.K.5401 Grip-D digital hand dynamometer (Takei Scientific Instruments Co., Ltd, Japan) and will be repeated twice with both hands and the average score (kg) will be recorded. (baseline and end of the protocol for passive control, all visits for active control or intervention groups).
Time frame
Baseline (week:0) - week:4 - week:8 - end of the protocol (week:12)3
Total cholesterol (TC, mg/dL)
Within the scope of the research, the measurement of total cholesterol (TC, mg/dL) was planned to evaluate the effect of dietary intervention on the lipid profile.
Time frame
Baseline (week:0) - end of the protocol (week:12)4
Low-density lipoprotein cholesterol (LDL-C, mg/dL)
Within the scope of the research, the measurement of low-density lipoprotein cholesterol (LDL-C, mg/dL) was planned to evaluate the effect of dietary intervention on the lipid profile.
Time frame
Baseline (week:0) - end of the protocol (week:12)Other outcomes
1
Geriatric Depression Scale-short form (GDS-15) score
GDS-15 scores will be evaluated to assess mood at the baseline and end of the protocol visits. This scale evaluates mood between 0 (minimum) and 15 (maximum) scores; scores of 0-4 are considered normal, 5-8 indicate mild depression; 9-11 indicate moderate depression; and 12-15 indicate severe depression.
Time frame
Baseline (week:0) - end of the protocol (week:12)2
Body weight (kg)
The body weight (kg) will be measured with a Tanita SC330 body composition analyzer (Tanita Health Co., Ltd., Tokyo, Japan) at planned visits throughout the protocol (baseline and end of the protocol for passive control, all visits for active control or intervention groups).
Time frame
Baseline (week:0) - week:4 - week:8 - end of the protocol (week:12)3
Body height (cm)
The height assessment will be performed using a SECA 220 stadiometer (Seca Ltd., United Kingdom) fixed to the wall and recorded in cm.
Time frame
Baseline (week:0)4
Body Mass Index (BMI, kg/m^2)
The body mass index (BMI) will be calculated by dividing the measured body weight (kg) by the square of the height (m). The BMI will be calculated and recorded throughout the protocol (baseline and end of the protocol for passive control, all visits for active control or intervention groups).
Time frame
Baseline (week:0) - week:4 - week:8 - end of the protocol (week:12)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Saglik Bilimleri Universitesi
Lead sponsor
Ankara University
Collaborator
Source ClinicalTrials.gov