An interventional study of Dietary Intervention in Amnestic Mild Cognitive Disorder and Amnestic Mild Cognitive Impairment, sponsored by Saglik Bilimleri Universitesi. Recruiting at 1 site in Turkey. Open to participants aged 65 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-11-25.
Sponsored by Saglik Bilimleri Universitesi · Not applicable, Interventional, and Treatment
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:
Expected from participants during the study protocol:
This study is an open-label, parallel-group randomized controlled clinical trial. The researchers hypothesized that a 12-week modified ketogenic diet (MKD) intervention in participants diagnosed with amnestic-mild cognitive impairments (aMCI) would improve cognitive functions and progression criteria compared to control groups.
The research sample will consist of individuals diagnosed with aMCI, and 36 volunteers, 12 individuals, were randomly assigned to three different research arms according to the block randomization method. To evaluate this sample size in the "repeated measures ANOVA" test of three independent groups with a medium effect size (f:0.30), 5% significance level (α), and 90% power (1-β) in the power analysis, the sample size should be at least 27 individuals has been calculated.
According to the dropout rate (25%) reported in similar ketogenic diet intervention studies in the literature, 36 was targeted as the sample size of the study.
For confidentiality purposes, the coding method will be used in the processing of data according to the study arms and the order of inclusion in the protocol (i.e., PC-1, AC-1, or KD-1, passive/active control, and the ketogenic diet, respectively). It is planned to evaluate cognitive functions with ADAS-Cog (Alzheimer's Disease Assessment Scale: Cognitive Subscale), physical performance with motor-cognitive dual-task and hand grip strength, and functional capacity with Lawton instrumental activities of daily living scale. Yesavage Geriatric Depression Scale-short form (GDS-15), which will also be used as an eligibility criterion, will be used to evaluate mood.
Intervention: After examining the food consumption diaries (7 days), diet planning will be made for the appropriate study arm (MIND or MKD). The daily energy of the diets is eucaloric in two diet groups, and daily energy will be determined according to the daily average energy intake determined by the nutritional status assessment of the individual and the ESPEN (European Society for Clinical Nutrition and Metabolism) consensus recommendation.
Ketogenic diet calculations will be made through the KetoDietCalculator program. The two basic principles of the planned modified ketogenic diet are 1) protein intake of 1 g/kg per day, and 2) a ketogenic diet ratio 1:1. According to the determined daily energy intake, the contribution of macronutrients to daily energy will be determined by the ketogenic diet ratio. Controlling protein intake per body weight is not a routine practice in ketogenic diet applications, and in this study - to preserve lean body mass as much as possible in elderly individuals - the ESPEN consensus recommendation will be taken into account in the calculations.
The MIND diet, which is the control group diet, will be planned following the 14 dietary guidelines defined elsewhere, and the above criteria will be applied in the same way in determining daily energy. MIND is a diet whose neuroprotective properties are currently accepted, with its ability to delay cognitive function loss and dementia supported by many population-based prospective studies.
Following the dietary training, both groups will be given brochures containing the basic principles and instructions of the diet and educational materials containing recipes developed specifically for the diet group. Compliance with the ketogenic diet is evaluated according to the individuals' serum ketone level (compliance criterion: β-hydroxybutyrate/BHB: 0.5-2.5 mmol/L) and food consumption diaries evaluated at 4, 8, and 12 weeks. Compliance with the MIND diet, which is the active control diet, will be evaluated with the MIND diet score calculated from weekly food consumption diaries (compliance criterion: MIND score >10/14).
In evaluating all outcome variables, the per-protocol analysis method will be applied to examine only participants who completed the research protocol. The intention-to-treat method will be used to evaluate some secondary outcome variables (i.e., biomarkers and anthropometry). Changes in primary and secondary outcome variables between the intervention and control groups during the study will be evaluated by repeated measures ANOVA test. All statistical tests will be evaluated in the SPSS (Statistical Package for Social Science) program at 90% power and 5% significance level.
3,843 studies on the registry are indexed under Cognitive Dysfunction; 1,100 are open to participants now.
This study's planned enrollment of 36 is below the median of 65 across 2,808 interventional studies indexed under Cognitive Dysfunction.
Browse Cognitive Dysfunction studies →Saglik Bilimleri Universitesi is the lead sponsor of 430 studies on the registry; 137 are open to participants now.
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Exclusion Criteria:
The passive control arm will not receive any intervention and will only be evaluated for primary outcome variables at the beginning (week: 0) and at the end (week: 12) of the protocol.
MIND diet will be applied to participants assigned to the active control arm for 12 weeks. This group will be evaluated at visits (week: 0-4-8-12) in terms of primary and secondary outcome variables, in parallel with the intervention group (KD).
Other: Dietary Intervention
The modified ketogenic diet (MKD) will be applied to participants assigned to the intervention arm for 12 weeks. This group will be evaluated for primary and secondary outcome variables at visits (weeks 0-4-8-12).
Other: Dietary Intervention
The intervention includes the application and follow-up of different diet therapies to individuals (Ketogenic diet and MIND).
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)
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)
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)
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)
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)
High-density lipoprotein cholesterol (HDL-C, mg/dL)
Within the scope of the research, the measurement of high-density lipoprotein cholesterol (HDL-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)
Tumor Necrosis Factor-alpha (TNF-α, pg/mL)
Within the scope of the research, the measurement of Tumor Necrosis Factor-α (TNF-α) was planned to evaluate the effect of dietary intervention on the inflammatory response.
Time frame: Baseline (week:0) - end of the protocol (week:12)
β-hydroxybutyrate (β-HB, mmol/L)
Within the scope of the research, serum β-HB was planned at all the visits to monitor compliance with the ketogenic diet. (compliance criteria: β-HB: 0,5-2,5 mmol/L).
Time frame: Baseline (week:0) - week:4 - week:8 - end of the protocol (week:12)
Serum malondialdehyde (MDA) (nmol/mL)
Within the scope of the research, the measurement of serum malondialdehyde (MDA) was planned to evaluate the effect of dietary intervention on lipid peroxidation.
Time frame: Baseline (week:0) - end of the protocol (week:12)
Serum Glutathione peroxidase (GSH-Px, U/mL)
Within the scope of the research, the measurement of serum Glutathione Peroxidase (GSH-Px) activity was planned to evaluate the effect of dietary intervention on oxidative state.
Time frame: Baseline (week:0) - end of the protocol (week:12)
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)
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)
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)
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)
Fat-free mass (kg, via body composition analysis)
Body composition will be analyzed via bioelectrical impedance analysis (BIA) using a Tanita SC330 body composition analyzer (Tanita Health Co., Ltd., Tokyo, Japan). The fat-free mass (kg) obtained as a result of this analysis will be recorded to examine the effects of the intervention at visits planned throughout the protocol. (baseline and end of 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)
Fat mass (kg, via body composition analysis)
Body composition will be analyzed via bioelectrical impedance analysis (BIA) using a Tanita SC330 body composition analyzer (Tanita Health Co., Ltd., Tokyo, Japan). The fat mass (kg) obtained as a result of this analysis will be recorded to examine the effects of the intervention at visits planned throughout the protocol. (baseline and end of 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)
Weekly reported side effects relevant ketogenic diet
Reported side effects will be recorded weekly only in the MKD arm to monitor compliance and tolerance to the ketogenic diet.
Time frame: week 0-12
Plan to share: No
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Saglik Bilimleri Universitesi