Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06444568
Status:
RECRUITING
Last Update Posted:
2024-06-07
First Post:
2024-05-22
Brief Title:
Modified Ketogenic Diet in Amnestic Mild Cognitive Impairments
Sponsor:
Saglik Bilimleri Universitesi
Organization:
Saglik Bilimleri Universitesi
Study Overview
Official Title:
Efficacy of Modified Ketogenic Diet in Amnestic Mild Cognitive Impairments
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 ie in terms of cognitive function physical and functional measures or metabolicinflammatory 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
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 ie in terms of cognitive function physical and functional measures or metabolicinflammatory 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
Detailed Description:
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 f030 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 ie PC-1 AC-1 or KD-1 passiveactive control and the ketogenic diet respectively It is planned to evaluate cognitive functions with ADAS-Cog Alzheimers 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 gkg per day and 2 a ketogenic diet ratio 11 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-hydroxybutyrateBHB 05-25 mmolL 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 1014
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 ie 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
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 f030 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 ie PC-1 AC-1 or KD-1 passiveactive control and the ketogenic diet respectively It is planned to evaluate cognitive functions with ADAS-Cog Alzheimers 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 gkg per day and 2 a ketogenic diet ratio 11 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-hydroxybutyrateBHB 05-25 mmolL 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 1014
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 ie 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None