Ignite Creation Date:
2024-05-06 @ 8:11 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06287489
Status:
RECRUITING
Last Update Posted:
2024-03-01
First Post:
2024-02-16
Brief Title:
Effects of Mediterranean Diet on Subjective Cognitive Decline
Sponsor:
Chih-Ping Chung
Organization:
Taipei Veterans General Hospital Taiwan
Study Overview
Official Title:
Effects of Mediterranean Diet on Physical and Cognitive Functions in Community-dwelling Older People With Subjective Cognitive Decline - a Randomized Controlled Cross-over Trial
Status:
RECRUITING
Status Verified Date:
2024-02
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:
Research Questions
1 Due to the fact that most participants in past clinical trials on the Mediterranean diet were cognitively healthy individuals and while the observed effects were significant they were not particularly substantial does the Mediterranean diet have similarly significant and more pronounced effects on both physical and cognitive functions in older adults with subjective cognitive decline SCD
2 What is the mechanism behind the effects of the Mediterranean diet on physical orand cognitive function Is it through vascular protection or improvements in brain structurebrain network function
Research Objective
Conduct a cross-over randomized controlled trial to investigate the effects of a three-month Mediterranean diet on the physical and cognitive functions of older adults with subjective cognitive decline SCD in the community Utilize brain MRI and circulatory biomarkers measurements to elucidate the underlying mechanisms
1 Due to the fact that most participants in past clinical trials on the Mediterranean diet were cognitively healthy individuals and while the observed effects were significant they were not particularly substantial does the Mediterranean diet have similarly significant and more pronounced effects on both physical and cognitive functions in older adults with subjective cognitive decline SCD
2 What is the mechanism behind the effects of the Mediterranean diet on physical orand cognitive function Is it through vascular protection or improvements in brain structurebrain network function
Research Objective
Conduct a cross-over randomized controlled trial to investigate the effects of a three-month Mediterranean diet on the physical and cognitive functions of older adults with subjective cognitive decline SCD in the community Utilize brain MRI and circulatory biomarkers measurements to elucidate the underlying mechanisms
Detailed Description:
Research Questions
1 Due to the fact that most participants in past clinical trials on the Mediterranean diet were cognitively healthy individuals and while the observed effects were significant they were not particularly substantial does the Mediterranean diet have similarly significant and more pronounced effects on both physical and cognitive functions in older adults with subjective cognitive decline SCD
2 What is the mechanism behind the effects of the Mediterranean diet on physical orand cognitive function Is it through vascular protection or improvements in brain structurebrain network function
Research Objective
Conduct a randomized controlled trial to investigate the effects of a three-month Mediterranean diet on the physical and cognitive functions of older adults with subjective cognitive decline SCD in the community Utilize brain MRI to elucidate the underlying mechanisms
Participants inclusion criteria
SCD-plus subjects must fullfill the following five criteria
1 Subjective memory decline without impairment in other cognitive domains MMSE 26 MMSE 14 for those with less than six years of education
2 Onset of subjective cognitive decline within the past 5 years
3 Age at the onset of subjective cognitive decline is greater than 60 years
4 Concern and preoccupation with the decline in memory
5 Perceived functional decline relative to peers and meet one of the following three criteria
1 Caregiver perceives cognitive decline
2 Carries the APOE ε4 genotype
3 Clinical evidence of preclinical Alzheimers disease biomarkers
Participants exclusion criteria
1 Cases unable to comply with or accept the dietary intervention including individuals with dietary restrictions such as vegetarianism lactose intolerance or potential food allergies
2 Walking speed 03 meterssecond
3 Any significant medical conditions affecting physical and cognitive functions including
1 Limb fracture within the past six months
2 Severe arthritis within the past six months
3 Neurological and psychiatric disorders as determined by the principal investigator eg stroke Parkinsons disease peripheral neuropathy mental disorders
4 Intermittent claudication due to peripheral arterial disease
4 Chronic kidney disease eGFR 30 mlmin173m2 and individuals undergoing dialysis
5 Poorly controlled cardiovascular diseases as determined by the principal investigator
6 Poorly controlled malignant tumors as determined by the principal investigator
7 Severe visual and hearing impairments preventing the completion of assessments and tests
8 Participants who have undergone hormone therapy in the three months preceding the trial or are expected to undergo hormone therapy during the trial
Study Design or Implementation
This study is a cross-over three month of Mediterranean diet phase M and three month of regular diet phase R randomized controlled trial with a duration of six to seven months seven month for MR group with an additional one-month washout period During the study period participants in the M phase will receive a daily portion of a Mediterranean diet designed by a nutritionist Regular Mediterranean diet education and reviews will be conducted to ensure that the Mediterranean Diet Score System MDSS reaches a score of 10 The R phase will follow a self-selected diet and the MDSS during then will also be assessed
Eligible participants will be randomly assigned to two groups with different diet sequences MR or RM group in a 11 ratio T0 measurements will be conducted including a basic information questionnaire blood biomarker sampling for Alzheimers disease and the initial assessment of physical and cognitive functions Dietary assessments and education will be conducted before entering the dietary intervention group and at one week two weeks one month two months and three months after entering each phase Other measurements including blood pressure heart rate height and weight measurements blood tests and brain MRI will be performed at T1 and T2 end of each diet phase
1 Due to the fact that most participants in past clinical trials on the Mediterranean diet were cognitively healthy individuals and while the observed effects were significant they were not particularly substantial does the Mediterranean diet have similarly significant and more pronounced effects on both physical and cognitive functions in older adults with subjective cognitive decline SCD
2 What is the mechanism behind the effects of the Mediterranean diet on physical orand cognitive function Is it through vascular protection or improvements in brain structurebrain network function
Research Objective
Conduct a randomized controlled trial to investigate the effects of a three-month Mediterranean diet on the physical and cognitive functions of older adults with subjective cognitive decline SCD in the community Utilize brain MRI to elucidate the underlying mechanisms
Participants inclusion criteria
SCD-plus subjects must fullfill the following five criteria
1 Subjective memory decline without impairment in other cognitive domains MMSE 26 MMSE 14 for those with less than six years of education
2 Onset of subjective cognitive decline within the past 5 years
3 Age at the onset of subjective cognitive decline is greater than 60 years
4 Concern and preoccupation with the decline in memory
5 Perceived functional decline relative to peers and meet one of the following three criteria
1 Caregiver perceives cognitive decline
2 Carries the APOE ε4 genotype
3 Clinical evidence of preclinical Alzheimers disease biomarkers
Participants exclusion criteria
1 Cases unable to comply with or accept the dietary intervention including individuals with dietary restrictions such as vegetarianism lactose intolerance or potential food allergies
2 Walking speed 03 meterssecond
3 Any significant medical conditions affecting physical and cognitive functions including
1 Limb fracture within the past six months
2 Severe arthritis within the past six months
3 Neurological and psychiatric disorders as determined by the principal investigator eg stroke Parkinsons disease peripheral neuropathy mental disorders
4 Intermittent claudication due to peripheral arterial disease
4 Chronic kidney disease eGFR 30 mlmin173m2 and individuals undergoing dialysis
5 Poorly controlled cardiovascular diseases as determined by the principal investigator
6 Poorly controlled malignant tumors as determined by the principal investigator
7 Severe visual and hearing impairments preventing the completion of assessments and tests
8 Participants who have undergone hormone therapy in the three months preceding the trial or are expected to undergo hormone therapy during the trial
Study Design or Implementation
This study is a cross-over three month of Mediterranean diet phase M and three month of regular diet phase R randomized controlled trial with a duration of six to seven months seven month for MR group with an additional one-month washout period During the study period participants in the M phase will receive a daily portion of a Mediterranean diet designed by a nutritionist Regular Mediterranean diet education and reviews will be conducted to ensure that the Mediterranean Diet Score System MDSS reaches a score of 10 The R phase will follow a self-selected diet and the MDSS during then will also be assessed
Eligible participants will be randomly assigned to two groups with different diet sequences MR or RM group in a 11 ratio T0 measurements will be conducted including a basic information questionnaire blood biomarker sampling for Alzheimers disease and the initial assessment of physical and cognitive functions Dietary assessments and education will be conducted before entering the dietary intervention group and at one week two weeks one month two months and three months after entering each phase Other measurements including blood pressure heart rate height and weight measurements blood tests and brain MRI will be performed at T1 and T2 end of each diet phase
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