- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05028920
The Study on Nutritional Status of Patients With Mild Cognitive Impairment
May 22, 2023 updated by: Taipei Medical University
The global aging population is rising year by year.
According to the result of Taiwan epidemiological survey, dementia has become the health issue in aging population.
Mild cognitive function impairment may present years before dementia is diagnosed.
Therefore early diagnosis of dementia at its Mild cognitive function impairment stage is beneficial for disease prevention and potentially delaying the deterioration of cognitive function impairment.
Nutritional status includes a healthy diet, favor body composition and activity habits, which not only reduces the risk of nutritional metabolic diseases, but also has a direct relationship with delaying cognitive function impairment.
The dietary quality index of Mediterranean-Dietary Approaches to Stop Hypertension Intervention for Neurodegenerative Delay diet (MIND diet) may prevent aging and positively associated with delaying dementia in elderly.
However, the result in dietary quality index and delaying cognitive function impairment from current studies were still unclear.
In additions, based on the differences in dietary patterns between Taiwan and Western countries, no current calorie and dietary nutrition recommendations.
This cross-sectional study is to investigate the association between dietary quality index and nutritional status risk factors in cognitive function impairment patients and expected to develop an assessment tool for Taiwanese clinical nutrition strategies and applications.
Study Overview
Status
Enrolling by invitation
Conditions
Detailed Description
Aging populations is rising by years in Taiwan.
Mild cognitive function impairment (MCI) has become the important health issue.
Current knowledge of the etiology of cognitive decline is incomplete, the potential modifiable factors, such as diet may delay the deterioration of disease.
This study is aimed to comprise the differences nutritional status,include dietary nutrients intake, MIND diet scores,body composition analysisin with mild cognitive impairment.
Design and methods: this cross-sectional study from July, 2019.
According to clinical dementia rating (CDR) and mini-mental state examination (MMSE), subjects are divided into healthy group (CDR = 0 and MMSE ≧ 26) and MCI group (CDR ≧ 0.5 and MMSE ≧ 26).
Dietary data were obtained by 3-day dietary records and nutrients intake were calculated by trained dietitian.
We expected to understand the nutritional status of patients with mild cognitive impairment.
Study Type
Observational
Enrollment (Anticipated)
50
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Taipei, Taiwan, 110
- Taipei Medical University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
Study Population
Mild cognitive function impairment (MCI) may present years before dementia is diagnosed.
Therefore early diagnosis of dementia at its MCI stage is beneficial for disease prevention and potentially delaying the deterioration of cognitive function impairment.
Description
Inclusion Criteria:
- Age ≥40 years old (regardless of gender)
- Complete 3-day dietary record, Mini-mental state examination and Clinical dementia rating assessment
- Independent physical activity
Exclusion Criteria:
- No amputation, edema, cancer, terminal case, thyroid disease and stroke include stroke history
- No family support
- Psychological problem
- Extremely data of dietary record(< 500 kcal or > 3500 kcal)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Cross-Sectional
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The dietary quality index: Mediterranean-DASH Intervention for Neurodegenerative Delay diet
Time Frame: at the 12th month
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The MIND score is based on 10 brain-healthy foods groups: namely, higher intake of green leafy vegetables (spinach, lettuce, kale), other vegetables,berries(blueberries,strawberries), nuts, whole grains, fish, beans, poultry, limited intake of wine (red and white wine), and use of olive oil as primary source of fat; and 5 unhealthy foods: namely, lower intakes of butter and margarine, cheese, red meat and products, fast fried foods, and pastries and sweets.For healthy components, assigned 0, 0.5 or 1 point for higher intakes, and for unhealthy components the scoring was reversed (total score 0 to 15 points).
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at the 12th month
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Assessment cognitive function only one time: Mini-mental state examination scale, MMSE
Time Frame: at the 1st month
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Assessment tools of cognitive impairment.Scores: 0 - 30 points.
Among the result of MMSE=23.5±6.6(p<0.05)
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at the 1st month
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Assessment cognitive function only one time:Clinical dementia rating scale, CDR
Time Frame: at the 1st month
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Assessment tools of cognitive impairment.Scores: 0 - 5 points(0 points for normal,0.5 points for mild cognitive impairment, 1 points for mild dementia, 2 points for moderate dementia, 3 points for severe dementia). Among the result of CDR=0.4±0.5(p<0.05) |
at the 1st month
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Lipid profile
Time Frame: at the 1st,12th month
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Serum HDL-Cho, LDL-Cho, triglyceride and total cholesterol are in milligram per deciliter
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at the 1st,12th month
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Kidney function
Time Frame: at the 1st,12th month
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Serum BUN,Creatine and urine acid are in milligram per deciliter
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at the 1st,12th month
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Liver function
Time Frame: at the 1st,12th month
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Serum AST,ALT and bilirubin-total are in units per liter.
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at the 1st,12th month
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 1, 2021
Primary Completion (Anticipated)
December 31, 2023
Study Completion (Anticipated)
June 30, 2024
Study Registration Dates
First Submitted
June 23, 2021
First Submitted That Met QC Criteria
August 30, 2021
First Posted (Actual)
August 31, 2021
Study Record Updates
Last Update Posted (Actual)
May 24, 2023
Last Update Submitted That Met QC Criteria
May 22, 2023
Last Verified
May 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 201900610B0
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Mild Cognitive Impairment
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University of California, San FranciscoNational Institute on Aging (NIA)Active, not recruitingMild Cognitive Impairment | Cognitive Decline | Cognitive Deterioration | Cognitive Impairment, Mild | Cognitive Deficits, MildUnited States
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BaycrestCentre for Aging and Brain Health InnovationUnknownNeurocognitive Disorders | Cognitive Dysfunction | Mental Disorder | Cognitive Impairment, Mild | Cognitive Disorder | Nonamnestic Mild Cognitive ImpairmentCanada
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Mackay Memorial HospitalBened Biomedical Co., Ltd.RecruitingMild Cognitive Impairment (MCI)Taiwan
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Thomas Jefferson UniversityJohns Hopkins University; University of Pennsylvania; National Institute on Aging... and other collaboratorsCompletedMild Cognitive Impairment (MCI)United States
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Palo Alto Veterans Institute for ResearchU.S. Army Medical Research and Development CommandCompletedAmnestic Mild Cognitive ImpairmentUnited States
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Assaf-Harofeh Medical CenterNeurim Pharmaceuticals Ltd.UnknownMild Cognitive Impairment (MCI)Israel
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Xuanwu Hospital, BeijingWuhan University; Beijing Friendship Hospital; First Affiliated Hospital Xi'an... and other collaboratorsRecruitingAmnestic Mild Cognitive ImpairmentChina
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Immunotec Inc.RecruitingMild Cognitive Impairment (MCI)Canada
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Jennifer BramenNational Institutes of Health (NIH); National Institute on Aging (NIA)CompletedAmnestic Mild Cognitive ImpairmentUnited States
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Meir Medical CenterTerminatedMild Cognitive Impairment (MCI)Israel