Mild Cognitive ImpairmentNCT05028920
The Study on Nutritional Status of Patients With Mild Cognitive Impairment
An observational study of Mild Cognitive Impairment, run by Taipei Medical University at 1 site in Taiwan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Mild Cognitive Impairment
- How many people
- 50 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jul 2021to 30 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Age ≥40 years old (regardless of gender)
- Complete 3-day dietary record, Mini-mental state examination and Clinical dementia rating assessment
- Independent physical activity
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Mild Cognitive Impairment
- Medical subject headings
- Cognitive Dysfunction
What is being measured
The primary outcome is the main question the study is designed to answer.
The dietary quality index: Mediterranean-DASH Intervention for Neurodegenerative Delay diet
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).
Measured: at the 12th month
Assessment cognitive function only one time: Mini-mental state examination scale, MMSE
Assessment tools of cognitive impairment.Scores: 0 - 30 points. Among the result of MMSE=23.5±6.6(p<0.05)
Measured: at the 1st month
Assessment cognitive function only one time:Clinical dementia rating scale, CDR
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)
Measured: at the 1st month
Secondary outcomes (3)
Lipid profile
Serum HDL-Cho, LDL-Cho, triglyceride and total cholesterol are in milligram per deciliter
Measured: at the 1st,12th month
Kidney function
Serum BUN,Creatine and urine acid are in milligram per deciliter
Measured: at the 1st,12th month
Liver function
Serum AST,ALT and bilirubin-total are in units per liter.
Measured: at the 1st,12th month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2021
- Study start1 Jul 2021
- Primary completion31 Dec 2023 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by Taipei Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05028920
- Sponsor's protocol ID
- 201900610B0
- Status last verified
- May 2023
- First submitted
- 23 Jun 2021
- Last updated
- 24 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Study on Nutritional Status of Patients With Mild Cognitive Impairment
- ClinicalTrials.gov ID
- NCT05028920
- Acronym / sponsor ID
- 201900610B0
- Conditions
- Mild Cognitive Impairment
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Taipei Medical UniversityUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 31 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Age ≥40 years old (regardless of gender)
- Complete 3-day dietary record, Mini-mental state examination and Clinical dementia rating assessment
- Independent physical activity
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The dietary quality index: Mediterranean-DASH Intervention for Neurodegenerative Delay diet
Time frame: at the 12th month
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).
Assessment cognitive function only one time: Mini-mental state examination scale, MMSE
Time frame: at the 1st month
Assessment tools of cognitive impairment.Scores: 0 - 30 points. Among the result of MMSE=23.5±6.6(p<0.05)
Assessment cognitive function only one time:Clinical dementia rating scale, CDR
Time frame: at the 1st month
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)
3 secondary outcomes
Lipid profile
Time frame: at the 1st,12th month
Kidney function
Time frame: at the 1st,12th month
Liver function
Time frame: at the 1st,12th month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mild Cognitive Impairment, run by Taipei Medical University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The dietary quality index: Mediterranean-DASH Intervention for Neurodegenerative Delay diet (time frame: at the 12th month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2023.