The Study on Nutritional Status of Patients With Mild Cognitive Impairment

NCT05028920 | Unknown

• 1 other identifier: 201900610B0
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Mild Cognitive Impairment

Outcome Measures

Primary Outcomes (3)

• 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).

  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)

  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)

  at the 1st month

Secondary Outcomes (3)

• Lipid profile

  at the 1st,12th month

• Kidney function

  at the 1st,12th month

• Liver function

  at the 1st,12th month

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Age ≥40 years old (regardless of gender)
• Complete 3-day dietary record, Mini-mental state examination and Clinical dementia rating assessment
• Independent physical activity

You may not qualify if:

• 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)

Sponsors & Collaborators

• Taipei Medical University: lead

Study Sites (1)

Taipei Medical University

Taipei, 110, Taiwan

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2021
• First Posted: August 31, 2021
• Study Start: July 1, 2021
• Primary Completion: December 31, 2023
• Study Completion: June 30, 2024
• Last Updated: May 24, 2023

Record last verified: 2023-05

Locations

TW (1)