With global population aging, cognitive impairment and dementia have become major public health issues worldwide. According to the 2019 World Alzheimer Report by the Alzheimer's Disease International, there are more than 50 million people living with dementia globally, and this number is projected to rise to 152 million by 2050, with one new case occurring every three seconds. Our research is to investigate the intervention effects of perch essence on cognitive function in mild-cognitive impairment patients. 1\. Study population: 54 MCI patients were recruited and the inclusion criteria are: (1) aged ≥ 45, (2) diagnosed with mild cognitive impairment by clinical dementia rating (CDR) with a scoring of 0.5, and (3) have the ability to communicate, reading and writing. The exclusion criteria are: (1) diagnosed with dementia, (2) diagnosed with terminal diseases or severe psychological symptoms (lifespan ≤ 2 years, cancer, severe stroke, heart disease, liver cirrhosis, ESRD, severe depression, etc.), (3) Severe blindness, hearing impairment, or communication disability, (4) Branched-chain organic aciduria (e.g., maple syrup urine disease), (5) Individuals who do not consume fish or are allergic to fish products 2. Study design: A two-arm single-blind randomized controlled clinical trial will be performed for 24 weeks and the subjects will be divided in to 2 groups: (1) control group, (2) treatment group. S The treatment group were asked to consume 60mL/packet of perch essence, twice daily for 24 weeks, whereas the control group were provided with the same appearance, flavor, and color of fish stock. Participants were asked to maintain their dietary habit, lifestyle, and used of medication. 3\. Outcome assessment: 1. Anthropometry data: height, weight, body mass index 2. Blood biochemistry: A. Nutritional status: albumin, total protein, Vitamin B12, folate, magnesium B. Glycemic profiles: fasting blood glucose C. Lipid profiles: total cholesterol (TC), high density lipoprotein cholesterol (HDL-C), low density lipoprotein cholesterol (LDL-C), triglycerides (TG). D. Complete blood counts: white blood cells (WBC), red blood cells (RBC), hemoglobin (HB), platelet count (PLT), hematocrit (HCT), mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC). E. Brain derived neurotrophic factor (BDNF), malondialdehyde (MDA) 3. Urine test Urine color, appearance, specific gravity, pH, glucose, creatinine 4. Cognitive function: Montreal cognitive assessment (MoCA), Cognitive abilities screening instruments (CASI) 5. Nutrition status Mini-nutritional assessments (MNA), 3-day dietary recall The purpose of the study investigated the intervention of perch essence supplement on cognitive function and its correlation with nutritional status in MCI patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
54
60mL/packet of perch essence, twice daily for 24 weeks
60mL/packet of fish stock, twice daily for 24 weeks, with the same appearance, flavor, and color compared to perch essence
School of Nutrition and Health Sciences
Taipei, Xinyi, Taiwan
Cognitive Abilities Screening Instrument (CASI)
Cognitive assessments, ranges from 0 to 100, with higher scores indicating better cognitive function, lower than 74 may indicate cognitive impairment, and scores are also affected by age and education level.
Time frame: Week 0, 12, and 24
Montreal Cognitive Assessment
Cognitive assessments, 30 score as full, scoring ≥26 considered as normal, below 26 may indicate impairment, with a score of 18-25 suggesting mild impairment, 10-17 moderate impairment, and below 10 indicating severe impairment.
Time frame: Week 0, 12, and 24
Anthropometric data
Weight and height will be combined to calculate BMI (kg/m2)
Time frame: Week 0, 12, and 24
Blood biochemistry: Nutritional status
Albumin, total protein, Vitamin B12, folate, magnesium
Time frame: Week 0, 12, and 24
Blood biochemistry: Glycemic profiles
fasting blood glucose
Time frame: Week 0, 12, and 24
Blood biochemistry: Lipid profiles
total cholesterol (TC), high density lipoprotein cholesterol (HDL-C), low density lipoprotein cholesterol (LDL-C), triglycerides (TG)
Time frame: Week 0, 12, and 24
Blood biochemistry: Complete blood counts
white blood cells (WBC), red blood cells (RBC), hemoglobin (HB), platelet count (PLT), hematocrit (HCT), mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC)
Time frame: Week 0, 12, and 24
Blood biochemistry: BDNF and oxidative stress
Brain derived neurotrophic factor (BDNF), malondialdehyde (MDA)
Time frame: Week 0, 12, and 24
Nutrition status
Mini-nutritional assessments (MNA): Maximum scores are at 30; scores ≥ 24: not in malnutrition risk; 17-23.5: risk in malnutrition, \<17: malnutrition. 3-day dietary recall
Time frame: Week 0, 24
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