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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:
Anthropometry data: height, weight, body mass index
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)
Urine test Urine color, appearance, specific gravity, pH, glucose, creatinine
Cognitive function: Montreal cognitive assessment (MoCA), Cognitive abilities screening instruments (CASI)
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Control group were asked to maintain their dietary habit, lifestyle, and used of medication, and were provided 60 mL/packet, twice daily for 24 weeks of fish stock with the same appearance, flavor, and color similar to perch essence as placebo. |
|
| Perch essence | Experimental | Treatment group were asked to maintain their dietary habit, lifestyle, and used of medication, and were provided 60 mL/packet, twice daily for 24 weeks of perch essence. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Perch essence | Dietary Supplement | 60mL/packet of perch essence, twice daily for 24 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | Week 0, 12, and 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Anthropometric data | Weight and height will be combined to calculate BMI (kg/m2) | Week 0, 12, and 24 |
| Blood biochemistry: Nutritional status | Albumin, total protein, Vitamin B12, folate, magnesium |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| School of Nutrition and Health Sciences | Taipei | Xinyi | 110 | Taiwan |
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| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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| Fish stock |
| Dietary Supplement |
60mL/packet of fish stock, twice daily for 24 weeks, with the same appearance, flavor, and color compared to perch essence |
|
| Week 0, 12, and 24 |
| Blood biochemistry: Glycemic profiles | fasting blood glucose | 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) | 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) | Week 0, 12, and 24 |
| Blood biochemistry: BDNF and oxidative stress | Brain derived neurotrophic factor (BDNF), malondialdehyde (MDA) | 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 | Week 0, 24 |