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Completed

NCT Number: NCT07239635

Effect of Perch Essence on Cognitive Function Status in Subjects With Mild Cognitive Impairment

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.

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Key information

Age range

45 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

School of Nutrition and Health Sciences

Taipei, Xinyi, 110, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • aged ≥ 45
  • diagnosed with mild cognitive impairment by clinical dementia rating (CDR) with a scoring of 0.5
  • have the ability to communicate, reading and writing

Exclusion criteria

  • diagnosed with dementia
  • diagnosed with terminal diseases or severe psychological symptoms (lifespan ≤ 2 years, cancer, severe stroke, heart disease, liver cirrhosis, ESRD, severe depression, etc.)
  • Severe blindness, hearing impairment, or communication disability
  • Branched-chain organic aciduria (e.g., maple syrup urine disease)
  • Individuals who do not consume fish or are allergic to fish products

Treatment and study plan

Perch essence

Dietary Supplement

60mL/packet of perch essence, twice daily for 24 weeks

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

Primary outcomes

  1. Cognitive Abilities Screening Instrument (CASI)

    Time frame: Week 0, 12, and 24

    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.

  2. Montreal Cognitive Assessment

    Time frame: Week 0, 12, and 24

    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.

Secondary outcomes

  1. Anthropometric data

    Time frame: Week 0, 12, and 24

    Weight and height will be combined to calculate BMI (kg/m2)

  2. Blood biochemistry: Nutritional status

    Time frame: Week 0, 12, and 24

    Albumin, total protein, Vitamin B12, folate, magnesium

  3. Blood biochemistry: Glycemic profiles

    Time frame: Week 0, 12, and 24

    fasting blood glucose

  4. Blood biochemistry: Lipid profiles

    Time frame: Week 0, 12, and 24

    total cholesterol (TC), high density lipoprotein cholesterol (HDL-C), low density lipoprotein cholesterol (LDL-C), triglycerides (TG)

  5. Blood biochemistry: Complete blood counts

    Time frame: Week 0, 12, and 24

    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)

  6. Blood biochemistry: BDNF and oxidative stress

    Time frame: Week 0, 12, and 24

    Brain derived neurotrophic factor (BDNF), malondialdehyde (MDA)

  7. Nutrition status

    Time frame: Week 0, 24

    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

Sponsors and collaborators

Lead sponsor

Taipei Medical University

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 20, 2025
Registry last updated
Nov 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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