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

NCT07239635 | Completed

• 1 other identifier: N202401063
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

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. 1.Anthropometry data: height, weight, body mass index
2. 2.Blood biochemistry:
3. 3.Urine test Urine color, appearance, specific gravity, pH, glucose, creatinine
4. 4.Cognitive function: Montreal cognitive assessment (MoCA), Cognitive abilities screening instruments (CASI)
5. 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.

Conditions

Mild Cognitive Impairment

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (7)

• Anthropometric data

  Week 0, 12, and 24

• Blood biochemistry: Nutritional status

  Week 0, 12, and 24

• Blood biochemistry: Glycemic profiles

  Week 0, 12, and 24

• Blood biochemistry: Lipid profiles

  Week 0, 12, and 24

• Blood biochemistry: Complete blood counts

  Week 0, 12, and 24

Study Arms (2)

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.

Dietary Supplement: Fish stock

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.

Dietary Supplement: Perch essence

Interventions

Perch essence DIETARY_SUPPLEMENT

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

Perch essence

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

Placebo

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Taipei Medical University: lead

Study Sites (1)

School of Nutrition and Health Sciences

Taipei, Xinyi, 110, Taiwan

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2025
• First Posted: November 20, 2025
• Study Start: April 16, 2024
• Primary Completion: March 25, 2025
• Study Completion: August 31, 2025
• Last Updated: November 20, 2025

Record last verified: 2024-02

Locations

TW (1)