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

Taipei Medical University

Status: Completed

Conditions: Mild Cognitive Impairment

Treatments: Dietary Supplement: Fish stock; Dietary Supplement: Perch essence

Study type: Interventional

Funder types: Other

Identifiers

NCT07239635

N202401063

Details and patient eligibility

About

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.

Enrollment: 54 patients

Sex: All

Ages: 45+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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54 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Dietary Supplement: Fish stock

Perch essence

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Perch essence