To evaluate the effects of a 12-week multi-component nutritional formula on World Health Organization (WHO) Integrated Care for Older People (ICOPE) intrinsic capacity domains, physical function, and metabolic biomarkers in community-dwelling older adults. Besides, the investigators use standardized ICOPE Step 2 assessments, functional capacity scales, and metabolic biomarkers (including GDF-15, HOMA-IR, TyG index, LAP, and FIB-4) as outcome measures to validate whether the multi-component nutritional supplement could improve intrinsic capacity and health in older adults.
With aging, physiological functions and intrinsic capacity across multiple domains decline, leading to increased risks of sarcopenia, frailty, and metabolic dysfunction. The World Health Organization (WHO) introduced the Integrated Care for Older People (ICOPE) framework - covering locomotion, vitality, cognition, psychology, vision, and hearing - to promote healthy aging. This double-blind randomized controlled trial evaluates whether a 12-week intervention using an 18-component multi-component nutritional formula can improve ICOPE intrinsic capacity domains, physical function, and metabolic biomarkers in community-dwelling older adults. Through this trial, investigators aim to establish clinical evidence for nutritional strategies in managing age-related functional and metabolic declines.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Enrollment
70
Daily oral consumption of the multi-component nutritional powder dissolved in warm water for 12 weeks. The formula contains muscle-anabolic proteins (whey protein, yeast protein, leucine), bone-supportive nutrients (MBP, coral calcium, vitamins D3/K2), and bioactive compounds (mulberry leaf extract, astragalus, grape seed extract, phosphatidylserine, fish oil, and lutein).
Daily oral consumption of the matched placebo powder dissolved in warm water for 12 weeks. The placebo is calorie-matched (within 10% caloric difference) but contains no active proteins, free amino acids, calcium/vitamin D3/K2 supplements, fish oil, or botanical extracts.
Kaohsiung Veterans General Hospital
Kaohsiung City, Taiwan
Change in Locomotion Measured by Short Physical Performance Battery (SPPB)
Assessed by the Short Physical Performance Battery (SPPB), covering balance, chair stand, and gait speed. Scores range from 0 to 12, where higher scores indicate better lower-extremity physical function.
Time frame: Baseline, Week 12
Change in 6-Meter Gait Speed
Measured by the 6-meter gait speed test in meters per second (m/s). Higher speed indicates better physical mobility
Time frame: Baseline, Week 12
Change in Handgrip Strength
Measured in kilograms (kg) using a handheld dynamometer on the dominant hand (maximum of two trials). Higher values indicate greater muscle strength.
Time frame: Baseline, Week 12
Change in Nutritional Status by MNA-SF
Assessed by the Mini Nutritional Assessment-Short Form (MNA-SF). Scores range from 0 to 14, where scores ≤11 indicate malnutrition risk and higher scores represent better nutritional status
Time frame: Baseline, Week 12
Change in Body Weight
Measured in kilograms (kg) under fasting conditions.
Time frame: Baseline, Week 12
Change in Calf Circumference
Measured in centimeters (cm) at the widest part of the calf. Higher values indicate greater muscle mass reserve.
Time frame: Baseline, Week 12
Change in Cognitive Function by MoCA
Assessed by the Montreal Cognitive Assessment (MoCA). Scores range from 0 to 30, with higher scores reflecting better global cognitive performance.
Time frame: Baseline, Week 12
Change in Depressive Symptoms by GDS-5
Assessed by the 5-item Geriatric Depression Scale (GDS-5). Scores range from 0 to 5, where higher scores indicate greater depressive symptoms (scores ≥2 suggest depression risk).
Time frame: Baseline, Week 12
Change in Visual Impairment Status
Evaluated based on WHO ICOPE Step 2 vision assessment criteria (classified as visual impairment: Yes or No).
Time frame: Baseline, Week 12
Change in Hearing Impairment Status
Evaluated using the whisper voice test based on WHO ICOPE Step 2 criteria (classified as hearing impairment: Yes or No).
Time frame: Baseline, Week 12
Change in Basic Activities of Daily Living by Barthel Index
Scores range from 0 to 100, where higher scores indicate greater independence in physical functioning and personal care.
Time frame: Baseline, Week 12
Change in Instrumental Activities of Daily Living by Lawton IADL Scale
Assessed using the Lawton Instrumental Activities of Daily Living (IADL) Scale, with scores ranging from 0 to 8, where higher scores indicate better ability to perform instrumental activities of daily living.
Time frame: Baseline, Week 12
Change in Frailty Status by Fried CHS Phenotype
Evaluated using the Fried Cardiovascular Health Study (CHS) criteria (0 to 5 criteria), categorizing participants as robust (0), pre-frail (1-2), or frail (3-5).
Time frame: Baseline, Week 12
Change in Clinical Frailty Scale (CFS)
Measured using the Clinical Frailty Scale (CFS), with scores ranging from 1 to 9, where higher scores indicate greater frailty and a worse outcome.
Time frame: Baseline, Week 12
Change in Quality of Life by SF-36 Health Survey
Assessed by the Short Form 36 (SF-36) questionnaire, evaluating physical and mental health component summary scores (scores 0-100, higher scores reflect better quality of life).
Time frame: Baseline, Week 12
Change in Skeletal Muscle Mass Index by Bioelectrical Impedance Analysis (BIA)
Measured using a multi-frequency InBody Bioelectrical Impedance Analysis (BIA) device. Skeletal Muscle Mass Index (SMI) is expressed in kg/m². Higher SMI values indicate greater skeletal muscle mass relative to height and a better outcome.
Time frame: Baseline, Week 12
Change in Visceral Fat Area by Bioelectrical Impedance Analysis
Measured using a multi-frequency InBody Bioelectrical Impedance Analysis (BIA) device. Visceral Fat Area (VFA) is expressed in cm². Higher VFA values indicate greater visceral adiposity and a worse outcome.
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Time frame: Baseline, Week 12
Change in Body Fat Percentage by Bioelectrical Impedance Analysis
Measured using a multi-frequency InBody Bioelectrical Impedance Analysis (BIA) device. Body Fat Percentage is expressed as a percentage (%). Higher body fat percentage indicates a greater proportion of body fat and a worse outcome.
Time frame: Baseline, Week 12
Change in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)
calculated by Homeostatic Model Assessment for Insulin Resistance, HOMA-IR
Time frame: Baseline, Week 12
Change in Triglyceride-Glucose (TyG) Index
calculated by Triglyceride-Glucose Index, TyG index. Higher values indicate greater metabolic and insulin resistance risk.
Time frame: Baseline, Week 12
Change in Lipid Accumulation Product (LAP)
calculated by Lipid Accumulation Product, LAP. Reflects visceral adiposity.
Time frame: Baseline, Week 12
Change in Serum Growth Differentiation Factor-15 (GDF-15)
measured by serum Growth Differentiation Factor-15, GDF-15, as a circulating biomarker of biological aging and mitochondrial stress.
Time frame: Baseline, Week 12
Change in Fibrosis-4 (FIB-4) Index
calculated by Fibrosis-4 Index, FIB-4. Used to estimate hepatic steatosis-associated fibrosis risk.
Time frame: Baseline, Week 12
Change in Glycated Hemoglobin (HbA1c)
measured by Glycated Hemoglobin, HbA1c
Time frame: Baseline, Week 12
Change in High-Sensitivity C-Reactive Protein (hs-CRP)
Measured in mg/L as a circulating marker of systemic low-grade inflammation.
Time frame: Baseline, Week 12
Change in Serum 25-Hydroxyvitamin D [25(OH)D]
Measured in ng/mL to reflect nutritional vitamin D status
Time frame: Baseline, Week 12