Intrinsic Capacity, Sarcopenia
Conditions
Keywords
Sarcopenia, frailty, intrinsic capacity, Physical Function, Metabolic Biomarkers, Multi-Component Nutritional Supplement
Brief summary
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.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTMulti-Component Nutritional Formula
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).
DIETARY_SUPPLEMENTmatched placebo
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.
Sponsors
National Yang Ming Chiao Tung University
Kaohsiung Veterans General Hospital.
Taiwan Association of Integrated Care
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Intervention model description
Seventy community-dwelling or outpatient older adults (≥65 years, with ≥1 ICOPE domain impairment) will be randomized 1:1 to Nutritional Supplement A or matched placebo for 12 weeks. ICOPE Step 2 standardized assessment covers all six domains. Layer 2 outcomes include IADL (Lawton), Barthel Index, CHS Frailty Phenotype, CFS, SF-36, and body composition (InBody BIA + DXA). Layer 3 metabolic biomarkers are assessed at baseline and Week 12.
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age 65 years and older. 2. Intact consciousness and cognitive ability to understand and cooperate with the study protocol. 3. Capable of oral ingestion and self-administration of the study formula/placebo. 4. Meets at least one of the following priority recruitment criteria: 1. Screened positive for decline in at least one WHO ICOPE intrinsic capacity domain (locomotion, vitality, cognition, psychology, vision, or hearing). 2. Sarcopenia risk based on AWGS 2019 criteria: low handgrip strength (\<28 kg for men; \<18 kg for women), slow 6-meter gait speed (\<1.0 m/s), or Short Physical Performance Battery (SPPB) score ≤ 9. 5. Ability to attend scheduled hospital outpatient visits at baseline (Week 0) and Week 12. 6. Willing and able to provide written informed consent.
Exclusion criteria
1. Severe hepatic impairment (GPT/ALT \> 3 times the upper limit of normal, or a confirmed diagnosis of liver cirrhosis). 2. Severe renal impairment (serum creatinine ≥ 2.0 mg/dL, eGFR \< 30 mL/min/1.73m², or a confirmed history of renal failure, chronic kidney disease, uremia, or dialysis). 3. Confirmed clinical diagnosis of dementia. 4. Active malignant neoplasms currently undergoing active oncological therapy (chemotherapy, radiotherapy, or targeted therapy). 5. Current use of oral anticoagulant medication (Warfarin) due to potential interactions with fish oil and vitamin K2. 6. Known allergy or hypersensitivity to any ingredient of the study product (dairy, soy, or fish sources). 7. High-dose supplementation with whey protein, fish oil, or botanical extracts within the past 3 months. 8. Presence of an active middle-ear implant or cochlear implant (to eliminate confounding factors during hearing assessments).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Locomotion Measured by Short Physical Performance Battery (SPPB) | Baseline, Week 12 | 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. |
| Change in 6-Meter Gait Speed | Baseline, Week 12 | Measured by the 6-meter gait speed test in meters per second (m/s). Higher speed indicates better physical mobility |
| Change in Handgrip Strength | Baseline, Week 12 | Measured in kilograms (kg) using a handheld dynamometer on the dominant hand (maximum of two trials). Higher values indicate greater muscle strength. |
| Change in Nutritional Status by MNA-SF | Baseline, Week 12 | 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 |
| Change in Body Weight | Baseline, Week 12 | Measured in kilograms (kg) under fasting conditions. |
| Change in Calf Circumference | Baseline, Week 12 | Measured in centimeters (cm) at the widest part of the calf. Higher values indicate greater muscle mass reserve. |
| Change in Cognitive Function by MoCA | Baseline, Week 12 | Assessed by the Montreal Cognitive Assessment (MoCA). Scores range from 0 to 30, with higher scores reflecting better global cognitive performance. |
| Change in Depressive Symptoms by GDS-5 | Baseline, Week 12 | 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). |
| Change in Visual Impairment Status | Baseline, Week 12 | Evaluated based on WHO ICOPE Step 2 vision assessment criteria (classified as visual impairment: Yes or No). |
| Change in Hearing Impairment Status | Baseline, Week 12 | Evaluated using the whisper voice test based on WHO ICOPE Step 2 criteria (classified as hearing impairment: Yes or No). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Basic Activities of Daily Living by Barthel Index | Baseline, Week 12 | Scores range from 0 to 100, where higher scores indicate greater independence in physical functioning and personal care. |
| Change in Instrumental Activities of Daily Living by Lawton IADL Scale | Baseline, Week 12 | 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. |
| Change in Frailty Status by Fried CHS Phenotype | Baseline, Week 12 | 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). |
| Change in Clinical Frailty Scale (CFS) | Baseline, Week 12 | Measured using the Clinical Frailty Scale (CFS), with scores ranging from 1 to 9, where higher scores indicate greater frailty and a worse outcome. |
| Change in Quality of Life by SF-36 Health Survey | Baseline, Week 12 | 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). |
| Change in Skeletal Muscle Mass Index by Bioelectrical Impedance Analysis (BIA) | Baseline, Week 12 | 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. |
| Change in Visceral Fat Area by Bioelectrical Impedance Analysis | Baseline, Week 12 | 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. |
| Change in Body Fat Percentage by Bioelectrical Impedance Analysis | Baseline, Week 12 | 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. |
| Change in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) | Baseline, Week 12 | calculated by Homeostatic Model Assessment for Insulin Resistance, HOMA-IR |
| Change in Triglyceride-Glucose (TyG) Index | Baseline, Week 12 | calculated by Triglyceride-Glucose Index, TyG index. Higher values indicate greater metabolic and insulin resistance risk. |
| Change in Lipid Accumulation Product (LAP) | Baseline, Week 12 | calculated by Lipid Accumulation Product, LAP. Reflects visceral adiposity. |
| Change in Serum Growth Differentiation Factor-15 (GDF-15) | Baseline, Week 12 | measured by serum Growth Differentiation Factor-15, GDF-15, as a circulating biomarker of biological aging and mitochondrial stress. |
| Change in Fibrosis-4 (FIB-4) Index | Baseline, Week 12 | calculated by Fibrosis-4 Index, FIB-4. Used to estimate hepatic steatosis-associated fibrosis risk. |
| Change in Glycated Hemoglobin (HbA1c) | Baseline, Week 12 | measured by Glycated Hemoglobin, HbA1c |
| Change in High-Sensitivity C-Reactive Protein (hs-CRP) | Baseline, Week 12 | Measured in mg/L as a circulating marker of systemic low-grade inflammation. |
| Change in Serum 25-Hydroxyvitamin D [25(OH)D] | Baseline, Week 12 | Measured in ng/mL to reflect nutritional vitamin D status |
Countries
Taiwan
Contacts
CONTACTChih-Kuang Liang
Outcome results
None listed