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NCT Number: NCT07815158

Multi-Component Nutrition, Intrinsic Capacity, and Physical Function in Older Adults

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.

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Key information

Conditions

Sarcopenia Atrophy Frailty Intrinsic Capacity Muscular Atrophy Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kaohsiung Veterans General Hospital

Kaohsiung City, 813414, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age 65 years and older.
  • Intact consciousness and cognitive ability to understand and cooperate with the study protocol.
  • Capable of oral ingestion and self-administration of the study formula/placebo.
  • Meets at least one of the following priority recruitment criteria:
  • Screened positive for decline in at least one WHO ICOPE intrinsic capacity domain (locomotion, vitality, cognition, psychology, vision, or hearing).
  • 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.
  • Ability to attend scheduled hospital outpatient visits at baseline (Week 0) and Week 12.
  • Willing and able to provide written informed consent.

Exclusion criteria

  • Severe hepatic impairment (GPT/ALT > 3 times the upper limit of normal, or a confirmed diagnosis of liver cirrhosis).
  • 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).
  • Confirmed clinical diagnosis of dementia.
  • Active malignant neoplasms currently undergoing active oncological therapy (chemotherapy, radiotherapy, or targeted therapy).
  • Current use of oral anticoagulant medication (Warfarin) due to potential interactions with fish oil and vitamin K2.
  • Known allergy or hypersensitivity to any ingredient of the study product (dairy, soy, or fish sources).
  • High-dose supplementation with whey protein, fish oil, or botanical extracts within the past 3 months.
  • Presence of an active middle-ear implant or cochlear implant (to eliminate confounding factors during hearing assessments).

Treatment and study plan

Multi-Component Nutritional Formula

Dietary Supplement

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).

Matched Placebo

Dietary Supplement

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.

Primary outcomes

  1. Change in Locomotion Measured by Short Physical Performance Battery (SPPB)

    Time frame: 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.

  2. Change in 6-Meter Gait Speed

    Time frame: Baseline, Week 12

    Measured by the 6-meter gait speed test in meters per second (m/s). Higher speed indicates better physical mobility

  3. Change in Handgrip Strength

    Time frame: 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.

  4. Change in Nutritional Status by MNA-SF

    Time frame: 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

  5. Change in Body Weight

    Time frame: Baseline, Week 12

    Measured in kilograms (kg) under fasting conditions.

  6. Change in Calf Circumference

    Time frame: Baseline, Week 12

    Measured in centimeters (cm) at the widest part of the calf. Higher values indicate greater muscle mass reserve.

  7. Change in Cognitive Function by MoCA

    Time frame: Baseline, Week 12

    Assessed by the Montreal Cognitive Assessment (MoCA). Scores range from 0 to 30, with higher scores reflecting better global cognitive performance.

  8. Change in Depressive Symptoms by GDS-5

    Time frame: 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).

  9. Change in Visual Impairment Status

    Time frame: Baseline, Week 12

    Evaluated based on WHO ICOPE Step 2 vision assessment criteria (classified as visual impairment: Yes or No).

  10. Change in Hearing Impairment Status

    Time frame: Baseline, Week 12

    Evaluated using the whisper voice test based on WHO ICOPE Step 2 criteria (classified as hearing impairment: Yes or No).

Secondary outcomes

  1. Change in Basic Activities of Daily Living by Barthel Index

    Time frame: Baseline, Week 12

    Scores range from 0 to 100, where higher scores indicate greater independence in physical functioning and personal care.

  2. Change in Instrumental Activities of Daily Living by Lawton IADL Scale

    Time frame: 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.

  3. Change in Frailty Status by Fried CHS Phenotype

    Time frame: 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).

  4. Change in Clinical Frailty Scale (CFS)

    Time frame: 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.

  5. Change in Quality of Life by SF-36 Health Survey

    Time frame: 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).

  6. Change in Skeletal Muscle Mass Index by Bioelectrical Impedance Analysis (BIA)

    Time frame: 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.

  7. Change in Visceral Fat Area by Bioelectrical Impedance Analysis

    Time frame: 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.

  8. Change in Body Fat Percentage by Bioelectrical Impedance Analysis

    Time frame: 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.

  9. Change in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)

    Time frame: Baseline, Week 12

    calculated by Homeostatic Model Assessment for Insulin Resistance, HOMA-IR

  10. Change in Triglyceride-Glucose (TyG) Index

    Time frame: Baseline, Week 12

    calculated by Triglyceride-Glucose Index, TyG index. Higher values indicate greater metabolic and insulin resistance risk.

  11. Change in Lipid Accumulation Product (LAP)

    Time frame: Baseline, Week 12

    calculated by Lipid Accumulation Product, LAP. Reflects visceral adiposity.

  12. Change in Serum Growth Differentiation Factor-15 (GDF-15)

    Time frame: Baseline, Week 12

    measured by serum Growth Differentiation Factor-15, GDF-15, as a circulating biomarker of biological aging and mitochondrial stress.

  13. Change in Fibrosis-4 (FIB-4) Index

    Time frame: Baseline, Week 12

    calculated by Fibrosis-4 Index, FIB-4. Used to estimate hepatic steatosis-associated fibrosis risk.

  14. Change in Glycated Hemoglobin (HbA1c)

    Time frame: Baseline, Week 12

    measured by Glycated Hemoglobin, HbA1c

  15. Change in High-Sensitivity C-Reactive Protein (hs-CRP)

    Time frame: Baseline, Week 12

    Measured in mg/L as a circulating marker of systemic low-grade inflammation.

  16. Change in Serum 25-Hydroxyvitamin D [25(OH)D]

    Time frame: Baseline, Week 12

    Measured in ng/mL to reflect nutritional vitamin D status

Study contacts

Contact information is provided by the study sponsor or research team.

Chih-Kuang Liang

CONTACT

[email protected]

07-3422121 ext. 72091

Sponsors and collaborators

Lead sponsor

National Yang Ming Chiao Tung University

Other

Collaborators

  • Kaohsiung Veterans General Hospital.
  • Taiwan Association of Integrated Care

Registry information

Official study title

Effects of a Multi-Component Nutritional Formula on WHO ICOPE Intrinsic Capacity Domains, Physical Function, and Metabolic Biomarkers in Community-Dwelling Older Adults: A Double-Blind Randomized Controlled Trial

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Sep 11, 2026
Registry last updated
Sep 11, 2026

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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