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SarcopeniaNCT07815158

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

A study testing Multi-Component Nutritional Formula in people with Sarcopenia and Intrinsic Capacity, run by National Yang Ming Chiao Tung University at 1 site in Taiwan.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
Sarcopenia, Intrinsic Capacity
What is being tested?
Multi-Component Nutritional Formula
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
70 participants
Where
1 siteTaiwan
Study dates
31 Aug 2026to 31 Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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).

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Taiwan1 site
  • Kaohsiung Veterans General Hospital

    Kaohsiung City, 813414

Other trials in Taiwan

About this study

Official 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

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.

Read the 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.

Being tested
Multi-Component Nutritional Formula, matched placebo
Keywords
Sarcopenia, frailty, intrinsic capacity, Physical Function, Metabolic Biomarkers, Multi-Component Nutritional Supplement
Medical subject headings
Sarcopenia, Frailty

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Multi-Component Nutritional FormulaDietary 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 placeboDietary 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.

Study groups in NCT07815158
Study groupRoleWhat they receive
Experimental: Multi-Component Nutritional Formula GroupExperimentalParticipants in this group receive the active 18-component multi-component nutritional formula daily for 12 consecutive weeks (84 days) while maintaining their routine diet and physical activity.
Receives: Dietary Supplement: Multi-Component Nutritional Formula
Placebo Comparator: Matched Placebo GroupPlacebo comparatorParticipants in this group receive an appearance-, flavor-, and taste-matched placebo powder daily for 12 consecutive weeks (84 days) while maintaining their routine diet and physical activity.
Receives: Dietary Supplement: matched placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline, Week 12

  2. 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

    Measured: Baseline, Week 12

  3. 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.

    Measured: Baseline, Week 12

  4. 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

    Measured: Baseline, Week 12

  5. Change in Body Weight

    Measured in kilograms (kg) under fasting conditions.

    Measured: Baseline, Week 12

  6. Change in Calf Circumference

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

    Measured: Baseline, Week 12

  7. 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.

    Measured: Baseline, Week 12

  8. 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).

    Measured: Baseline, Week 12

  9. Change in Visual Impairment Status

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

    Measured: Baseline, Week 12

  10. 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).

    Measured: Baseline, Week 12

Secondary outcomes (16)
  1. 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.

    Measured: Baseline, Week 12

  2. 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.

    Measured: Baseline, Week 12

  3. 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).

    Measured: Baseline, Week 12

  4. 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.

    Measured: Baseline, Week 12

  5. 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).

    Measured: Baseline, Week 12

  6. 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.

    Measured: Baseline, Week 12

  7. 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.

    Measured: Baseline, Week 12

  8. 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.

    Measured: Baseline, Week 12

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

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

    Measured: Baseline, Week 12

  10. Change in Triglyceride-Glucose (TyG) Index

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

    Measured: Baseline, Week 12

  11. Change in Lipid Accumulation Product (LAP)

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

    Measured: Baseline, Week 12

  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.

    Measured: Baseline, Week 12

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

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

    Measured: Baseline, Week 12

  14. Change in Glycated Hemoglobin (HbA1c)

    measured by Glycated Hemoglobin, HbA1c

    Measured: Baseline, Week 12

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

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

    Measured: Baseline, Week 12

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

    Measured in ng/mL to reflect nutritional vitamin D status

    Measured: Baseline, Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Sep 2026
  2. Study start31 Aug 2026 (estimated)
  3. Primary completion15 Dec 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
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.
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
70 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07815158
Sponsor's protocol ID
26-CT7-26(260624-2)
Status last verified
Aug 2026
First submitted
21 Aug 2026
Last updated
11 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Multi-Component Nutritional Formula in people with Sarcopenia and Intrinsic Capacity, run by National Yang Ming Chiao Tung University at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Chih-Kuang Liang (07-3422121 ext. 72091, Ck.vghks@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Locomotion Measured by Short Physical Performance Battery (SPPB) (time frame: Baseline, Week 12). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.

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