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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Sarcopenia; Intrinsic Capacity
• Intervention / Treatment: Dietary supplement: Multi-Component Nutritional Formula; Dietary supplement: matched placebo

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.

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Chih-Kuang Liang; Phone Number: 72091 07-3422121; Email: Ck.vghks@gmail.com

Study Locations

• Taiwan
  • Kaohsiung City, Taiwan, 813414
    • Kaohsiung Veterans General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental: Multi-Component Nutritional Formula Group; Participants 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.	Dietary supplement: Multi-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).
Placebo Comparator: Placebo Comparator: Matched Placebo Group; Participants 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.	Dietary supplement: matched 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	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.	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	Baseline, Week 12
Change in Body Weight	Measured in kilograms (kg) under fasting conditions.	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.	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.	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).	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).	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).	Baseline, Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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).	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.	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).	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.	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.	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.	Baseline, Week 12
Change in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)	calculated by Homeostatic Model Assessment for Insulin Resistance, HOMA-IR	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.	Baseline, Week 12
Change in Lipid Accumulation Product (LAP)	calculated by Lipid Accumulation Product, LAP. Reflects visceral adiposity.	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.	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.	Baseline, Week 12
Change in Glycated Hemoglobin (HbA1c)	measured by Glycated Hemoglobin, HbA1c	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.	Baseline, Week 12
Change in Serum 25-Hydroxyvitamin D [25(OH)D]	Measured in ng/mL to reflect nutritional vitamin D status	Baseline, Week 12

Collaborators and Investigators

• Sponsor: National Yang Ming Chiao Tung University
• Collaborators: Kaohsiung Veterans General Hospital.; Taiwan Association of Integrated Care

Study record dates

Study Major Dates

• Study Start (Estimated): August 31, 2026
• Primary Completion (Estimated): December 15, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: August 21, 2026
• First Submitted That Met QC Criteria: September 9, 2026
• First Posted (Actual): September 11, 2026

Study Record Updates

• Last Update Posted (Actual): September 11, 2026
• Last Update Submitted That Met QC Criteria: September 9, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Keywords: frailty; Physical Function; Sarcopenia; intrinsic capacity; Metabolic Biomarkers; Multi-Component Nutritional Supplement
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Neuromuscular Manifestations; Pathologic Processes; Pathological Conditions, Anatomical; Muscular Atrophy; Atrophy; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Frailty; Sarcopenia
• Other Study ID Numbers: 26-CT7-26(260624-2)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No