Health Trials

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

ConditionsSarcopeniaIntrinsic Capacity
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorNational Yang Ming Chiao Tung University

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Screened positive for decline in at least one WHO ICOPE intrinsic capacity domain (locomotion, vitality, cognition, psychology, vision, or hearing).

Disqualifiers

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).

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

70 Participants
are divided into 2 treatment groups
Group A: Experimental: Multi-Component Nutritional Formula GroupExperimental treatment 1 intervention
Group B: Placebo Comparator: Matched Placebo GroupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame
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

Time frame
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.

Time frame
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

Time frame
Baseline, Week 12

Secondary outcomes

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.

Time frame
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.

Time frame
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).

Time frame
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.

Time frame
Baseline, Week 12

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

National Yang Ming Chiao Tung University

Lead sponsor

Kaohsiung Veterans General Hospital.

Collaborator

Taiwan Association of Integrated Care

Collaborator

Source ClinicalTrials.gov

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