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.

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.

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).