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

NCT07815158 | Not Yet Recruiting

• 1 other identifier: 26-CT7-26(260624-2)
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Sarcopenia; Intrinsic Capacity

Keywords

Sarcopenia; frailty; intrinsic capacity; Physical Function; Metabolic Biomarkers; Multi-Component Nutritional Supplement

Outcome Measures

Primary Outcomes (10)

• 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 Outcomes (16)

• Change in Basic Activities of Daily Living by Barthel Index

  Baseline, Week 12

• Change in Instrumental Activities of Daily Living by Lawton IADL Scale

  Baseline, Week 12

• Change in Frailty Status by Fried CHS Phenotype

  Baseline, Week 12

• Change in Clinical Frailty Scale (CFS)

  Baseline, Week 12

• Change in Quality of Life by SF-36 Health Survey

  Baseline, Week 12

Study Arms (2)

Experimental: Multi-Component Nutritional Formula Group

EXPERIMENTAL

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

Placebo Comparator: Matched Placebo Group

PLACEBO COMPARATOR

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

Interventions

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).

Experimental: Multi-Component Nutritional Formula Group

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.

Placebo Comparator: Matched Placebo Group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• National Yang Ming Chiao Tung University: lead
• Kaohsiung Veterans General Hospital.: collaborator
• Taiwan Association of Integrated Care: collaborator

Study Sites (1)

Kaohsiung Veterans General Hospital

Kaohsiung City, 813414, Taiwan

Location

MeSH Terms

Conditions

Sarcopenia; Frailty

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pathologic Processes

Central Study Contacts

Chih-Kuang Liang

CONTACT

07-3422121; Ck.vghks@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 21, 2026
• First Posted: September 11, 2026
• Study Start: August 31, 2026
• Primary Completion (Estimated): December 15, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: September 11, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)