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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Change in Locomotion Measured by Short Physical Performance Battery (SPPB)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 ≤
- •Ability to attend scheduled hospital outpatient visits at baseline (Week 0) and Week
- •Willing and able to provide written informed consent.
排除标准
- •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 K
- •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).
研究组 & 干预措施
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.
干预措施: Multi-Component Nutritional Formula (Dietary Supplement)
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.
干预措施: matched placebo (Dietary Supplement)
结局指标
主要结局
Change in Locomotion Measured by Short Physical Performance Battery (SPPB)
时间窗: Baseline, Week 12
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.
Change in 6-Meter Gait Speed
时间窗: Baseline, Week 12
Measured by the 6-meter gait speed test in meters per second (m/s). Higher speed indicates better physical mobility
Change in Handgrip Strength
时间窗: Baseline, Week 12
Measured in kilograms (kg) using a handheld dynamometer on the dominant hand (maximum of two trials). Higher values indicate greater muscle strength.
Change in Nutritional Status by MNA-SF
时间窗: Baseline, Week 12
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
Change in Body Weight
时间窗: Baseline, Week 12
Measured in kilograms (kg) under fasting conditions.
Change in Calf Circumference
时间窗: Baseline, Week 12
Measured in centimeters (cm) at the widest part of the calf. Higher values indicate greater muscle mass reserve.
Change in Cognitive Function by MoCA
时间窗: Baseline, Week 12
Assessed by the Montreal Cognitive Assessment (MoCA). Scores range from 0 to 30, with higher scores reflecting better global cognitive performance.
Change in Depressive Symptoms by GDS-5
时间窗: Baseline, Week 12
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).
Change in Visual Impairment Status
时间窗: Baseline, Week 12
Evaluated based on WHO ICOPE Step 2 vision assessment criteria (classified as visual impairment: Yes or No).
Change in Hearing Impairment Status
时间窗: Baseline, Week 12
Evaluated using the whisper voice test based on WHO ICOPE Step 2 criteria (classified as hearing impairment: Yes or No).
次要结局
- 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)
- Change in Skeletal Muscle Mass Index by Bioelectrical Impedance Analysis (BIA)(Baseline, Week 12)
- Change in Visceral Fat Area by Bioelectrical Impedance Analysis(Baseline, Week 12)
- Change in Body Fat Percentage by Bioelectrical Impedance Analysis(Baseline, Week 12)
- Change in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)(Baseline, Week 12)
- Change in Triglyceride-Glucose (TyG) Index(Baseline, Week 12)
- Change in Lipid Accumulation Product (LAP)(Baseline, Week 12)
- Change in Serum Growth Differentiation Factor-15 (GDF-15)(Baseline, Week 12)
- Change in Fibrosis-4 (FIB-4) Index(Baseline, Week 12)
- Change in Glycated Hemoglobin (HbA1c)(Baseline, Week 12)
- Change in High-Sensitivity C-Reactive Protein (hs-CRP)(Baseline, Week 12)
- Change in Serum 25-Hydroxyvitamin D [25(OH)D](Baseline, Week 12)