NCT07534878
已完成
4 期
A Proof-of-concept Clinical Study to Evaluate the Impact of a Combination Nutraceutical Kit on Muscle Function, Cognitive Performance, and Immune Resilience in Older Adults.
GPLIFE HEALTHCARE PRIVATE LIMITED1 个研究点 分布在 1 个国家目标入组 23 人开始时间: 2025年12月24日最近更新:
概览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- GPLIFE HEALTHCARE PRIVATE LIMITED
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- 6-minute walk test
概览
简要总结
This study examines a multi-ingredient nutraceutical designed to support several areas of health in older adults, including muscle strength, cognitive function, immune response, and inflammation. Unlike single-drug treatments, the ingredients work together through complementary mechanisms across different biological systems. Since this combined approach has not been clinically tested before, the trial will provide early evidence on functional outcomes and biomarker changes. The main goal is to measure improvements in muscle performance, while secondary goals include evaluating effects on cognition, immunity, inflammation, safety, and tolerability in older adults.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Generally healthy participants with a life expectancy ≥ 5 years
- •Male and female participants aged 50 to 80 years
- •Body Mass Index (BMI) between 25 to 35 kg/m²
- •Health not severely compromised (no life-threatening illness or disability)
- •Participants with:
- •Intrinsic Capacity score showing mild to moderate decline
- •Short Physical Performance Battery (SPPB) score between 9 to 11
- •Montreal Cognitive Assessment (MoCA) score \> 20 and ≤ 25
- •Participants with or without comorbidities; if present, must be on a stable treatment regimen (same drug and dose) for at least 12 weeks prior to screening
- •Able and willing to:
排除标准
- •Severe or uncontrolled chronic diseases (e.g., severe osteoarthritis, advanced cardiovascular disease, kidney failure, uncontrolled diabetes, severe COPD, terminal cancer)
- •Physical disability requiring a walker or wheelchair
- •Diagnosed dementia or cognitive impairment preventing protocol compliance
- •Acute infection or illness within 3 months prior to enrollment
- •Unstable medical conditions (e.g., recent myocardial infarction, unstable angina, uncontrolled hypertension)
- •Major surgery within the past 6 months or planned during the study
- •Severe psychiatric disorders unless well controlled
- •Substance abuse within the past 6 months
- •Participation in another clinical trial within the last 6 months
- •Known allergy to any component of the nutraceutical kit
研究组 & 干预措施
Powder containing whey isolate and herbal extracts (30g sachet)
Experimental
干预措施: Powder containing whey isolate and herbal extracts (30g sachet) (Drug)
结局指标
主要结局
6-minute walk test
时间窗: pre-intervention and Week 8
Distance walked in meters during the 6-minute walk test (6MWT) will be assessed as a measure of functional exercise capacity.
次要结局
- 1-RM strength test (knee extension)(pre-intervention and Week 8)
- DXA scan(pre-intervention and Week 8.)
- Cognitive performance assessed using NIH Toolbox Fluid Composite Score(pre-intervention and Week 8)
- Cognitive biomarker levels (p-tau181)(pre-intervention and Week 8)
- Change in BMI(pre-intervention and Week 8)
- Incidence of adverse events (AEs/SAEs)(Baseline (Week 0) through Week 8)
- Tolerability of the nutraceutical intervention(Baseline (Week 0) through Week 8)
- Participant compliance to study intervention(Baseline (Week 0) through Week 8)
- Change in complete blood count(Pre intervention and week 8)
- Change in Renal function test(Pre intervention and week 8)
- Change in Thyroid profile(pre intervention and week 8)
- Change in Lipid Profile(Pre intervention and Week 8)
- Change in Electrolytes(Pre Intervention and Week 8)
- Change in Serum concentration of MDA marker(Pre-intervention and Week 8)
- Change in Serum concentration of SOD Marker(Pre-Intervention and Week 8)
- Change in Serum Concentration of NAD+ levels(Pre-intervention and Week 8)
- Change in serum concentration of hs-CRP(Pre-intervention and week 8)
- change in Serum concentration of TNF- alpha(Pre-intervention and Week 8)
- Change in serum concentration of IL-6(Pre-intervention and Week 8)
- Change in level of CD4/CD8 Ratio(Pre-intervention and Week 8)
- Change in CD45(Pre-intervention and Week 8)
- Change in CD3(Pre-intervention and Week 8)
- Change in CD8(Pre-intervention and Week 8)
- Change in T cells(Pre-intervention and Week 8)
- Change in B cells(pre-intervention and Week 8)
- Change in NK cells(Pre-intervention and Week 8)
- Change in lymphocyte/neutrophil ratio(Pre-intervention and Week 8)
- Change in CD4(Pre-intervention and Week 8)
- Change in Liver Function test(Pre-intervention and Week 8)
研究者
研究点 (1)
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