CTRI/2025/12/099643已完成Unknown
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30日最近更新:
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 发起方
- 入组人数
- 23
- 试验地点
- 1
研究概览
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
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 50.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Participants with- i)Generally good health with life expectance greater than equal to 5 years.
- •ii)Male and female participants aged between 50 to 80 years having a BMI between 25 to 35 kg per meter Square.
- •iii)Health not severely compromised that is no life threatening illness or disability.
- •2.Participants with- i)Intrinsic Capacity score showing mild to moderate decline and ii)Short Physical Performance Battery SPPB score between 9 to 11 and iii)Montreal Cognitive Assessment (MoCA) greater than 20 and less than equal to
- •3.Participants with or without comorbidity.
- •If comorbidity is present, it should be on a stable regimen that is same drug and same dose for at least 12 weeks before the screening visit.
- •4.Participants are able and willing to provide written informed consent, comply with the study protocol requirements, and can read and write in English.
排除标准
- •1.Severe or uncontrolled chronic disease osteoarthritis, advanced cardiovascular disease, kidney failure, uncontrolled diabetes, severe COPD, terminal cancer.
- •2.Physical disability requiring a walker or wheelchair.
- •3.Diagnosed dementia or cognitive impairment preventing protocol compliance.
- •4.Acute infection or illness within 3 months before enrollment.
- •5.Unstable medical conditions example recent MI, unstable angina, uncontrolled hypertension.
- •6.Major surgery in the past 6 months or planned during study.
- •7.Severe psychiatric disorders unless well controlled.
- •8.Substance abuse within past 6 months.
- •9.Participation in another clinical trial within the last 6 months.
- •10.Known allergy to any component of the nutraceutical kit.
- •11.Participants with sedentary lifestyles are not able or not advised to undergo the resistance training as per protocol.
- •12.Any clinically relevant macro or micro-nutrient deficiency as per investigator discretion.
- •13.Pregnant women, lactating women, women of child bearing potential not following adequate contraceptive measures, women who were found positive for urine pregnancy test.
- •14.Participants who are currently taking any herbal products, nutraceuticals, Ayurvedic formulations, dietary supplements, or vitamin or mineral supplements and are unwilling to discontinue their use for the duration of the study.
- •15.According to the investigator, any other illness or abnormal laboratory investigations would interfere directly with the study results or jeopardize the participants health.
研究者
Dr Ram Mundhe
Gunjkar Multispeciality Hospital
研究点 (1)
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