Health Benefits of Nutraceutical Supplementation in Older Adults. (NCT07534878) | Clinical Trial Compass
CompletedPhase 4
Health Benefits of Nutraceutical Supplementation in Older Adults.
India23 participantsStarted 2025-12-24
Plain-language summary
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.
Who can participate
Age range50 Years – 80 Years
SexALL
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Inclusion Criteria:
* 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:
* Provide written informed consent
* Comply with study protocol requirements
* Read and write in English
Exclusion Criteria:
* 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 …