Health Benefits of Nutraceutical Supplementation in Older Adults.

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.

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.

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 allergy to any component of the nutraceutical kit
• Sedentary individuals unable or not advised to undergo resistance training as per protocol
• Clinically relevant macro- or micronutrient deficiency (as per investigator discretion)
• Pregnant or lactating women
• Women of childbearing potential not using adequate contraception or with a positive urine pregnancy test
• Current use of herbal products, nutraceuticals, Ayurvedic formulations, dietary supplements, or vitamin/mineral supplements and unwilling to discontinue during the study
• Any other condition or abnormal laboratory finding that, in the investigator's opinion, may interfere with study results or participant safety