Age-related Functional Decline, Mild Cognitive Impairment
Conditions
Brief 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.
Interventions
DRUGPowder containing whey isolate and herbal extracts (30g sachet)
Powder containing whey isolate and herbal extracts (30g sachet) Mix with water and consume twice daily before meals.
Sponsors
GPLIFE HEALTHCARE PRIVATE LIMITED
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 6-minute walk test | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 1-RM strength test (knee extension) | pre-intervention and Week 8 | Maximum weight (kg) lifted using leg press equipment to assess muscle strength |
| DXA scan | pre-intervention and Week 8. | Muscleb volume will be measured using Dual-energy X-ray Absorptiometry (DXA) |
| Cognitive performance assessed using NIH Toolbox Fluid Composite Score | pre-intervention and Week 8 | Executive function, attention, and working memory assessed using NIH Toolbox Fluid Composite T-score |
| Cognitive biomarker levels (p-tau181) | pre-intervention and Week 8 | Serum levels of phosphorylated tau (p-tau181) measured as a biomarker of cognitive function. |
| Change in BMI | pre-intervention and Week 8 | BMI (kg/m²) |
| Incidence of adverse events (AEs/SAEs) | Baseline (Week 0) through Week 8 | Number and severity of adverse and serious adverse events recorded during the study. |
| Tolerability of the nutraceutical intervention | Baseline (Week 0) through Week 8 | Assessment of subject-reported tolerability throughout the study. |
| Participant compliance to study intervention | Baseline (Week 0) through Week 8 | Compliance assessed based on participant Compliance Diary |
| Change in complete blood count | Pre intervention and week 8 | Complete blood count parameters like RBC, WBC count |
| Change in Renal function test | Pre intervention and week 8 | Renal function test parameters include Serum Bilirubin - Total,Serum Total Protein,Serum Bilirubin - Direct |
| Change in Thyroid profile | pre intervention and week 8 | Thyroid profile Parameters Include TSH ,T3.T4 |
| Change in Lipid Profile | Pre intervention and Week 8 | Lipid Profile Parameters Include Cholesterol Level, serum Triglycerides,HDL Cholesterol, LDL cholesterol |
| Change in Electrolytes | Pre Intervention and Week 8 | Electrolytes parameters include Sodium,Potassium,Chlorides |
| Change in Serum concentration of MDA marker | Pre-intervention and Week 8 | MDA Marker |
| Change in Serum concentration of SOD Marker | Pre-Intervention and Week 8 | SOD Marker |
| Change in Serum Concentration of NAD+ levels | Pre-intervention and Week 8 | NAD+ Marker |
| Change in serum concentration of hs-CRP | Pre-intervention and week 8 | hs-CRP Level |
| change in Serum concentration of TNF- alpha | Pre-intervention and Week 8 | TNF-alpha Level |
| Change in serum concentration of IL-6 | Pre-intervention and Week 8 | IL-6 Level |
| Change in level of CD4/CD8 Ratio | Pre-intervention and Week 8 | CD4/CD8 Ratio |
| Change in CD45 | Pre-intervention and Week 8 | CD45 levels |
| Change in CD3 | Pre-intervention and Week 8 | CD3 Levels |
| Change in CD8 | Pre-intervention and Week 8 | CD8 Level |
| Change in T cells | Pre-intervention and Week 8 | T cells Levels |
| Change in B cells | pre-intervention and Week 8 | B cells levels |
| Change in NK cells | Pre-intervention and Week 8 | NK cells Levels |
| Change in lymphocyte/neutrophil ratio | Pre-intervention and Week 8 | lymphocyte/neutrophil ratio |
| Change in CD4 | Pre-intervention and Week 8 | CD4 levels |
| Change in Liver Function test | Pre-intervention and Week 8 | Liver Function test include serum Creatinine , Serum Urea, Serum uric Acid |
Countries
India
Outcome results
None listed