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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Powder containing whey isolate and herbal extracts (30g sachet) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Powder containing whey isolate and herbal extracts (30g sachet) | Drug | Powder containing whey isolate and herbal extracts (30g sachet) Mix with water and consume twice daily before meals. |
| Measure | Description | Time Frame |
|---|---|---|
| 6-minute walk test | Distance walked in meters during the 6-minute walk test (6MWT) will be assessed as a measure of functional exercise capacity. | pre-intervention and Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| 1-RM strength test (knee extension) | Maximum weight (kg) lifted using leg press equipment to assess muscle strength | pre-intervention and Week 8 |
| DXA scan | Muscleb volume will be measured using Dual-energy X-ray Absorptiometry (DXA) |
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Inclusion Criteria:
Participants with:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gplife Healthcare Private Limited | Surat | Gujarat | 395010 | India |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 19, 2025 | Mar 10, 2026 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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| pre-intervention and Week 8. |
| Cognitive performance assessed using NIH Toolbox Fluid Composite Score | Executive function, attention, and working memory assessed using NIH Toolbox Fluid Composite T-score | pre-intervention and Week 8 |
| Cognitive biomarker levels (p-tau181) | Serum levels of phosphorylated tau (p-tau181) measured as a biomarker of cognitive function. | pre-intervention and Week 8 |
| Change in BMI | BMI (kg/m²) | pre-intervention and Week 8 |
| Incidence of adverse events (AEs/SAEs) | Number and severity of adverse and serious adverse events recorded during the study. | Baseline (Week 0) through Week 8 |
| Tolerability of the nutraceutical intervention | Assessment of subject-reported tolerability throughout the study. | Baseline (Week 0) through Week 8 |
| Participant compliance to study intervention | Compliance assessed based on participant Compliance Diary | Baseline (Week 0) through Week 8 |
| Change in complete blood count | Complete blood count parameters like RBC, WBC count | Pre intervention and week 8 |
| Change in Renal function test | Renal function test parameters include Serum Bilirubin - Total,Serum Total Protein,Serum Bilirubin - Direct | Pre intervention and week 8 |
| Change in Thyroid profile | Thyroid profile Parameters Include TSH ,T3.T4 | pre intervention and week 8 |
| Change in Lipid Profile | Lipid Profile Parameters Include Cholesterol Level, serum Triglycerides,HDL Cholesterol, LDL cholesterol | Pre intervention and Week 8 |
| Change in Electrolytes | Electrolytes parameters include Sodium,Potassium,Chlorides | Pre Intervention and Week 8 |
| Change in Serum concentration of MDA marker | MDA Marker | Pre-intervention and Week 8 |
| Change in Serum concentration of SOD Marker | SOD Marker | Pre-Intervention and Week 8 |
| Change in Serum Concentration of NAD+ levels | NAD+ Marker | Pre-intervention and Week 8 |
| Change in serum concentration of hs-CRP | hs-CRP Level | Pre-intervention and week 8 |
| change in Serum concentration of TNF- alpha | TNF-alpha Level | Pre-intervention and Week 8 |
| Change in serum concentration of IL-6 | IL-6 Level | Pre-intervention and Week 8 |
| Change in level of CD4/CD8 Ratio | CD4/CD8 Ratio | Pre-intervention and Week 8 |
| Change in CD45 | CD45 levels | Pre-intervention and Week 8 |
| Change in CD3 | CD3 Levels | Pre-intervention and Week 8 |
| Change in CD8 | CD8 Level | Pre-intervention and Week 8 |
| Change in T cells | T cells Levels | Pre-intervention and Week 8 |
| Change in B cells | B cells levels | pre-intervention and Week 8 |
| Change in NK cells | NK cells Levels | Pre-intervention and Week 8 |
| Change in lymphocyte/neutrophil ratio | lymphocyte/neutrophil ratio | Pre-intervention and Week 8 |
| Change in CD4 | CD4 levels | Pre-intervention and Week 8 |
| Change in Liver Function test | Liver Function test include serum Creatinine , Serum Urea, Serum uric Acid | Pre-intervention and Week 8 |