Gplife Healthcare Private Limited
Surat, Gujarat, 395010, India
NCT Number: NCT07534878
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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Notify Me50 year–80 year
All sexes
Interventional
Phase 4
Surat, Gujarat, 395010, India
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Participants with:
Exclusion criteria
Powder containing whey isolate and herbal extracts (30g sachet) Mix with water and consume twice daily before meals.
Time frame: 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.
Time frame: pre-intervention and Week 8
Maximum weight (kg) lifted using leg press equipment to assess muscle strength
Time frame: pre-intervention and Week 8.
Muscleb volume will be measured using Dual-energy X-ray Absorptiometry (DXA)
Time frame: pre-intervention and Week 8
Executive function, attention, and working memory assessed using NIH Toolbox Fluid Composite T-score
Time frame: pre-intervention and Week 8
Serum levels of phosphorylated tau (p-tau181) measured as a biomarker of cognitive function.
Time frame: pre-intervention and Week 8
BMI (kg/m²)
Time frame: Baseline (Week 0) through Week 8
Number and severity of adverse and serious adverse events recorded during the study.
Time frame: Baseline (Week 0) through Week 8
Assessment of subject-reported tolerability throughout the study.
Time frame: Baseline (Week 0) through Week 8
Compliance assessed based on participant Compliance Diary
Time frame: Pre intervention and week 8
Complete blood count parameters like RBC, WBC count
Time frame: Pre intervention and week 8
Renal function test parameters include Serum Bilirubin - Total,Serum Total Protein,Serum Bilirubin - Direct
Time frame: pre intervention and week 8
Thyroid profile Parameters Include TSH ,T3.T4
Time frame: Pre intervention and Week 8
Lipid Profile Parameters Include Cholesterol Level, serum Triglycerides,HDL Cholesterol, LDL cholesterol
Time frame: Pre Intervention and Week 8
Electrolytes parameters include Sodium,Potassium,Chlorides
Time frame: Pre-intervention and Week 8
MDA Marker
Time frame: Pre-Intervention and Week 8
SOD Marker
Time frame: Pre-intervention and Week 8
NAD+ Marker
Time frame: Pre-intervention and week 8
hs-CRP Level
Time frame: Pre-intervention and Week 8
TNF-alpha Level
Time frame: Pre-intervention and Week 8
IL-6 Level
Time frame: Pre-intervention and Week 8
CD4/CD8 Ratio
Time frame: Pre-intervention and Week 8
CD45 levels
Time frame: Pre-intervention and Week 8
CD3 Levels
Time frame: Pre-intervention and Week 8
CD8 Level
Time frame: Pre-intervention and Week 8
T cells Levels
Time frame: pre-intervention and Week 8
B cells levels
Time frame: Pre-intervention and Week 8
NK cells Levels
Time frame: Pre-intervention and Week 8
lymphocyte/neutrophil ratio
Time frame: Pre-intervention and Week 8
CD4 levels
Time frame: Pre-intervention and Week 8
Liver Function test include serum Creatinine , Serum Urea, Serum uric Acid
GPLIFE HEALTHCARE PRIVATE LIMITED
Industry
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.
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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