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.

Study Overview

• Status: Completed
• Conditions: Mild Cognitive Impairment; Age-related Functional Decline
• Intervention / Treatment: Drug: Powder containing whey isolate and herbal extracts (30g sachet)

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Phase 4

Contacts and Locations

Study Locations

• India
  • Gujarat
    • Surat, Gujarat, India, 395010
      • Gplife Healthcare Private Limited

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Powder containing whey isolate and herbal extracts (30g sachet)	Drug: Powder 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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)	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

Collaborators and Investigators

• Sponsor: GPLIFE HEALTHCARE PRIVATE LIMITED

Study record dates

Study Major Dates

• Study Start (Actual): December 24, 2025
• Primary Completion (Actual): January 31, 2026
• Study Completion (Actual): March 2, 2026

Study Registration Dates

• First Submitted: March 10, 2026
• First Submitted That Met QC Criteria: April 10, 2026
• First Posted (Actual): April 16, 2026

Study Record Updates

• Last Update Posted (Actual): April 16, 2026
• Last Update Submitted That Met QC Criteria: April 10, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction
• Other Study ID Numbers: GP/CT/25-26/001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No