Health Benefits of Nutraceutical Supplementation in Older Adults.

April 10, 2026 updated by: GPLIFE HEALTHCARE PRIVATE LIMITED

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
23

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
6-minute walk test
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.
pre-intervention and Week 8

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
1-RM strength test (knee extension)
Time Frame: pre-intervention and Week 8
Maximum weight (kg) lifted using leg press equipment to assess muscle strength
pre-intervention and Week 8
DXA scan
Time Frame: pre-intervention and Week 8.
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
Time Frame: pre-intervention and Week 8
Executive function, attention, and working memory assessed using NIH Toolbox Fluid Composite T-score
pre-intervention and Week 8
Cognitive biomarker levels (p-tau181)
Time Frame: pre-intervention and Week 8
Serum levels of phosphorylated tau (p-tau181) measured as a biomarker of cognitive function.
pre-intervention and Week 8
Change in BMI
Time Frame: pre-intervention and Week 8
BMI (kg/m²)
pre-intervention and Week 8
Incidence of adverse events (AEs/SAEs)
Time Frame: Baseline (Week 0) through Week 8
Number and severity of adverse and serious adverse events recorded during the study.
Baseline (Week 0) through Week 8
Tolerability of the nutraceutical intervention
Time Frame: Baseline (Week 0) through Week 8
Assessment of subject-reported tolerability throughout the study.
Baseline (Week 0) through Week 8
Participant compliance to study intervention
Time Frame: Baseline (Week 0) through Week 8
Compliance assessed based on participant Compliance Diary
Baseline (Week 0) through Week 8
Change in complete blood count
Time Frame: Pre intervention and week 8
Complete blood count parameters like RBC, WBC count
Pre intervention and week 8
Change in Renal function test
Time Frame: Pre intervention and week 8
Renal function test parameters include Serum Bilirubin - Total,Serum Total Protein,Serum Bilirubin - Direct
Pre intervention and week 8
Change in Thyroid profile
Time Frame: pre intervention and week 8
Thyroid profile Parameters Include TSH ,T3.T4
pre intervention and week 8
Change in Lipid Profile
Time Frame: Pre intervention and Week 8
Lipid Profile Parameters Include Cholesterol Level, serum Triglycerides,HDL Cholesterol, LDL cholesterol
Pre intervention and Week 8
Change in Electrolytes
Time Frame: Pre Intervention and Week 8
Electrolytes parameters include Sodium,Potassium,Chlorides
Pre Intervention and Week 8
Change in Serum concentration of MDA marker
Time Frame: Pre-intervention and Week 8
MDA Marker
Pre-intervention and Week 8
Change in Serum concentration of SOD Marker
Time Frame: Pre-Intervention and Week 8
SOD Marker
Pre-Intervention and Week 8
Change in Serum Concentration of NAD+ levels
Time Frame: Pre-intervention and Week 8
NAD+ Marker
Pre-intervention and Week 8
Change in serum concentration of hs-CRP
Time Frame: Pre-intervention and week 8
hs-CRP Level
Pre-intervention and week 8
change in Serum concentration of TNF- alpha
Time Frame: Pre-intervention and Week 8
TNF-alpha Level
Pre-intervention and Week 8
Change in serum concentration of IL-6
Time Frame: Pre-intervention and Week 8
IL-6 Level
Pre-intervention and Week 8
Change in level of CD4/CD8 Ratio
Time Frame: Pre-intervention and Week 8
CD4/CD8 Ratio
Pre-intervention and Week 8
Change in CD45
Time Frame: Pre-intervention and Week 8
CD45 levels
Pre-intervention and Week 8
Change in CD3
Time Frame: Pre-intervention and Week 8
CD3 Levels
Pre-intervention and Week 8
Change in CD8
Time Frame: Pre-intervention and Week 8
CD8 Level
Pre-intervention and Week 8
Change in T cells
Time Frame: Pre-intervention and Week 8
T cells Levels
Pre-intervention and Week 8
Change in B cells
Time Frame: pre-intervention and Week 8
B cells levels
pre-intervention and Week 8
Change in NK cells
Time Frame: Pre-intervention and Week 8
NK cells Levels
Pre-intervention and Week 8
Change in lymphocyte/neutrophil ratio
Time Frame: Pre-intervention and Week 8
lymphocyte/neutrophil ratio
Pre-intervention and Week 8
Change in CD4
Time Frame: Pre-intervention and Week 8
CD4 levels
Pre-intervention and Week 8
Change in Liver Function test
Time Frame: Pre-intervention and Week 8
Liver Function test include serum Creatinine , Serum Urea, Serum uric Acid
Pre-intervention and Week 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
GPLIFE HEALTHCARE PRIVATE LIMITED

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 24, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 31, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 2, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 10, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 10, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 16, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 16, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 10, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Conditions

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Locations

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