Age-related Functional DeclinePhase 4NCT07534878
Health Benefits of Nutraceutical Supplementation in Older Adults.
A Phase 4 study testing Powder containing whey isolate and herbal extracts (30g sachet) in people with Age-related Functional Decline and Mild Cognitive Impairment, run by GPLIFE HEALTHCARE PRIVATE LIMITED at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Age-related Functional Decline, Mild Cognitive Impairment
- What is being tested?
- Powder containing whey isolate and herbal extracts (30g sachet)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteIndia
- Study dates
- 24 Dec 2025to 2 Mar 2026
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Being tested
- Powder containing whey isolate and herbal extracts (30g sachet)
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Powder containing whey isolate and herbal extracts (30g sachet) | Experimental | Not described Receives: Drug: Powder containing whey isolate and herbal extracts (30g sachet) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: pre-intervention and Week 8
Secondary outcomes (29)
1-RM strength test (knee extension)
Maximum weight (kg) lifted using leg press equipment to assess muscle strength
Measured: pre-intervention and Week 8
DXA scan
Muscleb volume will be measured using Dual-energy X-ray Absorptiometry (DXA)
Measured: 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
Measured: pre-intervention and Week 8
Cognitive biomarker levels (p-tau181)
Serum levels of phosphorylated tau (p-tau181) measured as a biomarker of cognitive function.
Measured: pre-intervention and Week 8
Change in BMI
BMI (kg/m²)
Measured: pre-intervention and Week 8
Incidence of adverse events (AEs/SAEs)
Number and severity of adverse and serious adverse events recorded during the study.
Measured: Baseline (Week 0) through Week 8
Tolerability of the nutraceutical intervention
Assessment of subject-reported tolerability throughout the study.
Measured: Baseline (Week 0) through Week 8
Participant compliance to study intervention
Compliance assessed based on participant Compliance Diary
Measured: Baseline (Week 0) through Week 8
Change in complete blood count
Complete blood count parameters like RBC, WBC count
Measured: Pre intervention and week 8
Change in Renal function test
Renal function test parameters include Serum Bilirubin - Total,Serum Total Protein,Serum Bilirubin - Direct
Measured: Pre intervention and week 8
Change in Thyroid profile
Thyroid profile Parameters Include TSH ,T3.T4
Measured: pre intervention and week 8
Change in Lipid Profile
Lipid Profile Parameters Include Cholesterol Level, serum Triglycerides,HDL Cholesterol, LDL cholesterol
Measured: Pre intervention and Week 8
Change in Electrolytes
Electrolytes parameters include Sodium,Potassium,Chlorides
Measured: Pre Intervention and Week 8
Change in Serum concentration of MDA marker
MDA Marker
Measured: Pre-intervention and Week 8
Change in Serum concentration of SOD Marker
SOD Marker
Measured: Pre-Intervention and Week 8
Change in Serum Concentration of NAD+ levels
NAD+ Marker
Measured: Pre-intervention and Week 8
Change in serum concentration of hs-CRP
hs-CRP Level
Measured: Pre-intervention and week 8
change in Serum concentration of TNF- alpha
TNF-alpha Level
Measured: Pre-intervention and Week 8
Change in serum concentration of IL-6
IL-6 Level
Measured: Pre-intervention and Week 8
Change in level of CD4/CD8 Ratio
CD4/CD8 Ratio
Measured: Pre-intervention and Week 8
Change in CD45
CD45 levels
Measured: Pre-intervention and Week 8
Change in CD3
CD3 Levels
Measured: Pre-intervention and Week 8
Change in CD8
CD8 Level
Measured: Pre-intervention and Week 8
Change in T cells
T cells Levels
Measured: Pre-intervention and Week 8
Change in B cells
B cells levels
Measured: pre-intervention and Week 8
Change in NK cells
NK cells Levels
Measured: Pre-intervention and Week 8
Change in lymphocyte/neutrophil ratio
lymphocyte/neutrophil ratio
Measured: Pre-intervention and Week 8
Change in CD4
CD4 levels
Measured: Pre-intervention and Week 8
Change in Liver Function test
Liver Function test include serum Creatinine , Serum Urea, Serum uric Acid
Measured: Pre-intervention and Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2026
- Study start24 Dec 2025
- Primary completion31 Jan 2026
- Study completion2 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Age-related Functional DeclineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- GPLIFE HEALTHCARE PRIVATE LIMITED
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07534878
- Sponsor's protocol ID
- GP/CT/25-26/001
- Status last verified
- Apr 2026
- First submitted
- 10 Mar 2026
- Last updated
- 16 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT07534878
- Acronym / sponsor ID
- GP/CT/25-26/001
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- GPLIFE HEALTHCARE PRIVATE LIMITEDIndustry (pharma, biotech, devices)
- Study start
- 24 Dec 2025 (actual)
- Primary completion
- 31 Jan 2026 (actual)
- Study completion
- 2 Mar 2026 (actual)
- First posted
- 16 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Powder containing whey isolate and herbal extracts (30g sachet) | Experimental | Drug: Powder containing whey isolate and herbal extracts (30g sachet) |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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)
- Intrinsic Capacity score showing mild to moderate decline
Key exclusion criteria (16 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Drug | Powder containing whey isolate and herbal extracts (30g sachet) |
Primary outcome
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.
29 secondary outcomes
1-RM strength test (knee extension)
Time frame: pre-intervention and Week 8
DXA scan
Time frame: pre-intervention and Week 8.
Cognitive performance assessed using NIH Toolbox Fluid Composite Score
Time frame: pre-intervention and Week 8
Cognitive biomarker levels (p-tau181)
Time frame: pre-intervention and Week 8
Change in BMI
Time frame: pre-intervention and Week 8
Incidence of adverse events (AEs/SAEs)
Time frame: Baseline (Week 0) through Week 8
Tolerability of the nutraceutical intervention
Time frame: Baseline (Week 0) through Week 8
Participant compliance to study intervention
Time frame: Baseline (Week 0) through Week 8
Change in complete blood count
Time frame: Pre intervention and week 8
Change in Renal function test
Time frame: Pre intervention and week 8
Change in Thyroid profile
Time frame: pre intervention and week 8
Change in Lipid Profile
Time frame: Pre intervention and Week 8
Change in Electrolytes
Time frame: Pre Intervention and Week 8
Change in Serum concentration of MDA marker
Time frame: Pre-intervention and Week 8
Change in Serum concentration of SOD Marker
Time frame: Pre-Intervention and Week 8
Change in Serum Concentration of NAD+ levels
Time frame: Pre-intervention and Week 8
Change in serum concentration of hs-CRP
Time frame: Pre-intervention and week 8
change in Serum concentration of TNF- alpha
Time frame: Pre-intervention and Week 8
Change in serum concentration of IL-6
Time frame: Pre-intervention and Week 8
Change in level of CD4/CD8 Ratio
Time frame: Pre-intervention and Week 8
Change in CD45
Time frame: Pre-intervention and Week 8
Change in CD3
Time frame: Pre-intervention and Week 8
Change in CD8
Time frame: Pre-intervention and Week 8
Change in T cells
Time frame: Pre-intervention and Week 8
Change in B cells
Time frame: pre-intervention and Week 8
Change in NK cells
Time frame: Pre-intervention and Week 8
Change in lymphocyte/neutrophil ratio
Time frame: Pre-intervention and Week 8
Change in CD4
Time frame: Pre-intervention and Week 8
Change in Liver Function test
Time frame: Pre-intervention and Week 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Powder containing whey isolate and herbal extracts (30g sachet) in people with Age-related Functional Decline and Mild Cognitive Impairment, run by GPLIFE HEALTHCARE PRIVATE LIMITED at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6-minute walk test (time frame: pre-intervention and Week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2026.