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Completed

NCT Number: NCT07534878

Health Benefits of Nutraceutical Supplementation 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.

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Key information

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Gplife Healthcare Private Limited

Surat, Gujarat, 395010, India

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. DXA scan

    Time frame: pre-intervention and Week 8.

    Muscleb volume will be measured using Dual-energy X-ray Absorptiometry (DXA)

  3. 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

  4. 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.

  5. Change in BMI

    Time frame: pre-intervention and Week 8

    BMI (kg/m²)

  6. 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.

  7. Tolerability of the nutraceutical intervention

    Time frame: Baseline (Week 0) through Week 8

    Assessment of subject-reported tolerability throughout the study.

  8. Participant compliance to study intervention

    Time frame: Baseline (Week 0) through Week 8

    Compliance assessed based on participant Compliance Diary

  9. Change in complete blood count

    Time frame: Pre intervention and week 8

    Complete blood count parameters like RBC, WBC count

  10. 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

  11. Change in Thyroid profile

    Time frame: pre intervention and week 8

    Thyroid profile Parameters Include TSH ,T3.T4

  12. Change in Lipid Profile

    Time frame: Pre intervention and Week 8

    Lipid Profile Parameters Include Cholesterol Level, serum Triglycerides,HDL Cholesterol, LDL cholesterol

  13. Change in Electrolytes

    Time frame: Pre Intervention and Week 8

    Electrolytes parameters include Sodium,Potassium,Chlorides

  14. Change in Serum concentration of MDA marker

    Time frame: Pre-intervention and Week 8

    MDA Marker

  15. Change in Serum concentration of SOD Marker

    Time frame: Pre-Intervention and Week 8

    SOD Marker

  16. Change in Serum Concentration of NAD+ levels

    Time frame: Pre-intervention and Week 8

    NAD+ Marker

  17. Change in serum concentration of hs-CRP

    Time frame: Pre-intervention and week 8

    hs-CRP Level

  18. change in Serum concentration of TNF- alpha

    Time frame: Pre-intervention and Week 8

    TNF-alpha Level

  19. Change in serum concentration of IL-6

    Time frame: Pre-intervention and Week 8

    IL-6 Level

  20. Change in level of CD4/CD8 Ratio

    Time frame: Pre-intervention and Week 8

    CD4/CD8 Ratio

  21. Change in CD45

    Time frame: Pre-intervention and Week 8

    CD45 levels

  22. Change in CD3

    Time frame: Pre-intervention and Week 8

    CD3 Levels

  23. Change in CD8

    Time frame: Pre-intervention and Week 8

    CD8 Level

  24. Change in T cells

    Time frame: Pre-intervention and Week 8

    T cells Levels

  25. Change in B cells

    Time frame: pre-intervention and Week 8

    B cells levels

  26. Change in NK cells

    Time frame: Pre-intervention and Week 8

    NK cells Levels

  27. Change in lymphocyte/neutrophil ratio

    Time frame: Pre-intervention and Week 8

    lymphocyte/neutrophil ratio

  28. Change in CD4

    Time frame: Pre-intervention and Week 8

    CD4 levels

  29. Change in Liver Function test

    Time frame: Pre-intervention and Week 8

    Liver Function test include serum Creatinine , Serum Urea, Serum uric Acid

Sponsors and collaborators

Lead sponsor

GPLIFE HEALTHCARE PRIVATE LIMITED

Industry

Registry information

Official study 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.

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 16, 2026
Registry last updated
Apr 16, 2026

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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