Health Benefits of Nutraceutical Supplementation in Older Adults.

NCT07534878 | Completed Phase 4 DMC

• 1 other identifier: GP/CT/25-26/001
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Age-related Functional Decline; Mild Cognitive Impairment

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (29)

• 1-RM strength test (knee extension)

  pre-intervention and Week 8

• DXA scan

  pre-intervention and Week 8.

• Cognitive performance assessed using NIH Toolbox Fluid Composite Score

  pre-intervention and Week 8

• Cognitive biomarker levels (p-tau181)

  pre-intervention and Week 8

• Change in BMI

  pre-intervention and Week 8

Study Arms (1)

Powder containing whey isolate and herbal extracts (30g sachet)

EXPERIMENTAL

Drug: Powder containing whey isolate and herbal extracts (30g sachet)

Interventions

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.

Powder containing whey isolate and herbal extracts (30g sachet)

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• GPLIFE HEALTHCARE PRIVATE LIMITED: lead

Study Sites (1)

Gplife Healthcare Private Limited

Surat, Gujarat, 395010, India

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2026
• First Posted: April 16, 2026
• Study Start: December 24, 2025
• Primary Completion: January 31, 2026
• Study Completion: March 2, 2026
• Last Updated: April 16, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)