Health Benefits of Nutraceutical Supplementation in Older Adults.

GPLIFE HEALTHCARE PRIVATE LIMITED23 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Interventions

Eligibility

Sex: ALLMin age: 50 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: pre-intervention and Week 8

Secondary Outcomes

1-RM strength test (knee extension)

Maximum weight (kg) lifted using leg press equipment to assess muscle strength

Time frame: pre-intervention and Week 8

DXA scan

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

Time frame: 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

Time frame: pre-intervention and Week 8

Cognitive biomarker levels (p-tau181)

Serum levels of phosphorylated tau (p-tau181) measured as a biomarker of cognitive function.

Time frame: pre-intervention and Week 8

Change in BMI

BMI (kg/m²)

Time frame: pre-intervention and Week 8

Incidence of adverse events (AEs/SAEs)

Number and severity of adverse and serious adverse events recorded during the study.

Time frame: Baseline (Week 0) through Week 8

Tolerability of the nutraceutical intervention

Assessment of subject-reported tolerability throughout the study.

Time frame: Baseline (Week 0) through Week 8

Participant compliance to study intervention

Compliance assessed based on participant Compliance Diary

Time frame: Baseline (Week 0) through Week 8

Change in complete blood count

Complete blood count parameters like RBC, WBC count

Time frame: Pre intervention and week 8

Change in Renal function test

Renal function test parameters include Serum Bilirubin - Total,Serum Total Protein,Serum Bilirubin - Direct

Time frame: Pre intervention and week 8

Change in Thyroid profile

Thyroid profile Parameters Include TSH ,T3.T4

Time frame: pre intervention and week 8

Change in Lipid Profile

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

Time frame: Pre intervention and Week 8

Change in Electrolytes

Electrolytes parameters include Sodium,Potassium,Chlorides

Time frame: Pre Intervention and Week 8

Change in Serum concentration of MDA marker

MDA Marker