None listed
Conditions
Interventions
Intervention1: Powder containing whey isolate and herbal extracts (30g sachet): Mix with water and consume twice daily before meals.
Control Intervention1: NOT Applicable: -
Sponsors
GPLIFE HEALTHCARE PRIVATE LIMITED
Dr Chetan Savaliya
Eligibility
Inclusion criteria
Inclusion criteria: 1.Participants with- i)Generally good health with life expectance greater than equal to 5 years. ii)Male and female participants aged between 50 to 80 years having a BMI between 25 to 35 kg per meter Square. iii)Health not severely compromised that is no life threatening illness or disability. 2.Participants with- i)Intrinsic Capacity score showing mild to moderate decline and ii)Short Physical Performance Battery SPPB score between 9 to 11 and iii)Montreal Cognitive Assessment (MoCA) greater than 20 and less than equal to 25. 3.Participants with or without comorbidity. If comorbidity is present, it should be on a stable regimen that is same drug and same dose for at least 12 weeks before the screening visit. 4.Participants are able and willing to provide written informed consent, comply with the study protocol requirements, and can read and write in English.
Exclusion criteria
Exclusion criteria: 1.Severe or uncontrolled chronic disease osteoarthritis, advanced cardiovascular disease, kidney failure, uncontrolled diabetes, severe COPD, terminal cancer. 2.Physical disability requiring a walker or wheelchair. 3.Diagnosed dementia or cognitive impairment preventing protocol compliance. 4.Acute infection or illness within 3 months before enrollment. 5.Unstable medical conditions example recent MI, unstable angina, uncontrolled hypertension. 6.Major surgery in the past 6 months or planned during study. 7.Severe psychiatric disorders unless well controlled. 8.Substance abuse within past 6 months. 9.Participation in another clinical trial within the last 6 months. 10.Known allergy to any component of the nutraceutical kit. 11.Participants with sedentary lifestyles are not able or not advised to undergo the resistance training as per protocol. 12.Any clinically relevant macro or micro-nutrient deficiency as per investigator discretion. 13.Pregnant women, lactating women, women of child bearing potential not following adequate contraceptive measures, women who were found positive for urine pregnancy test. 14.Participants who are currently taking any herbal products, nutraceuticals, Ayurvedic formulations, dietary supplements, or vitamin or mineral supplements and are unwilling to discontinue their use for the duration of the study. 15.According to the investigator, any other illness or abnormal laboratory investigations would interfere directly with the study results or jeopardize the participants health.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Evaluate the impact of the combination nutraceutical kit on muscle function, including strength, endurance, and muscle mass. 2.Assess effects on cognitive performance, including executive function, memory, and processing speed. 3.Evaluate immune resilience and inflammation modulation through relevant immune biomarkers and immune cell measurements. Timepoint: 1.At Screening And day 60. 2.At Screening And day 60. 3.At Screening And day 60. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Evaluation of longevity biomarkers and Putative Energy markers. 2.Assessment of anthropometric parameters,hematological,biochemical investigation. 3.Adverse events profile 4.Compliance and tolerability of the investigational product. Timepoint: 1.At Screening And Day 60. 2.At Screening And Day 60. 3.from baseline to end of the study. 4.from baseline to end of the study. | — |
Countries
India
Contacts
Public ContactDr Shridhar Pandya
GPLIFE HEALTHCARE PRIVATE LIMITED
Outcome results
None listed