Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 5:05 AM
Ignite Modification Date:
2025-12-25 @ 5:05 AM
NCT ID:
NCT06953518
Brief Summary:
This open-label pilot study includes adults aged 45 to 79 residing in the United States. The study will last 7 days. Participants will provide blood samples via an at-home finger-prick kit at baseline and day 7 and complete electronic surveys on health indicators at baseline, and days 3 and 7. All procedures are conducted remotely, with no in-person visits, to collect real-world evidence.
Detailed Description:
Objectives Within-group changes in outcomes will be compared from baseline to the end of the study period.
Primary Outcome Measures:
Biomarkers in blood, measured using the Olink Target 48 Cytokine panel:
Tumor Necrosis Factor (TNF) Interleukin-1 Beta (IL1B) Interleukin-8 (CXCL8) Vascular Endothelial Growth Factor A (VEGFA)
Secondary Outcome Measures:
Remaining biomarkers in the Olink Target 48 Cytokine panel 36-Item Short Form Health Survey (SF-36) Frailty Index for Elders (FIFE) Depression Anxiety Stress Scale-21 (DASS-21)
Side effect profile including:
Number, type, severity, causality, and outcome of adverse events or unanticipated problems
Symptoms of aging, assessed by:
Aging Male Symptom scale Aging Female Symptom scale
Participant Details:
Study Duration per Participant: 7 days Total Number of Participants: 40
Study:
NCT06953518
Study Brief:
Protocol Section:
NCT06953518