Clinical Research
Klotho-Up Wellness Study
A 12-month, open-label, non-randomized interventional feasibility study evaluating a combined approach to increasing circulating Klotho and supporting healthspan.
- Design
- 12-month, open-label, non-randomized interventional feasibility study
- Primary focus
- Muscle function, cognitive performance and immune health
- Oversight
- U.S. IRB approved core arm; separate IRB approval required in each outside-U.S. clinic country
Study arms
U.S. IRB approved
U.S. Core Arm
Participants receive a coordinated program consisting of:
- Bioelectric neuromuscular stimulation and enhanced exercise, generally two to three sessions weekly.
- A Klotho-promoting nutrition program.
- Daily supplements, including Rejuvant™, personalized SNIP Nutrition and Klotho-support supplements.
- Optional targeted bioelectric therapies addressing joint, sexual, skin, hair/scalp, gut, vision, hearing, bladder, kidney, blood pressure and inflammation health.
- U.S. IRB approval permits legally available research peptides, including Klotho peptides, with proper separate patient consent.
Requires separate IRB approval in each OUS clinic country
Outside-U.S. Advanced Arm
The optional international arm combines the core program with physician-directed advanced interventions:
- AAV gene therapy targeting Klotho, hTERT and Follistatin.
- A personalized peptide longevity stack, including Klotho peptides, administered alongside the bioelectric and lifestyle program.
- Optional Klotho and other exosomes, from pre-differentiated cells; U.S.-sourced preferred.
- Optional umbilical cord stem cells, encapsulated MSCs and Klotho-expressing stem cells.
- Additional safety monitoring appropriate to these investigational interventions, subject to applicable local regulatory and ethics requirements.
Assessments and outcomes
- Visit 1Baseline
- Visit 2~3 months
- Visit 3~6 months
- Visit 4~12 months
The assessment program includes an extensive biomarker panel, microbiome testing and imaging.
Primary measures
- Muscle strength
- Walking performance
- Muscle mass
- Cognition
- Memory
- Mood
- Immune and inflammatory markers
- Circulating Klotho
Secondary measures
- Vision
- Hearing
- Joint pain
- Sexual health
- Skin elasticity
- Hair density
- Sleep
- Stress
- Bladder health
- Exercise capacity