Lionheart Health, Inc. announced that enrollment is beginning for its Lionheart Klotho-Up Study, a longitudinal program designed to assess whether a structured wellness and bioelectric intervention program may help support key markers of healthy aging. The study focuses on the Klotho protein, widely recognized as an important longevity-associated protein linked to multiple aspects of healthy aging, including muscle function, brain health, vascular and metabolic health, inflammation balance, and overall healthy aging biology.
The study is built around two core required program elements: daily Klotho-favoring meals, supplements, and beverages designed to support a biologically favorable environment, and BodStim Klotho-enhancing exercise performed two or three times per week for one hour per session. Participants may also choose from optional supportive therapies, which may include hyperbaric oxygen therapy, red light therapy, cold therapy, pulsed electromagnetic field therapy, organ-targeted bioelectric stimulation, and other wellness-supportive interventions depending on availability, candidacy, and site offerings.
Howard Leonhardt, Executive Chairman and co-CEO of Lionheart Health, stated the company's goal is to make a Klotho-supportive lifestyle and bioelectric wellness program more structured, measurable, and accessible. He emphasized that many people want a guided program with objective testing to track whether their efforts, including technological interventions such as bioelectric controlled protein expressions, are improving meaningful indicators of health over time.
All participants must complete a formal informed patient consent process and agree to required baseline and one-year follow-up assessments. Required core assessments cover muscle health, brain health, and immune health. Muscle health assessments include grip strength, gait speed, a six-minute walk test, and muscle mass assessment. Brain health assessments involve standardized cognitive testing, memory testing, and mood assessment. Immune health assessments include gut intelligence testing and various immune and wellness-related biomarkers.
Additionally, all participants must complete a 461 blood biomarker panel at baseline and again at one year. Participants may elect to add biomarker testing at three months and six months, and in some cases an additional test at approximately four weeks may be recommended to help optimize supplements and program adherence. An AI-enhanced MRI through https://www.CoreViva.com will also be available on an optional basis for participants seeking deeper body composition and imaging-based insights.
For selected candidates at certain outside the United States affiliated sites, biologic therapies may also be available. These therapies would require a separate, higher-risk informed patient consent and would only be offered where legally permissible, medically appropriate, and under the oversight of the applicable treating clinicians and site protocols.
Enrollment is opening on a limited basis for qualified participants at licensed clinic locations. This is a subsidized paid registry study. Patients will pay $12.99 a day for health fresh Klotho-favoring meals delivered to their home daily or can choose to shop themselves following recipes sent to save costs. If patients make their own meals, they need to take a photo to upload to the study database daily. The BodStim EMS suit can be leased for one year with an $890 down payment and monthly payments of $188. The 461 biomarker test is $800 each for non-members and $463 for members.
The study sponsor Lionheart Health, Inc. will cover all muscle, brain, and immunity health test assessments at baseline and one year. If a patient selects to add voluntary testing at three months and six months, they will pay cost to cost for those extra tests. Optional AI-enhanced MRI scans will also be covered by patients.
This study supports Lionheart Health's participation in XPRIZE Healthspan, where Lionheart Health Inc. was named a Top 40 Milestone 1 awardee semi-finalist from more than 600 registered teams worldwide, reflecting the strength of its proposed therapeutic approach, preliminary data, and clinical testing strategy. The announcement clarifies that the Lionheart Klotho-Up Study is intended for research, wellness, and health optimization purposes, and participation requires informed consent.
