Research Evaluation of an Exosome-based Nutraceutical for Vitality and Immune function Given ORally: RE-ENVIGOR study

Exclusion Criteria13

• Known history of allergy, hypersensitivity, or intolerance to dietary or bovine products.
• Clinically significant medical condition that, in the opinion of the Investigator, would place the participant at undue risk or interfere with study assessments (e.g. uncontrolled diabetes, cardiovascular, hepatic, renal, neurological, or psychiatric disease).
• Chronic medical condition that has required a change in medication in the previous 4 weeks.
• Active infection requiring systemic antimicrobial therapy within 14 days prior to baseline.
• Use of systemic corticosteroids within 30 days prior to screening. Inhaled, topical, or intra-articular corticosteroids may be permitted if not expected to impact systemic immune function.
• History of immunodeficiency or current use of systemic immunosuppressive therapy.
• Participation in another interventional clinical study within 30 days prior to baseline.
• Previous participation in any other XPRIZE Healthspan semi-finals study.
• Planned major surgery or hospitalisation during the study period.
• Current alcohol or substance misuse that, in the Investigator’s judgment, may interfere with compliance or safety.
• Any condition associated with malabsorption or significant gastrointestinal disease likely to impair oral absorption of the investigational product.
• Currently pregnant or breastfeeding.
• Any other reason which, in the Investigator’s judgment, makes the participant unsuitable for study participation.