None listed
Conditions
Brief summary
Ageing is associated with declines in cognition, immune competence, and physiological performance, which contribute to reduced health span and quality of life. CX-50 may contain bioactive compounds (exosomes) hypothesised to modulate immune and metabolic pathways relevant to ageing. Exosomes represent a promising target for health span extension given their favourable safety profile and accessibility. This Phase 1 trial is being conducted as part of the XPRIZE Healthspan Semi-Finals to assess safety and feasibility in a controlled environment, in preparation for the competition Finals.
Interventions
The intervention, CX-50, is a nutraceutical of extracellular vesicles (EVs) derived from food-grade bovine adipose tissue. A freeze-dried powder form of the product will be taken orally at a rate of 80 grams each morning, mixed with 250 mls of milk or water. The intervention will be taken once a day for 6 weeks (42 days).
Participants will be given their first dose at the site clinic by the investigator or designee, under medical supervision. Participants will self-administer subsequent doses a
The intervention, CX-50, is a nutraceutical of extracellular vesicles (EVs) derived from food-grade bovine adipose tissue. A freeze-dried powder form of the product will be taken orally at a rate of 80 grams each morning, mixed with 250 mls of milk or water. The intervention will be taken once a day for 6 weeks (42 days). Participants will be given their first dose at the site clinic by the investigator or designee, under medical supervision. Participants will self-administer subsequent doses at home. Compliance with study intervention will be assessed at the Follow-up visit, after week 6 by verbally asking if participants missed any doses. Participants will also be provided with a diary in which they can record any missed doses. The diary will be returned to the site at the follow-up visit.
The intervention, CX-50, is a food grade product for oral consumption containing extracellular vesicles (EVs), primarily exosomes, derived from young bovine adipose tissue. A freeze-dried powder form of the product will be taken orally at a rate of 80 grams each morning, mixed with 250 ml of water. The intervention will be taken once a day for 6 weeks (42 days).
Participants will be given their first dose at the site clinic by the investigator or designee, under medical supervision. Participant
The intervention, CX-50, is a food grade product for oral consumption containing extracellular vesicles (EVs), primarily exosomes, derived from young bovine adipose tissue. A freeze-dried powder form of the product will be taken orally at a rate of 80 grams each morning, mixed with 250 ml of water. The intervention will be taken once a day for 6 weeks (42 days). Participants will be given their first dose at the site clinic by the investigator or designee, under medical supervision. Participants will self-administer subsequent doses at home. Compliance with study intervention will be assessed at the Follow-up visit, after week 6 by verbally asking if participants missed any doses. Participants will also be provided a Participant Diary to record any missed doses. The diary will be returned to the site at the Follow-up visit.
Sponsors
EXOMED
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
50 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
1. In good health, or with stable chronic medical conditions (e.g., hypertension, diabetes) with no change in medication during the previous 4 weeks, and are well controlled in the judgment of the Investigator. 2. Willing and able to comply with study procedures, assessments, and visit schedules for the duration of the trial. 3. If of childbearing potential, willing to use an acceptable method of contraception from the time of consent until 5 days after the last dose of study intervention. 4. Willing and able to provide written informed consent prior to any study-specific procedures. 5. Adequate English language proficiency to understand study requirements and complete assessments (cognitive, physiological, and self-reported).
Exclusion criteria
1. Known history of allergy, hypersensitivity, or intolerance to dietary or bovine products. 2. 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). 3. Chronic medical condition that has required a change in medication in the previous 4 weeks. 4. Active infection requiring systemic antimicrobial therapy within 14 days prior to baseline. 5. 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. 6. History of immunodeficiency or current use of systemic immunosuppressive therapy. 7. Participation in another interventional clinical study within 30 days prior to baseline. 8. Previous participation in any other XPRIZE Healthspan semi-finals study. 9. Planned major surgery or hospitalisation during the study period. 10. Current alcohol or substance misuse that, in the Investigator’s judgment, may interfere with compliance or safety. 11. Any condition associated with malabsorption or significant gastrointestinal disease likely to impair oral absorption of the investigational product. 12. Currently pregnant or breastfeeding. 13. Any other reason which, in the Investigator’s judgment, makes the participant unsuitable for study participation.
Outcome results
None listed