Bioavailability in healthy volunteers Other
Conditions
Interventions
In this study there will be two arms:
- Arm 1: Participants will be randomly allocated to receive a single dose of either Liposomal D3 + K2 (investigational product containing D3 = 4,000 IU, K2 = 620
Sponsors
Cymbiotika LLC
RDC Global
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: 1. Males and females 18-50 years (target at least 50% female participation) 2. Generally healthy with no acute or chronic diseases 3. BMI 18.5-30 kg/m² 4. Non-smokers or former smokers who have abstained for at least 6 months 5. Able to provide informed consent 6. Able to fast for 10 hours prior to study visits 7. Using contraception (if female and sexually active) 8. Able to attend all required study visits 9. Agree to not participate in another clinical trial while enrolled in this trial 10. Agree to maintain consistent dietary and exercise patterns during study period 11. Females of childbearing potential will be required to have a negative pregnancy test on day of study.
Exclusion criteria
Exclusion criteria: 1. BMI 30 kg/m² 2. History of cardiovascular disease, Type 2 diabetes, neurodegenerative disease, renal disease, metabolic syndrome, muscular dystrophy, or other acute/chronic diseases. 3. Gastrointestinal or absorption issues (IBD, IBS, Celiac disease, Crohn's disease, history of GI surgery, SIBO) 4. Use of statins, medications that inhibit absorption (fibrates, resins), medications affecting fat absorption (orlistat, cetilistat), medications impacting gut integrity (corticosteroids), anticoagulants (warfarin, heparin) or medications indicative of chronic conditions within past 3 months 5. Have a serious illness1 e.g. mood disorders such as depression, anxiety or bipolar disorder, neurological disorders such as MS, kidney disease, liver disease or cardiovascular disease 6. Have an unstable illness2 e.g. diabetes and thyroid gland dysfunction 7. Current malignancy (excluding Basal Cell Carcinoma) or chemotherapy or radiotherapy treatment for malignancy within the previous 2 years 8. Vegan or following an extreme diet that may significantly affect nutrient absorption (e.g., very low-fat diets 21 alcoholic drinks week) 12. Pregnancy, breastfeeding, or planning pregnancy during the study period 13. Unable to adhere to study protocol 14. Allergic to any of the ingredients in product formula 15. High-intensity athletic training (>10 hours structured exercise per week) that may affect metabolism 16. Participants who are currently participating in any other clinical trial or who have participated in any other clinical trial during the past 1 month 17. Any condition which in the opinion of the investigator makes the participant unsuitable for inclusion 18. Able to attend the clinic on all required days
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Plasma/serum uptake (AUC) of the relevant supplement (vitamin D3 and glutathione) taken over the trial period. Baseline to Day 2 (arm 2: Glutathione), Baseline to day 3 (arm 1: D3) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Maximum concentration (Cmax) 2. Time to maximum concentration (Tmax) 3. Individual absorption data for each subject 4. Tolerability assessment 5. Safety via adverse event monitoring 6. Non-inferiority/equivalence comparison between different formulations 7. Participant demographics and anthropometrics Secondary endpoints will be from Baseline to Day 2 (arm 2: Glutathione) or Baseline to day 3 (arm 1: D3) | — |
Countries
Australia
Contacts
Public ContactPippa Ebelt
Outcome results
None listed