Bioavailability in healthy participants Nutritional, Metabolic, Endocrine
Conditions
Interventions
Current interventions as of 28/01/2026:
Randomisation will be conducted using the software available at www.sealedenvelope.com, by someone not involved in the conduct of the trial. The randomisation
Sponsors
Wild Nutrition Ltd
RDC Global
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Adults =18 years 2. Generally healthy 3. Body mass index (BMI) 18.5-34.9 kg/m² 4. Able to provide informed consent 5. Agree to not participate in another clinical trial while enrolled in this trial 6. Agree not to change current diet and/or exercise frequency or intensity during entire study period 7. Participant's ability to participate fully and comply with demands of the study including attendance at all scheduled blood collection time points 8. Able to attend the clinic on all required days 9. Females of childbearing potential will be required to have a negative pregnancy test on day of study
Exclusion criteria
Exclusion criteria: 1. Have a serious illness e.g. mood disorders such as depression, anxiety or bipolar disorder, neurological disorders such as MS, kidney disease, liver disease or heart conditions 2. Have an unstable illness e.g. diabetes and thyroid gland dysfunction 3. Current malignancy (excluding basal cell carcinoma) or chemotherapy or radiotherapy treatment for malignancy within the previous 2 years 4. Currently taking any long-term prescription medication (excluding contraceptive pill) (e.g., coumadin [warfarin], heparin, dalteparin, enoxaparin or other anticoagulation therapy including low dose aspirin) 5. Significant change in diet in the past 1 month (e.g., removal of a food group or calorie restriction) 6. Active smokers, nicotine use or drug (prescription or illegal substances) abuse 7. Chronic past and/or current alcohol use (>21 alcoholic drinks week) 8. Pregnant or lactating women 9. Allergic to any of the ingredients in either formulation 10. Participants who are currently participating in any other clinical trial. 11. Any condition which in the opinion of the investigator makes the participant unsuitable for inclusion 12. Regular use within the past 4 weeks of supplements containing the compound being tested (magnesium for Arm 1 and Vitamin B6 for Arm 2)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Group 1 (Magnesium): plasma uptake of Magnesium over 24 hours (AUC) measured using colourimetric assay via a clinical chemistry analyser from baseline to 24 hours 2. Group 2 (Vitamin B6): plasma uptake of Vitamin B6 over 6 hours (AUC) measured using LC-MS-MS from baseline to 24hours | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline to the end of the study period (24 hours) in: 1. Tmax: This is calculated from the plasma values analysed in the primary outcome from baseline to 24hours. 2. Cmax This is calculated from the plasma values analysed in the primary outcome from baseline to 24hours. 3. Participant demographics (age, gender) will be collected at screening 4. Individual absorption data for each participant. This will be measured as per the measurements in the primary outcomes from baseline to 24hours. 5. Evaluate tolerability, including gastrointestinal tract tolerance. This will be measured using a Gastrointestinal Tolerance Questionnaire and reported Adverse Events from Baseline to 24 hours. 6. Non-inferiority/equivalence comparison of the formulations. This is a comparison of AUC for each group as calculated from the primary outcome measures from baseline to 24hours. 7. Safety via AE monitoring from baseline to 24 hours. | — |
Countries
Australia
Contacts
Public ContactPippa Ebelt
Outcome results
None listed