The goal of this interventional study is to compare the absorption of supplements with and without absorption enhancing technology in healthy volunteers. We will be testing vitamin D3 and omega 3 in both males and females 18 years and older. Part A will comprise of two arms receiving a single dose of omega-3 supplement, and two arms who will receive vitamin D3 supplement daily for 7 days. Part B comprises of two arms who will receive vitamin D3 supplement daily for 6 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Enrollment
160
Participants will consume 1 capsule containing 315mg EPA and DHA
Participants will consume 1 capsule containing 315mg EPA and DHA
Participants will have 1000IU vitamin D3 each day for 7 days
RDC Clinical
Fortitude Valley, Queensland, Australia
RECRUITINGPart A: serum/plasma absorption (AUC) of the trial product t0-t168 (vitamin D3)
Baseline-corrected values in serum/plasma absorption (AUC) of the trial product t0-t168 (vitamin D3)
Time frame: Baseline to day 7
Part A: serum/plasma absorption (AUC) of the trial product t0-t24 (omega-3)
Baseline-corrected values in serum/plasma absorption (AUC) of the trial product t0-t24 (omega-3)
Time frame: Baseline to day 2
Part B: Baseline-corrected serum 25(OH)D AUC (0-6 weeks)
Baseline-corrected serum 25(OH)D AUC (0-6 weeks)
Time frame: Baseline to 6 weeks
Part A: Serum/plasma absorption (AUC) of the trial product t0-t8 (vitamin D3)
Serum/plasma absorption (AUC) of the trial product t0-t8 (vitamin D3)
Time frame: Baseline to 8 hours
Part A: serum/plasma absorption (AUC) of the trial product t0-t24 (vitamin D3)
serum/plasma absorption (AUC) of the trial product t0-t24 (vitamin D3)
Time frame: Baseline to day 2
Part A: Serum/plasma absorption (AUC) of the trial product t0-t48 (vitamin D3)
Serum/plasma absorption (AUC) of the trial product t0-t48 (vitamin D3)
Time frame: Baseline to day 3
Part A: Serum/plasma absorption (AUC) of the trial product t0-t10 (omega-3)
Serum/plasma absorption (AUC) of the trial product t0-t10 (omega-3)
Time frame: Baseline to 10hours
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Participants will have 1000IU vitamin D3 each day for 7 days
Participants will have 1000IU vitamin D3 each day for 6 weeks
Participants will have 1000IU vitamin D3 each day for 6 weeks
Part A: Change and absolute Tmax (vitamin D)
Change and absolute Tmax
Time frame: Baseline to day 7
Part A: Change and absolute Cmax (vitamin D)
Change and absolute Cmax
Time frame: Baseline to day 7
Part A: Change and absolute Tmax (omega-3)
Change and absolute Tmax
Time frame: Baseline to day 2
Part A: Change and absolute Cmax (omega-3)
Change and absolute Cmax
Time frame: Baseline to day 2
Part A: Participant demographics
Participant demographics
Time frame: Baseline
Part A: Tolerability
Tolerability
Time frame: Baseline to day 7
Part A: Safety via AE monitoring
Safety via AE monitoring
Time frame: Baseline to day 7
Part B: Change from baseline at week 6, standard vs enhanced formulation
Change from baseline at week 6, standard vs enhanced formulation
Time frame: Baseline to week 6
Part B: Weekly 25(OH)D change
Weekly 25(OH)D change
Time frame: Baseline to week 6
Part B: Weekly cholecalciferol change
Weekly cholecalciferol change
Time frame: Baseline to week 6
Part B: Demographics
Demographics
Time frame: Baseline
Part B: Tolerability
Tolerability
Time frame: Baseline to week 6
Part B: Safety (E/LFT)
Safety (E/LFT)
Time frame: Baseline to week 6