Healthy Volunteer
Conditions
Keywords
absorption, vitamin D, omega-3
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTAquacelle® Omega 3
Participants will consume 1 capsule containing 315mg EPA and DHA
DIETARY_SUPPLEMENTComparator Omega 3
Participants will consume 1 capsule containing 315mg EPA and DHA
DIETARY_SUPPLEMENTPlexosome® Vitamin D3
Participants will have 1000IU vitamin D3 each day for 7 days
DIETARY_SUPPLEMENTComparator Vitamin D3
Participants will have 1000IU vitamin D3 each day for 7 days
DIETARY_SUPPLEMENTPlexosome® Vitamin D3 6 weeks
Participants will have 1000IU vitamin D3 each day for 6 weeks
COMBINATION_PRODUCTComparator Vitamin D3 6 weeks
Participants will have 1000IU vitamin D3 each day for 6 weeks
Sponsors
RDC Clinical Pty Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Double-blind omega-3 sub-study and a single-blind vitamin D3 sub-study, with blinded laboratory analysis and blinded statistical analysis
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Part A: Inclusion Criteria: * Adults 18 years and older * Generally healthy * BMI 18.5-29.9 kg/m2 * Able to provide informed consent * Agree to not participate in another clinical trial while enrolled in this trial * Agree not to change current diet and/or exercise frequency or intensity during entire study period * Participant's ability to participate fully and comply with demands of the study including attendance at all scheduled blood collection time points
Exclusion criteria
* 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 * Have an unstable illness e.g. diabetes and thyroid gland dysfunction * Current malignancy (excluding Basal Cell Carcinoma) or chemotherapy or radiotherapy treatment for malignancy within the previous 2 years * Significant change in diet in the past 1-month (e.g., removal of a food group or calorie restriction) * Active smokers, nicotine use or drug (prescription or illegal substances) abuse * Chronic past and/or current alcohol use (\>21 alcoholic drinks week) * Pregnant or lactating women * Allergic to any of the ingredients in enhanced or standard formula * Participants who are currently participating in any other clinical trial or who have participated in any other clinical trial during the past 1 month (excluding RDC Clinical trials) * Any condition which in the opinion of the investigator makes the participant unsuitable for inclusion * Regular use within the past 4 weeks of supplements containing the trial product Part B: The above criteria apply, plus baseline serum 25(OH)D \<20.0 ng/mL (\<50.0 nm/L)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Part A: serum/plasma absorption (AUC) of the trial product t0-t168 (vitamin D3) | Baseline to day 7 | Baseline-corrected values in serum/plasma absorption (AUC) of the trial product t0-t168 (vitamin D3) |
| Part A: serum/plasma absorption (AUC) of the trial product t0-t24 (omega-3) | Baseline to day 2 | Baseline-corrected values in serum/plasma absorption (AUC) of the trial product t0-t24 (omega-3) |
| Part B: Baseline-corrected serum 25(OH)D AUC (0-6 weeks) | Baseline to 6 weeks | Baseline-corrected serum 25(OH)D AUC (0-6 weeks) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Part A: Serum/plasma absorption (AUC) of the trial product t0-t8 (vitamin D3) | Baseline to 8 hours | Serum/plasma absorption (AUC) of the trial product t0-t8 (vitamin D3) |
| Part A: serum/plasma absorption (AUC) of the trial product t0-t24 (vitamin D3) | Baseline to day 2 | serum/plasma absorption (AUC) of the trial product t0-t24 (vitamin D3) |
| Part A: Serum/plasma absorption (AUC) of the trial product t0-t48 (vitamin D3) | Baseline to day 3 | Serum/plasma absorption (AUC) of the trial product t0-t48 (vitamin D3) |
| Part A: Serum/plasma absorption (AUC) of the trial product t0-t10 (omega-3) | Baseline to 10hours | Serum/plasma absorption (AUC) of the trial product t0-t10 (omega-3) |
| Part A: Change and absolute Tmax (vitamin D) | Baseline to day 7 | Change and absolute Tmax |
| Part A: Change and absolute Cmax (vitamin D) | Baseline to day 7 | Change and absolute Cmax |
| Part A: Change and absolute Tmax (omega-3) | Baseline to day 2 | Change and absolute Tmax |
| Part A: Change and absolute Cmax (omega-3) | Baseline to day 2 | Change and absolute Cmax |
| Part A: Participant demographics | Baseline | Participant demographics |
| Part A: Tolerability | Baseline to day 7 | Tolerability |
| Part A: Safety via AE monitoring | Baseline to day 7 | Safety via AE monitoring |
| Part B: Change from baseline at week 6, standard vs enhanced formulation | Baseline to week 6 | Change from baseline at week 6, standard vs enhanced formulation |
| Part B: Weekly 25(OH)D change | Baseline to week 6 | Weekly 25(OH)D change |
| Part B: Weekly cholecalciferol change | Baseline to week 6 | Weekly cholecalciferol change |
| Part B: Demographics | Baseline | Demographics |
| Part B: Tolerability | Baseline to week 6 | Tolerability |
| Part B: Safety (E/LFT) | Baseline to week 6 | Safety (E/LFT) |
Countries
Australia
Contacts
CONTACTDavid Briskey
PRINCIPAL_INVESTIGATORDavid Briskey
RDC Clinical
Outcome results
None listed