Evaluating absorption of investigational formulations against standard formulations in healthy volunteers Other
Conditions
Interventions
There are 3 arms in this study:
- Arm 1: Participants will receive a single dose of 1000mg standard vitamin C and 1000mg Rho Nutrition vitamin C. As this study is a cross-over the participants will r
Sponsors
Rho Nutrition
RDC Global
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: 1. Adults aged 18-50 years 2. BMI 18.5-30.0 kg/m² 3. Able to provide informed consent 4. Agree not to participate in another clinical trial while enrolled in this trial 5. Agree not to change current diet and/or exercise frequency or intensity during the entire study period 6. Females using a prescribed form of birth control (e.g. oral contraceptive) 7. Ability to participate fully and comply with the demands of the study, including attendance at all scheduled blood collection time points
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, gallbladder 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. Significant change in diet in the past 1 month (e.g. removal of a food group or calorie restriction) 5. Active smokers, nicotine use or drug (prescription or illegal substances) abuse 6. Chronic past and/or current alcohol use (>21 alcoholic drinks per week) 7. Pregnant or lactating women 8. Allergic to any of the ingredients in the enhanced or standard formula 9. 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) 10. Any condition which, in the opinion of the investigator, makes the participant unsuitable for inclusion 11. Currently taking Coumadin (warfarin), heparin, dalteparin, enoxaparin or other anticoagulation therapy including low-dose aspirin, or any other medicine or supplement that may interact with the study product 12. Regular use within the past 14 days of supplements containing the trial product 13. Have any condition that may interfere with the absorption, metabolism or excretion of the study product, e.g. Crohn's disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serum/plasma absorption (AUC) of Vitamin C t0-t24 measured using blood test at baseline and 24 hours;Serum/plasma absorption (AUC) of CoQ10 t0-t10 measured using blood test at baseline and 10 hours;Serum/plasma absorption (AUC) of Curcumin + Resveratrol t0-t24 measured using blood test at baseline and 24 hours | — |
Countries
Australia
Contacts
Public ContactDavid Briskey
Outcome results
None listed