Pharmacokinetics
Conditions
Brief summary
A small cross-over trial on 3 different doses of liposomal vitamin C, comparing vitamin C uptake and downstream effects when 24 people consume 1, 2, and 5 grams on different test days, compared to placebo.
Detailed description
A randomized, cross-over study design will be used to evaluate the effects of consumption of 4 different doses of liposomal vitamin C (0, 1, 2, and 5 grams). The study is of 5 weeks' duration, with evaluation of a different dose at each of week 1, week 3 and week 5 with a one week washout between each dose.
Interventions
DIETARY_SUPPLEMENTLiposomal vitamin C, 1 gram
after a blood draw 1 gram of vitamin c will be consumed followed by 3 additional blood draws
DIETARY_SUPPLEMENTLiposomal vitamin C, 2 grams
after a blood draw 2 grams of vitamin c will be consumed followed by 3 additional blood draws
DIETARY_SUPPLEMENTLiposomal vitamin C, 5 grams
after a blood draw 5 grams of vitamin c will be consumed followed by 3 additional blood draws
DIETARY_SUPPLEMENTPlacebo
after a blood draw placebo will be consumed followed by 3 additional blood draws
Sponsors
Natural Immune Systems Inc
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Investigator)
Intervention model description
Randomized, placebo-controlled, single blind, cross-over trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* Adult people of either gender; * BMI between 18.0 and 34.9 (inclusive); * Willing to abstain from coffee, tea, and soft-drinks for at least one hour prior to a clinic visit; * Willing to abstain from alcohol for at least 12 hours prior to a clinic visit; * Willing to maintain a consistent habit of abstaining from exercising, tobacco use, and nutritional supplements on the morning of a study visit.
Exclusion criteria
* Cancer during past 12 months; * Chemotherapy during past 12 months; * Significant active uncontrolled illness (such as lymphoma, liver disease, kidney failure, heart failure). * Previous major surgery to stomach or intestines \[(absorption of test product may be altered) minor surgery is not a problem, including appendix and gallbladder removal\]; * Currently taking nutritional supplements judged by the study coordinator to negate or camouflage the effects of the test product; * Food allergies related to ingredients in test product; * Women who are pregnant, nursing, or trying to become pregnant.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of vitamin C levels | 6 hours | HPLC (High performance liquid chromatography) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of antioxidant status | 6 hours | FRAP (Ferric reducing antioxidant power) assay |
Other
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of downstream effects reflecting antioxidant protection | 6 hours | lipid peroxidation |
Countries
United States
Contacts
Primary ContactGitte Jensen, PhD
Outcome results
None listed