Evaluate leukocyte ascorbic acid (AA) accumulation kinetics in healthy adult males and females. Other
Conditions
Interventions
Participants will be randomized using the stratified randomization method based on age, gender and body weight. Participants will donate a fasting blood sample and then consume the assigned treatment
Sponsors
The Bountiful Company, a Nestlé Health Science Company
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Willingness to provide voluntary, written, informed consent to participate in the study 2. Healthy adults aged 18 - 60 years 3. Body Mass Index (BMI) between 18 - 30 kg/m2 4. Non-smokers or have stopped smoking for more than one year 5. Willingness to consume a low-vitamin C diet during the study
Exclusion criteria
Exclusion criteria: 1. Pregnancy, breastfeeding, or wishing to become pregnant during the study (confirmed via a negative pregnancy test) 2. Prescription or over-the-counter (OTC) products known to interact with vitamin C within 72 hours of randomization and during the trial, such as aspirin, non-steroidal anti-inflammatory drugs (NSAIDs), aluminium-containing antacids and iron 3. Proton pump inhibitors (e.g., Prilosec, Nexium, Prevacid) within the past month 4. Multivitamins or other dietary supplements containing vitamin C within 7 days of randomization and during the trial 5. Diagnosed with type 1 or 2 diabetes 6. Gastroesophageal reflux disease within the past 3 months 7. History of significant gastrointestinal disease or a history of malabsorption, or any other condition which, in the Investigator's opinion, may adversely affect the participant's ability to complete the study or its measures or which pose a significant risk to the participant 8. Uncontrolled heart disease, hypertension, thyroid disease, cancer, neurological disease, or untreated psychotic or major depressive disorder that may limit their participation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome measure is to evaluate comparative leukocyte ascorbic acid (AA) accumulation kinetics following acute doses, of different amounts, from two sources of AA measured in blood samples using High-Performance Liquid Chromatography (HPLC) at baseline, 0, 1, 2, 4, 8, 24 and 32 hours post supplementation | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary outcome measure is to evaluate comparative leukocyte ascorbic acid (AA) accumulation kinetics, plasma AA accumulation kinetics, and neutrophil phagocytic function following acute doses, of different amounts, from two sources of AA measured in blood samples using imaging flow cytometry at baseline, 0, 1, 2, 4, 8, 24 and 32 hours post supplementation. | — |
Countries
United States of America
Contacts
Public ContactChristopher Rasmussen
Outcome results
None listed