The difference between Ester-C and ascorbic acid in adult women and men
| ISRCTN | ISRCTN49416083 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN49416083 |
- Submission date
- 27/04/2023
- Registration date
- 03/05/2023
- Last edited
- 03/07/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
Background and study aims
This study compares Ester-C® and ascorbic acid (AA) by analyzing their effects on leukocyte (white blood cell) and neutrophil (a type of white blood cell) function. Studies have shown that acute doses of 1000 mg of Ester-C® led to higher concentrations of AA in leukocytes for up to 24 hours compared to AA alone. Neutrophils are the most abundant white blood cells in the human body and require AA to protect them from oxidative damage. Studies have shown that low levels of vitamin C can impair neutrophil function, while supplementation can improve it. The researchers hypothesize that acute supplementation with Ester-C® will lead to better leukocyte and plasma AA levels and improved neutrophil phagocytic function compared to AA alone.
Who can participate?
Healthy male and female adults aged 18 to 60 years old
What does the study involve?
This study involves repeat blood draws after the ingestion of a low or high dose of either Ester-C (which provides AA) or AA by itself in hopes of evaluating comparative leukocyte AA accumulation kinetics. Moreover, to evaluate comparative leukocyte AA accumulation in the body, plasma AA accumulation kinetics, and neutrophil phagocytic function.
What are the possible benefits and risks of participating?
The study cannot promise any benefits to the participants. However, possible benefits include increased insight into their personal health. Possible risks of the study include a small amount of pain when the needle and/or catheter is inserted into the vein as well as some bleeding and bruising during the blood draws. The participant may also experience some dizziness, nausea, and/or faint if they are unaccustomed to having blood drawn. Risks that are possible but unlikely include infection, nerve damage and puncturing an artery instead of a vein. The treatments may cause possible nausea, vomiting, esophagitis, heartburn, abdominal cramps, gastrointestinal obstructions, diarrhea, fatigue, headache, insomnia and sleepiness. Although allergic reactions to vitamin C are rare, symptoms may include; itching or swelling in the face, lips or mouth, skin rashes, hives, asthma, sinus pressure, nasal congestion, shortness of breath, wheezing, sinus headaches, diarrhea, vomiting, nausea and abdominal pain. One of the risks of being in this study is that personal information could be lost or exposed. This is very unlikely to happen, and the researchers will do everything possible to ensure that private information is protected.
Where is the study run from?
The study is run through the Exercise & Sport Nutrition Laboratory (ESNL) at Texas A&M University (USA)
When is the study starting and how long is it expected to run for?
December 2020 to December 2022
Who is funding the study?
The Bountiful Company, a Nestlé Health Science Company (USA)
Who is the main contact?
Dr Richard Kreider, (Texas A&M University), rbkreider@tamu.edu
Contact information
Scientific
Texas A&M University
675 John Kimbrough Blvd
College Station
77843-4253
United States of America
| Phone | +1 9794581498 |
|---|---|
| rbkreider@tamu.edu |
Public
Texas A&M University
675 John Kimbrough Blvd
College Station
77843-4253
United States of America
| Phone | +1 9794581741 |
|---|---|
| crasmussen@tamu.edu |
Study information
| Study design | Single-centre randomized controlled crossover counterbalanced pharmacokinetic study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised cross over trial |
| Study setting(s) | Laboratory, University/medical school/dental school |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | A cross-over comparator study between Ester-C and ascorbic acid evaluating acute pharmacokinetics in adult women and men |
| Study objectives | We hypothesize that acute supplementation with Ester-C will elicit superior leukocyte and plasma ascorbic acid (AA) pharmacokinetics, and neutrophil phagocytic function in comparison to equimolar doses of vitamin C from AA. |
| Ethics approval(s) | Approved 26/04/2021, Texas A&M University Institutional Review Board (IRB), (Blocker Bldg 204C, 155 Ireland, College Station, Texas 77843-1186, USA; +1 979-458-4067; irb@tamu.edu), ref: IRB2021-0020, 119277 |
| Health condition(s) or problem(s) studied | Evaluate leukocyte ascorbic acid (AA) accumulation kinetics in healthy adult males and females. |
| Intervention | 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 of either 250 mg of Ester-C (providing 250 mg of ascorbic acid - AA) or 250 mg of AA if on the lower dose protocol or either 500 mg of Ester-C (providing 500 mg of AA) or 500 mg of AA if on the higher dose protocol. Follow-up blood samples will then be collected after 1, 2, 4, and 8 hours. Participants will then complete an adverse event questionnaire and an unblinding questionnaire. Participants will be given a low-vitamin C-containing standardized meal to consume after providing the 8-hour blood sample and before retiring for the night. The participants will return to the lab in a fasted condition the next morning for a 24-hour blood sample and be provided with a standardized breakfast. They will then finally donate a 32-hour post-ingestion blood sample. The participants will then be asked to observe a 7-28 day washout period (tested at the same time of menstrual cycle for women) and repeat the experiment with the alternative supplement. |
| Intervention type | Supplement |
| Primary outcome measure | 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 outcome measures | 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. |
| Overall study start date | 15/12/2020 |
| Completion date | 19/12/2022 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 120 |
| Total final enrolment | 95 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 27/04/2021 |
| Date of final enrolment | 27/10/2021 |
Locations
Countries of recruitment
- United States of America
Study participating centre
College Station
77843-4253
United States of America
Sponsor information
Industry
1041 US-202
Bridgewater
08807
United States of America
| Phone | +1 9083339100 |
|---|---|
| nhscusmedia@us.nestle.com | |
| Website | https://www.nestlehealthscience.us/ |
Funders
Funder type
Industry
Private sector organisation / For-profit companies (industry)
- Alternative name(s)
- Nestlé Health Science S.A.
- Location
- United States of America
Results and Publications
| Intention to publish date | 01/01/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Dr. Richard Kreider, rbkreider@tamu.edu. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 02/10/2024 | 03/07/2025 | Yes | No |
Editorial Notes
03/07/2025: Publication reference added.
02/05/2023: Trial's existence confirmed by Texas A&M University Institutional Review Board (USA).
