Nutrition, HealthyNCT06372171
Effects of Liposomal Encapsulation on Vitamin C Absorption and Metabolism
A study testing Satge 1 and Stage 2 in people with Nutrition, Healthy, run by National Yang Ming Chiao Tung University at 1 site in Taiwan.
Trial summary
Vitamin C is an important antioxidant in the human body and plays many important roles. It is currently known that vitamin C has the functions of treating scurvy, assisting in collagen synthesis, whitening, and increasing immunity. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Nutrition, Healthy
- What is being tested?
- Satge 1 and Stage 2
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteTaiwan
- Study dates
- Apr 2024to Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adults aged 20-60 years old, without heart, liver, kidney, endocrine or major organic diseases (patient report), and able to fully cooperate with the experiment.
Who cannot join
- Patients with renal insufficiency and dialysis
- Cancer patients
- Underweight (BMI≦17) or obese (BMI≧27)
- Those taking medications for chronic diseases
- Blood pressure systolic blood pressure ≧ 130 mmHg or diastolic blood pressure ≧ 85 mmHg
- Fasting blood glucose ≧ 100 mg/dL
Show all 13Show fewer
- Fasting triglycerides ≧ 150 mg/dL, total cholesterol ≧ 200 mg/dL
- Have a history of vitamin C allergy
- People suffering from mental illness
- Pregnant and breastfeeding women
- Patients with hemosiderosis
- Kidney stone patients
- People who take vitamin C for a long time should take supplements (at least 200 mg per day for more than one month)
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Yang Ming Chiao Tung University
Taipei, Beitou Dist., 112
Tze-Fang Wang, Ph.D., +886-2-28267907, tzefang@nycu.edu.tw
About this study
Vitamin C is an important antioxidant in the human body and plays many important roles. It is currently known that vitamin C has the functions of treating scurvy, assisting in collagen synthesis, whitening, and increasing immunity. Smokers, patients with cardiovascular disease, and patients with diabetes may have higher requirements for vitamins due to higher oxidative stress in the body. Liposome coating is a technology commonly used in food processing and medicine to protect active substances, increase absorption or slow release. Currently, vitamin C is commonly available on the market as an additive nutritional supplement in the form of powder packets, tablets, etc. The disadvantages are that vitamin C is relatively unstable, easily destroyed by gastric acid, and maintains blood concentration for a short time. Taking liposome microbial C has been Found to have the potential to increase bioavailability in the human body, it is expected that vitamin C coated with lecithin is relatively stable and can be stabilized in the small intestine without being damaged by gastric acid, while reducing the risk of gastrointestinal discomfort caused by the acidity of vitamin C. According to the revised seventh edition of the Reference Intake of Dietary Nutrients for Chinese People, the upper daily intake of vitamin C (tolerable upper intake levels, UL) for people aged 19 to 70 is 2,000 mg. According to literature, the absorption rate of vitamin C when consuming 30-180 mg per day is about 70-90%; when the daily intake exceeds 1000 mg, the absorption rate will drop to less than 50%. The dose of vitamin C used in this study is more than 1500 mg. The purpose is to explore whether the sustained-release characteristics of liposome coating technology can improve the absorption rate and achieve better bioavailability when consuming high-dose vitamin C powder. It is expected that through the egg The liposome vitamin C powder made of phospholipids increases its maintenance time in the blood, thereby increasing the supplementary effect of vitamin C powder and serving as another supplement option for vitamin C.
Read the detailed description
The trial is divided into two parts, the first part is "pre-trial screening" and the second part is "clinical trial".
This trial will first conduct the following tests to confirm that the subjects meet the inclusion and exclusion conditions before screening before they are eligible for the formal trial.
- General examination (height, weight, blood pressure)
- Blood biochemical index detection (fasting blood glucose, triglycerides, total cholesterol, Blood urea nitrogen, Creatinine, GOT, GPT), single blood draw volume: 3 c.c., frequency: 1 time, total blood volume: 3 c.c.
It is expected to recruit 20 eligible healthy subjects. This trial adopts a two-stage open crossover trial (Crossover) design. After the subjects join the trial, they need to participate in a total of 2 trials. After each trial is completed, a 14-day interval (washout period) is required before the next trial (the first trial) can be conducted. → 14 days apart → second test). At the beginning of the experiment, the subjects drew lots to determine their numbers and the order of participating groups (the participating groups in the two experiments will not be repeated).
- Conditions
- Nutrition, Healthy
- Being tested
- Satge 1, Stage 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Satge 1Dietary supplement
General vitamin C powder group (Contains 1500 mg Vitamin C) Number 1-10 liposomal encapsulation C powder group (Contains 1500 mg of vitamin C and lecithin and is coated) Number 11-20
Stage 2Dietary supplement
General vitamin C powder group (Contains 1500 mg Vitamin C) Number 11-20 liposomal encapsulation C powder group (Contains 1500 mg of vitamin C and lecithin and is coated) Number 1-10
| Study group | Role | What they receive |
|---|---|---|
| Stage 1 | Other | Day 14 Receives: Dietary Supplement: Satge 1 |
| Stage 2 | Other | Day 28 Receives: Dietary Supplement: Stage 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
General examination
BMI(Body Mass Index is a simple calculation using a person's height and weight. The formula is BMI = kg/m2 where kg is a person's weight in kilograms and m2 is their height in metres squared) and blood pressure
Measured: Day 14 and 28
Hematology Test
Fasting blood glucose, triglycerides, total cholesterol, Blood urea nitrogen, Creatinine(Blood urea nitrogen (BUN) and creatinine tests can be used together to find the BUN-to-creatinine ratio (BUN:creatinine). A BUN-to-creatinine ratio can help your doctor check for problems, such as dehydration, that may cause abnormal BUN and creatinine levels.), GOT, GPT
Measured: Day 14 and 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2024
- Study startApr 2024 (estimated)
- Primary completionSep 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nutrition, HealthyStudies of the same condition, open and under way.
- More trials run by National Yang Ming Chiao Tung UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Yang Ming Chiao Tung University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, YenPing, Lei, National Yang Ming Chiao Tung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06372171
- Sponsor's protocol ID
- NYCU112182AEF
- Status last verified
- Apr 2024
- First submitted
- 24 Mar 2024
- Last updated
- 17 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Liposomal Encapsulation on Vitamin C Absorption and Metabolism
- ClinicalTrials.gov ID
- NCT06372171
- Acronym / sponsor ID
- NYCU112182AEF
- Conditions
- Nutrition, Healthy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- National Yang Ming Chiao Tung UniversityUniversity, hospital or other
- Study start
- Apr 2024 (estimated)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 17 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Vitamin C is an important antioxidant in the human body and plays many important roles. It is currently known that vitamin C has the functions of treating scurvy, assisting in collagen synthesis, whitening, and increasing immunity. Smokers, patients with cardiovascular disease, and patients with diabetes may have higher requirements for vitamins due to higher oxidative stress in the body. Liposome coating is a technology commonly used in food processing and medicine to protect active substances, increase absorption or slow release. Currently, vitamin C is commonly available on the market as an additive nutritional supplement in the form of powder packets, tablets, etc. The disadvantages are that vitamin C is relatively unstable, easily destroyed by gastric acid, and maintains blood concentration for a short time. Taking liposome microbial C has been Found to have the potential to increase bioavailability in the human body, it is expected that vitamin C coated with lecithin is relatively stable and can be stabilized in the small intestine without being damaged by gastric acid, while reducing the risk of gastrointestinal discomfort caused by the acidity of vitamin C. According to the revised seventh edition of the Reference Intake of Dietary Nutrients for Chinese People, the upper daily intake of vitamin C (tolerable upper intake levels, UL) for people aged 19 to 70 is 2,000 mg. According to literature, the absorption rate of vitamin C when consuming 30-180 mg per day is about 70-90%; when the daily intake exceeds 1000 mg, the absorption rate will drop to less than 50%. The dose of vitamin C used in this study is more than 1500 mg. The purpose is to explore whether the sustained-release characteristics of liposome coating technology can improve the absorption rate and achieve better bioavailability when consuming high-dose vitamin C powder. It is expected that through the egg The liposome vitamin C powder made of phospholipids increases its maintenance time in the blood, thereby increasing the supplementary effect of vitamin C powder and serving as another supplement option for vitamin C.
Detailed description
The trial is divided into two parts, the first part is "pre-trial screening" and the second part is "clinical trial".
This trial will first conduct the following tests to confirm that the subjects meet the inclusion and exclusion conditions before screening before they are eligible for the formal trial.
- General examination (height, weight, blood pressure)
- Blood biochemical index detection (fasting blood glucose, triglycerides, total cholesterol, Blood urea nitrogen, Creatinine, GOT, GPT), single blood draw volume: 3 c.c., frequency: 1 time, total blood volume: 3 c.c.
It is expected to recruit 20 eligible healthy subjects. This trial adopts a two-stage open crossover trial (Crossover) design. After the subjects join the trial, they need to participate in a total of 2 trials. After each trial is completed, a 14-day interval (washout period) is required before the next trial (the first trial) can be conducted. → 14 days apart → second test). At the beginning of the experiment, the subjects drew lots to determine their numbers and the order of participating groups (the participating groups in the two experiments will not be repeated).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stage 1 | Other | Dietary Supplement: Satge 1Day 14 |
| Stage 2 | Other | Dietary Supplement: Stage 2Day 28 |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Adults aged 20-60 years old, without heart, liver, kidney, endocrine or major organic diseases (patient report), and able to fully cooperate with the experiment.
Key exclusion criteria (13 listed)
- Patients with renal insufficiency and dialysis
- Cancer patients
- Underweight (BMI≦17) or obese (BMI≧27)
- Those taking medications for chronic diseases
- Blood pressure systolic blood pressure ≧ 130 mmHg or diastolic blood pressure ≧ 85 mmHg
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Satge 1General vitamin C powder group (Contains 1500 mg Vitamin C) Number 1-10 liposomal encapsulation C powder group (Contains 1500 mg of vitamin C and lecithin and is coated) Number 11-20 | Dietary supplement | Stage 1 |
| Stage 2General vitamin C powder group (Contains 1500 mg Vitamin C) Number 11-20 liposomal encapsulation C powder group (Contains 1500 mg of vitamin C and lecithin and is coated) Number 1-10 | Dietary supplement | Stage 2 |
Primary outcome
General examination
Time frame: Day 14 and 28
BMI(Body Mass Index is a simple calculation using a person's height and weight. The formula is BMI = kg/m2 where kg is a person's weight in kilograms and m2 is their height in metres squared) and blood pressure
Hematology Test
Time frame: Day 14 and 28
Fasting blood glucose, triglycerides, total cholesterol, Blood urea nitrogen, Creatinine(Blood urea nitrogen (BUN) and creatinine tests can be used together to find the BUN-to-creatinine ratio (BUN:creatinine). A BUN-to-creatinine ratio can help your doctor check for problems, such as dehydration, that may cause abnormal BUN and creatinine levels.), GOT, GPT
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2024.
- Individual participant dataSharing planned: No
Related trials for Nutrition, Healthy
RecruitingPhase 1
A Study to Learn How Different Forms of the Study Medicine Called Berobenatide is Taken up Into the Blood in Adults With Overweight or Obesity
Overweight and/or Obesity, Healthy Participants
Not yet recruitingPhase 1
A Phase I Clinical Trial of the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Food Effect of UBT48128 Tablets in Healthy Participants
Overweight , Obesity
Not yet recruitingObservational study
Assessing the Impact of Perceptions of Unpredictability on Objective Measures of Food Consumption and Metabolism
Healthy Volunteer, Obestity
Active, not recruitingPhase 1
A Study to Learn About the Study Medicine Called PF-08653944 in Otherwise Healthy Chinese Adults With Overweight or Obesity
Overweight, Obesity
Recruiting
Nutrition Outcomes Using a Randomized Intervention Via Smartphone on Dietary Habits
Healthy Adult Participants, Mindful Eating Intervention
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Satge 1 and Stage 2 in people with Nutrition, Healthy, run by National Yang Ming Chiao Tung University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact ChienYu Huang, Bachelor (+886-955-879163, chienyu.ns11@nycu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
General examination (time frame: Day 14 and 28). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2024.