Bioavailability and PharmacokineticsGT Safety & BANCT06971536
Safety and Bioavailability of Micellar Green Tea Extract
A study testing Standard Green Tea, Phytosome Green Tea and LipoMicel Green Tea in people with Bioavailability and Pharmacokinetics and Safety, run by Isura at 1 site in Canada.
Trial summary
This study seeks to determine the short-term effects of daily oral supplementation of LipoMicel Green Tea on oral absorption and safety of green tea in healthy volunteers. The primary objective is to evaluate and compare the pharmacokinetics of LipoMicel Green Tea (LGT) with that of a standard green tea extract… Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Bioavailability and Pharmacokinetics, Safety
- What is being tested?
- Standard Green Tea, Phytosome Green Tea and LipoMicel Green Tea
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteCanada
- Study dates
- 10 Dec 2023to 30 Mar 2025
- 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 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- male or female aged 21-65 years
- healthy, good physical condition
- voluntary, written, informed consent to participate in the study.
Who cannot join
- use of anti-inflammatory or non-steroidal anti-inflammatory drugs
- previous history of cardiovascular disease or acute or chronic inflammatory disease
- use of antioxidant supplements or cholesterol-lowering agents
- change of diet habits or lifestyle (diet, physical activity, etc.)
- alcohol or substance abuse history
- use of nicotine or tobacco
- participation in another investigational study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Human Clinical Trial on the Pharmacokinetics and Safety of Oral Micellar Green Tea Extract
This study seeks to determine the short-term effects of daily oral supplementation of LipoMicel Green Tea on oral absorption and safety of green tea in healthy volunteers.
The primary objective is to evaluate and compare the pharmacokinetics of LipoMicel Green Tea (LGT) with that of a standard green tea extract formulation as well as a phytosomal green tea formulation. The secondary objective is to evaluate the safety of LGT in healthy human participants over a 30-day study period.
- Conditions
- Bioavailability and Pharmacokinetics, Safety
- Being tested
- Standard Green Tea, Phytosome Green Tea, LipoMicel Green Tea
- Keywords
- pharmacokinetics, green tea extract, bioavailability, safety, micellar delivery system
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Green TeaDietary supplement
A maximum single dose of 300 mg green tea (hard gel capsules)
Phytosome Green TeaDietary supplement
A maximum single dose of 250 mg green tea (hard gel capsules)
LipoMicel Green TeaDietary supplement
A maximum single dose of 300 mg green tea (soft gel capsules)
| Study group | Role | What they receive |
|---|---|---|
| Standard Green Tea | Experimental | Each participant receives their treatment i.e., Standard Green Tea hard gel capsules at a total dose of 300 mg green tea extract. Treatments are consumed with a glass of water (approx. 200mL), followed by a standardized breakfast (diet-controlled condition). Capillary whole blood samples are collected at different time points up to 48 hours post-dose. A washout period of at least 7 days between each treatment is used. Receives: Dietary Supplement: Standard Green Tea |
| Phytosome Green Tea | Experimental | Each participant receives their treatment i.e., Phytosome green tea hard gel capsules at a total dose of 250 mg green tea extract. Treatments are consumed with a glass of water (approx. 200mL), followed by a standardized breakfast (diet-controlled condition). Capillary whole blood samples are collected at different time points up to 48 hours post-dose. A washout period of at least 7 days between each treatment is used. Receives: Dietary Supplement: Phytosome Green Tea |
| LipoMicel Green Tea | Experimental | Each participant receives their treatment i.e., LipoMicel green tea soft gel capsules at a total dose of 300 mg green tea extract. Treatments are consumed with a glass of water (approx. 200mL), followed by a standardized breakfast (diet-controlled condition). Capillary whole blood samples are collected at different time points up to 48 hours post-dose. A washout period of at least 7 days between each treatment is used. Receives: Dietary Supplement: LipoMicel Green Tea |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC: the area under the concentration-time curve
To determine the gastrointestinal absorption of orally ingested green tea extract in healthy adult volunteers and compare the Area under the plasma concentration versus time curve (AUC) with that of other capsules containing green tea extract.
Measured: 0 (baseline; pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 12, 24, 48 hours (post-dose)
Cmax: maximum plasma concentration
To determine the gastrointestinal absorption of orally ingested green tea extract in healthy adult volunteers and compare the peak plasma concentration (Cmax) with that of other capsules containing green tea extract.
Measured: 0 (baseline; pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 12, 24, 48 hours (post-dose)
Tmax: the time point of maximum plasma concentration
To determine the gastrointestinal absorption of orally ingested green tea extract in healthy adult volunteers and compare the time point of maximum plasma concentration (Tmax) with that of other capsules containing green tea extract.
Measured: 0 (baseline; pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 12, 24, 48 hours (post-dose)
Secondary outcomes (10)
Alanine aminotransferase (ALT)
To evaluate changes in liver function based on ALT.
Measured: 0 (baseline; pre-dose), week 2 and week 4 (post-dose)
Aspartate aminotransferase (AST)
To evaluate changes in liver function based on AST.
Measured: 0 (baseline; pre-dose), week 2 and week 4 (post-dose)
Total bilirubin (TB)
To evaluate changes in liver function based on total bilirubin.
Measured: 0 (baseline; pre-dose), week 2 and week 4 (post-dose)
Serum creatinine
To evaluate changes in kidney function based on serum creatinine.
Measured: 0 (baseline; pre-dose), week 2 and week 4 (post-dose)
Glomerular filtration rate (GFR)
To evaluate changes in kidney function based on GFR.
Measured: 0 (baseline; pre-dose), week 2 and week 4 (post-dose)
Fasting blood glucose
To evaluate changes in blood glucose levels based on fasting blood glucose.
Measured: 0 (baseline; pre-dose), week 2 and week 4 (post-dose)
Total cholesterol
To evaluate changes in lipid profile based on total cholesterol.
Measured: 0 (baseline; pre-dose), week 2 and week 4 (post-dose)
Triglycerides
To evaluate changes in lipid profile based on triglycerides.
Measured: 0 (baseline; pre-dose), week 2 and week 4 (post-dose)
Low-density lipoprotein (LDL) cholesterol
To evaluate changes in lipid profile based on LDL.
Measured: 0 (baseline; pre-dose), week 2 and week 4 (post-dose)
High-density lipoprotein (HDL) cholesterol
To evaluate changes in lipid profile based on HDL.
Measured: 0 (baseline; pre-dose), week 2 and week 4 (post-dose)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2025
- Study start10 Dec 2023
- Primary completion13 Sep 2024
- Study completion30 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bioavailability and PharmacokineticsStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Participants are randomly assigned to interventions in a crossover design to assess the pharmacokinetics over 48 hours; subsequently, the safety of LipoMicel Green tea intervention with the higher bioavailability is evaluated in a subsequent single-arm, 30-day trial.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Isura
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Julia Solnier, Principal investigator, Isura
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06971536
- Sponsor's protocol ID
- 2022-11-002GT
- Acronym
- GT Safety & BA
- Status last verified
- May 2025
- First submitted
- 6 May 2025
- Last updated
- 14 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhang Y, Ibi A, Kuo YC, Do P, Du M, Roh YS, Gahler R, Hardy M, Wood S, Chang C, Solnier J. Enhanced bioavailability and short-term safety of a micellar green tea extract formulation co-delivered with N-acetylcysteine: a randomized crossover study in healthy adults. Front Nutr. 2026 Sep 23;13:1940156. doi: 10.3389/fnut.2026.1940156. eCollection 2026.
PubMed 42846898
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Human Clinical Trial on the Pharmacokinetics and Safety of Oral Micellar Green Tea Extract
- ClinicalTrials.gov ID
- NCT06971536
- Acronym / sponsor ID
- GT Safety & BA / 2022-11-002GT
- Conditions
- Bioavailability and Pharmacokinetics, Safety
- Keywords
- pharmacokinetics, green tea extract, bioavailability, safety, micellar delivery system
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- IsuraUniversity, hospital or other
- Study start
- 10 Dec 2023 (actual)
- Primary completion
- 13 Sep 2024 (actual)
- Study completion
- 30 Mar 2025 (actual)
- First posted
- 14 May 2025 (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.
This study seeks to determine the short-term effects of daily oral supplementation of LipoMicel Green Tea on oral absorption and safety of green tea in healthy volunteers.
The primary objective is to evaluate and compare the pharmacokinetics of LipoMicel Green Tea (LGT) with that of a standard green tea extract formulation as well as a phytosomal green tea formulation. The secondary objective is to evaluate the safety of LGT in healthy human participants over a 30-day study period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- Participants are randomly assigned to interventions in a crossover design to assess the pharmacokinetics over 48 hours; subsequently, the safety of LipoMicel Green tea intervention with the higher bioavailability is evaluated in a subsequent single-arm, 30-day trial.
| Arm | Type | Receives |
|---|---|---|
| Standard Green Tea | Experimental | Dietary Supplement: Standard Green TeaEach participant receives their treatment i.e., Standard Green Tea hard gel capsules at a total dose of 300 mg green tea extract. Treatments are consumed with a glass of water (approx. 200mL), followed by a standardized breakfast (diet-controlled condition). Capillary whole blood samples are collected at different time points up to 48 hours post-dose. A washout period of at least 7 days between each treatment is used. |
| Phytosome Green Tea | Experimental | Dietary Supplement: Phytosome Green TeaEach participant receives their treatment i.e., Phytosome green tea hard gel capsules at a total dose of 250 mg green tea extract. Treatments are consumed with a glass of water (approx. 200mL), followed by a standardized breakfast (diet-controlled condition). Capillary whole blood samples are collected at different time points up to 48 hours post-dose. A washout period of at least 7 days between each treatment is used. |
| LipoMicel Green Tea | Experimental | Dietary Supplement: LipoMicel Green TeaEach participant receives their treatment i.e., LipoMicel green tea soft gel capsules at a total dose of 300 mg green tea extract. Treatments are consumed with a glass of water (approx. 200mL), followed by a standardized breakfast (diet-controlled condition). Capillary whole blood samples are collected at different time points up to 48 hours post-dose. A washout period of at least 7 days between each treatment is used. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- male or female aged 21-65 years
- healthy, good physical condition
- voluntary, written, informed consent to participate in the study.
Key exclusion criteria (7 listed)
- use of anti-inflammatory or non-steroidal anti-inflammatory drugs
- previous history of cardiovascular disease or acute or chronic inflammatory disease
- use of antioxidant supplements or cholesterol-lowering agents
- change of diet habits or lifestyle (diet, physical activity, etc.)
- alcohol or substance abuse history
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 |
|---|---|---|
| Standard Green TeaA maximum single dose of 300 mg green tea (hard gel capsules) | Dietary supplement | Standard Green Tea |
| Phytosome Green TeaA maximum single dose of 250 mg green tea (hard gel capsules) | Dietary supplement | Phytosome Green Tea |
| LipoMicel Green TeaA maximum single dose of 300 mg green tea (soft gel capsules) | Dietary supplement | LipoMicel Green Tea |
Primary outcome
AUC: the area under the concentration-time curve
Time frame: 0 (baseline; pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 12, 24, 48 hours (post-dose)
To determine the gastrointestinal absorption of orally ingested green tea extract in healthy adult volunteers and compare the Area under the plasma concentration versus time curve (AUC) with that of other capsules containing green tea extract.
Cmax: maximum plasma concentration
Time frame: 0 (baseline; pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 12, 24, 48 hours (post-dose)
To determine the gastrointestinal absorption of orally ingested green tea extract in healthy adult volunteers and compare the peak plasma concentration (Cmax) with that of other capsules containing green tea extract.
Tmax: the time point of maximum plasma concentration
Time frame: 0 (baseline; pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 12, 24, 48 hours (post-dose)
To determine the gastrointestinal absorption of orally ingested green tea extract in healthy adult volunteers and compare the time point of maximum plasma concentration (Tmax) with that of other capsules containing green tea extract.
10 secondary outcomes
Alanine aminotransferase (ALT)
Time frame: 0 (baseline; pre-dose), week 2 and week 4 (post-dose)
Aspartate aminotransferase (AST)
Time frame: 0 (baseline; pre-dose), week 2 and week 4 (post-dose)
Total bilirubin (TB)
Time frame: 0 (baseline; pre-dose), week 2 and week 4 (post-dose)
Serum creatinine
Time frame: 0 (baseline; pre-dose), week 2 and week 4 (post-dose)
Glomerular filtration rate (GFR)
Time frame: 0 (baseline; pre-dose), week 2 and week 4 (post-dose)
Fasting blood glucose
Time frame: 0 (baseline; pre-dose), week 2 and week 4 (post-dose)
Total cholesterol
Time frame: 0 (baseline; pre-dose), week 2 and week 4 (post-dose)
Triglycerides
Time frame: 0 (baseline; pre-dose), week 2 and week 4 (post-dose)
Low-density lipoprotein (LDL) cholesterol
Time frame: 0 (baseline; pre-dose), week 2 and week 4 (post-dose)
High-density lipoprotein (HDL) cholesterol
Time frame: 0 (baseline; pre-dose), week 2 and week 4 (post-dose)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2025.
- Derived from this study: PubMed 42846898Zhang Y, Ibi A, Kuo YC, Do P, Du M, Roh YS, Gahler R, Hardy M, Wood S, Chang C, Solnier J. Enhanced bioavailability and short-term safety of a micellar green tea extract formulation co-delivered with N-acetylcysteine: a randomized crossover study in healthy adults. Front Nutr. 2026 Sep 23;13:1940156. doi: 10.3389/fnut.2026.1940156. eCollection 2026.
- Individual participant dataSharing planned: No
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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.
Julia Solnier principal investigator
Isura
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard Green Tea, Phytosome Green Tea and LipoMicel Green Tea in people with Bioavailability and Pharmacokinetics and Safety, run by Isura at 1 site in Canada.
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 3 inclusion and 7 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: finished, as of the sponsor's last update on 14 May 2025. 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 Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUC: the area under the concentration-time curve (time frame: 0 (baseline; pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 12, 24, 48 hours (post-dose)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06971536, which also lists 1 linked publication.
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 14 May 2025.