Postprandial LipemiaNCT07824609
Effect of Standardized Large Yellow Tea Extract on Triglyceride Response After a High-Fat Meal in Healthy Adults
A study testing Standardized Large Yellow Tea Extract in people with Postprandial Lipemia, run by The First Affiliated Hospital of China University of Science and Technology (Anhui Provincial).
Trial summary
This study is a single-center, prospective, open-label, randomized 2×2 crossover controlled trial in healthy adults aged 18 to 45 years. The study aims to evaluate the acute effect of a standardized large yellow tea extract on triglyceride responses after a standardized high-fat meal. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Postprandial Lipemia
- What is being tested?
- Standardized Large Yellow Tea Extract
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- Sep 2026to Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Voluntary participation in the study, with full understanding of the study objectives, procedures, and potential risks, and provision of written informed consent.
- Healthy adults aged 18 to 45 years, male or female.
- Body mass index (BMI) of 18.5 to 24.0 kg/m², with relatively stable body weight (change <5% during the previous 3 months).
- Generally normal physical examination and vital signs, including:
- Systolic blood pressure: 90-139 mmHg;
- Diastolic blood pressure: 60-89 mmHg;
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- Resting heart rate: 50-100 beats/min;
- No clinically significant abnormal physical findings.
- Baseline laboratory results meeting the following criteria:
- Complete blood count within the reference range, or minor deviations considered clinically insignificant by the investigator;
- ALT, AST, ALP, GGT, and total bilirubin within the upper limit of normal (ULN), or no more than 1.2 × ULN and considered clinically insignificant by the investigator;
- Serum creatinine and blood urea nitrogen within the reference range and estimated glomerular filtration rate (eGFR) ≥90 mL/min/1.73 m²;
- Fasting plasma glucose approximately 3.9-6.1 mmol/L, without a diagnosis of diabetes or prediabetes;
- Triglycerides <2.3 mmol/L and LDL-C <4.1 mmol/L, or according to the reference ranges of the local laboratory and investigator judgment.
- No history of serious cardiovascular, hepatic, renal, gastrointestinal, respiratory, neurological, hematological, endocrine, or other major systemic disease, or only mild chronic conditions considered by the investigator not to substantially affect study safety or outcomes.
- No known allergy to tea or its components, including tea polyphenols or caffeine, and no history of serious adverse reactions after tea or caffeine-containing beverages.
- No regular use during the previous month of lipid-lowering drugs, glucose-lowering drugs, antihypertensive drugs, glucocorticoids, high-dose antioxidant supplements, weight-loss products, or other medications or supplements that may affect glucose or lipid metabolism or pharmacokinetic outcomes.
- Moderate intake of tea, coffee, and other caffeine-containing beverages during the previous week, and willingness to restrict other tea and caffeine-containing beverages from 3 days before the study until completion of the study.
- No alcohol abuse or drug abuse.
- Ability and willingness to comply with all study procedures, including scheduled visits, blood and urine sampling, and recording of medications and adverse events.
Who cannot join
- Known or suspected allergy to tea, tea polyphenols, caffeine, theanine, or any component of the study product, or a history of severe allergic reactions.
- History or current presence of clinically important cardiovascular, hepatic, renal, gastrointestinal, endocrine/metabolic, neurological, psychiatric, or other systemic disease that, in the investigator's judgment, may affect participant safety or study outcomes.
- Any history of malignant tumor or current treatment for malignancy.
- Clinically significant baseline laboratory abnormalities, including but not limited to:
- ALT or AST >1.5 × ULN;
- Total bilirubin >1.5 × ULN;
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- Serum creatinine above the upper limit of normal or eGFR <90 mL/min/1.73 m²;
- Clinically significant abnormalities in complete blood count;
- Fasting plasma glucose ≥6.1 mmol/L or HbA1c ≥6.5%.
- Use within the previous 3 months of lipid-lowering drugs, glucose-lowering drugs, long-term systemic glucocorticoids, anticoagulants, antiarrhythmic drugs, or strong enzyme-inducing or transporter-modifying drugs that may interfere with study outcomes.
- Regular use within the previous month of high-dose antioxidants, dietary supplements, herbal preparations, green tea extract, grape seed extract, ginseng, Ganoderma lucidum, or other lipid- or glucose-modifying supplements considered likely to interfere with the study.
- Participation in another clinical trial or healthy-volunteer study within the previous 3 months, receipt of an investigational drug or device, or blood donation/blood loss ≥400 mL within the previous 3 months.
- Alcohol or drug abuse, or marked caffeine sensitivity causing symptoms such as palpitations, insomnia, tremor, or anxiety after small amounts of coffee, strong tea, or other caffeine-containing beverages.
- Pregnancy, breastfeeding, planned pregnancy within the next 3 months, or refusal by women of childbearing potential to use reliable contraception during the study.
- Significant circadian rhythm disturbance, long-term night-shift or rotating-shift work, severely irregular sleep, or anticipated travel/work scheduling likely to interfere with study visits or sampling.
- Any condition considered by the investigator likely to result in poor compliance or inability to complete study procedures.
- Any other condition that, in the investigator's judgment, makes the individual unsuitable for participation.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effect of Standardized Large Yellow Tea Extract on Postprandial Triglyceride Response to a High-Fat Meal in Healthy Adults: A Randomized Crossover Controlled Trial
This study is a single-center, prospective, open-label, randomized 2×2 crossover controlled trial in healthy adults aged 18 to 45 years. The study aims to evaluate the acute effect of a standardized large yellow tea extract on triglyceride responses after a standardized high-fat meal.
Participants will be randomly assigned to one of two intervention sequences. In one study period, participants will consume 3 g of standardized large yellow tea extract dissolved in 250 mL of warm water after a standardized high-fat meal. In the other period, they will consume 250 mL of warm water as the control. The two study periods will be separated by a washout period of at least 7 days.
Blood samples will be collected before the meal and at 0.5, 1, 1.5, 2, 4, and 6 hours after the meal. The primary outcome is the incremental area under the curve for plasma triglycerides from 0 to 6 hours. Secondary and exploratory outcomes include other postprandial lipid and metabolic measures, safety and tolerability, and plasma and urine metabolomic profiles.
Read the detailed description
The study will enroll healthy adults aged 18 to 45 years who meet predefined clinical and laboratory eligibility criteria. Participants will be randomized in a 1:1 ratio to one of two crossover sequences: Tea-Water (TW) or Water-Tea (WT). Each participant will therefore receive both interventions during the study.
In the tea intervention period, participants will consume a single dose of 3 g of standardized large yellow tea extract dissolved in 250 mL of warm water. In the control period, participants will consume 250 mL of warm water. Both interventions will be administered immediately after completion of a standardized high-fat meal. The two intervention periods will be separated by a washout period of at least 7 days.
On each study day, participants will arrive after an overnight fast. A baseline blood sample will be collected before consumption of the standardized high-fat meal. The meal will be completed within 20 minutes, followed immediately by the assigned study beverage, which will be consumed within 10 minutes. Additional blood samples will be collected at 0.5, 1, 1.5, 2, 4, and 6 hours after the meal.
The primary outcome is the 0- to 6-hour incremental area under the curve for plasma triglycerides. Secondary outcomes include postprandial triglyceride kinetics, triglyceride peak concentration and time to peak, and selected lipid-related measures. Exploratory analyses will assess additional metabolic measures and plasma and urine metabolomic profiles to identify potential exposure biomarkers and metabolic pathways associated with the triglyceride response.
Although the study is open-label to participants and study staff, biological samples will be coded, and laboratory personnel and statistical analysts will remain blinded to treatment assignment when feasible. Safety and tolerability will be assessed through adverse-event monitoring, vital signs, and relevant laboratory assessments.
- Conditions
- Postprandial Lipemia
- Being tested
- Standardized Large Yellow Tea Extract, Warm Water Control
- Keywords
- Large Yellow Tea, Postprandial Triglycerides, High-Fat Meal, Oral Fat Tolerance Test, Crossover Trial, Metabolomics, Healthy Adults
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standardized Large Yellow Tea ExtractDietary supplement
A single dose of 3 g of standardized large yellow tea extract is dissolved in 250 mL of warm water at 60±5°C and consumed within 10 minutes immediately after completion of the standardized high-fat meal.
Warm Water ControlOther
Participants consume 250 mL of warm water at 60±5°C within 10 minutes immediately after completion of the standardized high-fat meal as the control intervention.
| Study group | Role | What they receive |
|---|---|---|
| Tea-Water Sequence (TW) | Experimental | Participants receive 3 g of standardized large yellow tea extract dissolved in 250 mL of warm water in Period 1. After a washout period of at least 7 days, participants receive 250 mL of warm water as the control in Period 2. Both interventions are administered immediately after completion of the standardized high-fat meal. Receives: Dietary Supplement: Standardized Large Yellow Tea Extract; Other: Warm Water Control |
| Water-Tea Sequence (WT) | Experimental | Participants receive 250 mL of warm water as the control in Period 1. After a washout period of at least 7 days, participants receive 3 g of standardized large yellow tea extract dissolved in 250 mL of warm water in Period 2. Both interventions are administered immediately after completion of the standardized high-fat meal. Receives: Dietary Supplement: Standardized Large Yellow Tea Extract; Other: Warm Water Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postprandial Plasma Triglyceride Incremental Area Under the Curve From 0 to 6 Hours (TG iAUC0-6h)
The incremental area under the curve (iAUC) for plasma triglyceride concentrations will be calculated relative to the fasting baseline value using the trapezoidal method. Plasma triglycerides will be measured at 0 (baseline), 0.5, 1, 1.5, 2, 4, and 6 hours after the standardized high-fat meal.
Measured: 0 to 6 hours after the standardized high-fat meal during each intervention period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2026
- Study startSep 2026 (estimated)
- Primary completionOct 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postprandial LipemiaStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Participants will be randomized in a 1:1 ratio to one of two crossover sequences: Tea-Water (TW) or Water-Tea (WT). Each participant will receive both interventions in two study periods separated by a washout period of at least 7 days.
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of China University of Science and Technology (Anhui Provincial)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yongliang Zhang, The First Affiliated Hospital of China University of Science and Technology (Anhui Provincial)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07824609
- Sponsor's protocol ID
- 2026-ky292
- Status last verified
- Sep 2026
- First submitted
- 10 Sep 2026
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared with other researchers because the informed consent specifies that study data and biological samples will be used only for this study and are not planned for sharing or secondary use.
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Standardized Large Yellow Tea Extract on Postprandial Triglyceride Response to a High-Fat Meal in Healthy Adults: A Randomized Crossover Controlled Trial
- ClinicalTrials.gov ID
- NCT07824609
- Acronym / sponsor ID
- 2026-ky292
- Conditions
- Postprandial Lipemia
- Keywords
- Large Yellow Tea, Postprandial Triglycerides, High-Fat Meal, Oral Fat Tolerance Test, Crossover Trial, Metabolomics, Healthy Adults
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of China University of Science and Technology (Anhui Provincial)University, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 17 Sep 2026 (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 is a single-center, prospective, open-label, randomized 2×2 crossover controlled trial in healthy adults aged 18 to 45 years. The study aims to evaluate the acute effect of a standardized large yellow tea extract on triglyceride responses after a standardized high-fat meal.
Participants will be randomly assigned to one of two intervention sequences. In one study period, participants will consume 3 g of standardized large yellow tea extract dissolved in 250 mL of warm water after a standardized high-fat meal. In the other period, they will consume 250 mL of warm water as the control. The two study periods will be separated by a washout period of at least 7 days.
Blood samples will be collected before the meal and at 0.5, 1, 1.5, 2, 4, and 6 hours after the meal. The primary outcome is the incremental area under the curve for plasma triglycerides from 0 to 6 hours. Secondary and exploratory outcomes include other postprandial lipid and metabolic measures, safety and tolerability, and plasma and urine metabolomic profiles.
Detailed description
The study will enroll healthy adults aged 18 to 45 years who meet predefined clinical and laboratory eligibility criteria. Participants will be randomized in a 1:1 ratio to one of two crossover sequences: Tea-Water (TW) or Water-Tea (WT). Each participant will therefore receive both interventions during the study.
In the tea intervention period, participants will consume a single dose of 3 g of standardized large yellow tea extract dissolved in 250 mL of warm water. In the control period, participants will consume 250 mL of warm water. Both interventions will be administered immediately after completion of a standardized high-fat meal. The two intervention periods will be separated by a washout period of at least 7 days.
On each study day, participants will arrive after an overnight fast. A baseline blood sample will be collected before consumption of the standardized high-fat meal. The meal will be completed within 20 minutes, followed immediately by the assigned study beverage, which will be consumed within 10 minutes. Additional blood samples will be collected at 0.5, 1, 1.5, 2, 4, and 6 hours after the meal.
The primary outcome is the 0- to 6-hour incremental area under the curve for plasma triglycerides. Secondary outcomes include postprandial triglyceride kinetics, triglyceride peak concentration and time to peak, and selected lipid-related measures. Exploratory analyses will assess additional metabolic measures and plasma and urine metabolomic profiles to identify potential exposure biomarkers and metabolic pathways associated with the triglyceride response.
Although the study is open-label to participants and study staff, biological samples will be coded, and laboratory personnel and statistical analysts will remain blinded to treatment assignment when feasible. Safety and tolerability will be assessed through adverse-event monitoring, vital signs, and relevant laboratory assessments.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomized in a 1:1 ratio to one of two crossover sequences: Tea-Water (TW) or Water-Tea (WT). Each participant will receive both interventions in two study periods separated by a washout period of at least 7 days.
| Arm | Type | Receives |
|---|---|---|
| Tea-Water Sequence (TW) | Experimental | Dietary Supplement: Standardized Large Yellow Tea Extract, Other: Warm Water ControlParticipants receive 3 g of standardized large yellow tea extract dissolved in 250 mL of warm water in Period 1. After a washout period of at least 7 days, participants receive 250 mL of warm water as the control in Period 2. Both interventions are administered immediately after completion of the standardized high-fat meal. |
| Water-Tea Sequence (WT) | Experimental | Dietary Supplement: Standardized Large Yellow Tea Extract, Other: Warm Water ControlParticipants receive 250 mL of warm water as the control in Period 1. After a washout period of at least 7 days, participants receive 3 g of standardized large yellow tea extract dissolved in 250 mL of warm water in Period 2. Both interventions are administered immediately after completion of the standardized high-fat meal. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (20 listed)
- Voluntary participation in the study, with full understanding of the study objectives, procedures, and potential risks, and provision of written informed consent.
- Healthy adults aged 18 to 45 years, male or female.
- Body mass index (BMI) of 18.5 to 24.0 kg/m², with relatively stable body weight (change <5% during the previous 3 months).
- Generally normal physical examination and vital signs, including:
- Baseline laboratory results meeting the following criteria:
Key exclusion criteria (17 listed)
- Known or suspected allergy to tea, tea polyphenols, caffeine, theanine, or any component of the study product, or a history of severe allergic reactions.
- History or current presence of clinically important cardiovascular, hepatic, renal, gastrointestinal, endocrine/metabolic, neurological, psychiatric, or other systemic disease that, in the investigator's judgment, may affect participant safety or study outcomes.
- Any history of malignant tumor or current treatment for malignancy.
- Clinically significant baseline laboratory abnormalities, including but not limited to:
- Use within the previous 3 months of lipid-lowering drugs, glucose-lowering drugs, long-term systemic glucocorticoids, anticoagulants, antiarrhythmic drugs, or strong enzyme-inducing or transporter-modifying drugs that may interfere with study outcomes.
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 |
|---|---|---|
| Standardized Large Yellow Tea ExtractA single dose of 3 g of standardized large yellow tea extract is dissolved in 250 mL of warm water at 60±5°C and consumed within 10 minutes immediately after completion of the standardized high-fat meal. | Dietary supplement | Tea-Water Sequence (TW), Water-Tea Sequence (WT) |
| Warm Water ControlParticipants consume 250 mL of warm water at 60±5°C within 10 minutes immediately after completion of the standardized high-fat meal as the control intervention. | Other | Tea-Water Sequence (TW), Water-Tea Sequence (WT) |
Primary outcome
Postprandial Plasma Triglyceride Incremental Area Under the Curve From 0 to 6 Hours (TG iAUC0-6h)
Time frame: 0 to 6 hours after the standardized high-fat meal during each intervention period
The incremental area under the curve (iAUC) for plasma triglyceride concentrations will be calculated relative to the fasting baseline value using the trapezoidal method. Plasma triglycerides will be measured at 0 (baseline), 0.5, 1, 1.5, 2, 4, and 6 hours after the standardized high-fat meal.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared with other researchers because the informed consent specifies that study data and biological samples will be used only for this study and are not planned for sharing or secondary use.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Standardized Large Yellow Tea Extract in people with Postprandial Lipemia, run by The First Affiliated Hospital of China University of Science and Technology (Anhui Provincial).
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 20 inclusion and 17 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: opening soon, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mengjun Tao (+86-17398374118, tmj0553@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postprandial Plasma Triglyceride Incremental Area Under the Curve From 0 to 6 Hours (TG iAUC0-6h) (time frame: 0 to 6 hours after the standardized high-fat meal during each intervention period). 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 Sep 2026.