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HypertriglyceridemiaNCT07840846

Standardized Large Yellow Tea Extract for Glucose and Lipid Metabolism in Overweight Adults With Hypertriglyceridemia

A study testing Standardized Large Yellow Tea Extract in people with Hypertriglyceridemia and Overweight , Obesity, run by The First Affiliated Hospital of China University of Science and Technology (Anhui Provincial).

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

This multicenter, prospective, randomized, blinded, parallel-group controlled trial will evaluate the effects of standardized large yellow tea extract on glucose and lipid metabolism in overweight adults with elevated triglyceride levels. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Hypertriglyceridemia, Overweight , Obesity
What is being tested?
Standardized Large Yellow Tea Extract
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
138 participants
Where
No sites listed yet
Study dates
Sep 2026to Mar 2028
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 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Voluntarily participates in the study, fully understands the study objectives, procedures, and potential risks, and provides written informed consent.
  • Aged 18 to 60 years, either sex.
  • Body mass index (BMI) ≥24.0 kg/m², with body weight fluctuation <5% during the previous 3 months.
  • Elevated fasting triglyceride (TG) level, consistent with hypertriglyceridemia or a high-normal/elevated triglyceride status.
  • General health condition is stable, with no clinically significant abnormalities in vital signs or physical examination as judged by the investigator.
  • Baseline laboratory tests show no clinically significant abnormalities; complete blood count, liver function, and renal function are considered acceptable by the investigator for safe participation.
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  • No diagnosis of diabetes mellitus and no regular use of glucose-lowering medications during the previous 3 months.
  • No regular use during the previous month of medications, dietary supplements, or tea extract products that may substantially affect glucose or lipid metabolism.
  • Able to understand and comply with the study requirements and willing to complete the 12-week intervention and follow-up, with acceptable anticipated adherence as judged by the investigator.

Who cannot join

  • Known or suspected allergy to tea, tea polyphenols, caffeine, or any component of the study products, or a history of severe allergic reactions.
  • Presence of any of the following cardiovascular or high-risk conditions:
  • Established coronary atherosclerotic heart disease, including myocardial infarction, unstable angina, or previous coronary revascularization;
  • Cerebrovascular disease, including stroke or transient ischemic attack;
  • Peripheral arterial disease;
  • Hypertension, defined as systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg, or current use of antihypertensive medication;
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  • Diagnosed type 1 or type 2 diabetes mellitus;
  • Other serious cardiovascular or cerebrovascular disease that, in the investigator's judgment, may increase participant risk or interfere with assessment of study outcomes.
  • Severe abnormalities of glucose or lipid metabolism, including diabetes mellitus.
  • Clinically significant baseline laboratory abnormalities, including ALT or AST >1.5 times the upper limit of normal, total bilirubin >1.5 times the upper limit of normal, significantly reduced renal function, or clinically significant abnormalities in complete blood count as judged by the investigator.
  • Use within the previous 3 months of lipid-lowering medications, weight-loss medications, long-term systemic glucocorticoids, or other medications that may substantially affect glucose or lipid metabolism; or regular use within the previous month of high-dose antioxidants, fish oil, plant sterols, tea extracts, or other products that may affect study outcomes.
  • Participation in another clinical trial within the previous 3 months, or blood donation/blood loss ≥400 mL within the previous 3 months.
  • Pregnant or breastfeeding women, women planning pregnancy during the study, or participants unwilling to use effective contraception when applicable.
  • Alcohol abuse, drug abuse, poor anticipated adherence, or any other condition considered by the investigator to make participation inappropriate.

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 Glucose and Lipid Metabolism in Overweight Adults With Hypertriglyceridemia: A Randomized Controlled Trial

This multicenter, prospective, randomized, blinded, parallel-group controlled trial will evaluate the effects of standardized large yellow tea extract on glucose and lipid metabolism in overweight adults with elevated triglyceride levels.

Approximately 138 participants aged 18 to 60 years will be enrolled at three study centers in China and randomly assigned in a 1:2 ratio to a placebo control group or a standardized large yellow tea extract group. Participants will receive the assigned intervention for 12 weeks, together with standardized lifestyle guidance.

Read more

The primary objective is to compare the change in fasting triglyceride levels from baseline to week 12 between the two groups. Secondary objectives include evaluating changes in other lipid parameters, glucose metabolism, body weight, body mass index, waist circumference, blood pressure, and safety and tolerability. Exploratory analyses will assess plasma and/or urine metabolomic profiles and potential biomarkers related to response to the tea intervention.

Participants will also be followed through week 24 for longer-term safety assessment and changes in glucose and lipid metabolism.

Read the detailed description

This study is a multicenter, prospective, randomized, blinded, parallel-group controlled intervention trial conducted at the First Affiliated Hospital of USTC, Huangshan People's Hospital, and Lu'an People's Hospital in China.

Eligible participants will be adults aged 18 to 60 years who are overweight or obese, defined as a body mass index of at least 24.0 kg/m², and who have elevated fasting triglyceride levels without diagnosed diabetes or major cardiovascular disease. After screening and confirmation of eligibility, participants will be randomized in a 1:2 ratio to the placebo control group or the standardized large yellow tea extract group.

The intervention period will last 12 weeks. Both groups will receive standardized lifestyle guidance covering diet, physical activity, and sleep. Lifestyle-related factors will be assessed using dietary records, the International Physical Activity Questionnaire, and the Pittsburgh Sleep Quality Index. Adherence, concomitant medication use, and adverse events will be monitored throughout the intervention period.

Study visits are planned at screening, baseline, week 4, week 8, and week 12. Fasting blood samples will be collected for efficacy and safety assessments according to the study schedule. The primary efficacy endpoint is the change in fasting triglyceride concentration from baseline to week 12.

Secondary assessments include total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, non-high-density lipoprotein cholesterol, apolipoprotein A1, apolipoprotein B, fasting plasma glucose, fasting insulin, HOMA-IR, body weight, body mass index, waist circumference, blood pressure, and heart rate. Safety assessments include adverse events, laboratory safety parameters, and tolerability.

Exploratory analyses will investigate changes in plasma and/or urine metabolomic profiles, identify metabolites associated with exposure to large yellow tea extract, and explore associations between candidate biomarkers and triglyceride response.

After completion of the 12-week intervention, participants will continue follow-up through week 24 for evaluation of longer-term safety and changes in glucose and lipid metabolism.

Being tested
Standardized Large Yellow Tea Extract, Placebo
Keywords
Large Yellow Tea, Triglycerides, Lipid Metabolism, Glucose Metabolism, Metabolomics
Medical subject headings
Hypertriglyceridemia, Overweight, Obesity

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

    Standardized large yellow tea extract powder, 3 g per dose, administered orally twice daily, approximately 30 minutes after breakfast and 30 minutes after dinner, for 12 weeks. The product is prepared in 200-300 mL of warm water and consumed within 10 minutes.

  • PlaceboDietary supplement

    Matching placebo powder containing excipients such as maltodextrin and vitamin C and no active large yellow tea components. The placebo is matched to the active product in appearance, color, taste, packaging, and administration schedule and is given for 12 weeks.

Study groups in NCT07840846
Study groupRoleWhat they receive
Standardized Large Yellow Tea Extract GroupExperimentalParticipants will receive standardized large yellow tea extract for 12 weeks together with standardized lifestyle guidance.
Receives: Dietary Supplement: Standardized Large Yellow Tea Extract
Placebo Control GroupPlacebo comparatorParticipants will receive a matching placebo for 12 weeks together with standardized lifestyle guidance.
Receives: Dietary Supplement: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change From Baseline in Fasting Triglyceride Level at Week 12

    Fasting serum triglyceride concentration will be measured at baseline and Week 12. The outcome will be calculated as the Week 12 value minus the baseline value and compared between the standardized large yellow tea extract group and the placebo control group.

    Measured: Baseline and Week 12

Secondary outcomes (20)
  1. Change From Baseline in Total Cholesterol at Week 12

    Measured: Baseline and Week 12

  2. Change From Baseline in Apolipoprotein A1 at Week 12

    Measured: Baseline and Week 12

  3. Change From Baseline in Apolipoprotein B at Week 12

    Measured: Baseline and Week 12

  4. Change From Baseline in Body Mass Index at Week 12

    Measured: Baseline and Week 12

  5. Change From Baseline in Low-Density Lipoprotein Cholesterol at Week 12

    Low-density lipoprotein cholesterol (LDL-C) will be measured at baseline and Week 12. Change from baseline will be calculated as the Week 12 value minus the baseline value.

    Measured: Baseline and Week 12

  6. Number of Participants With Adverse Events

    Measured: Baseline through Week 24

  7. Change From Baseline in High-Density Lipoprotein Cholesterol at Week 12

    High-density lipoprotein cholesterol (HDL-C) will be measured at baseline and Week 12. Change from baseline will be calculated as the Week 12 value minus the baseline value.

    Measured: Baseline and Week 12

  8. Change From Baseline in Non-High-Density Lipoprotein Cholesterol at Week 12

    Non-high-density lipoprotein cholesterol (non-HDL-C) will be calculated as total cholesterol minus HDL-C at baseline and Week 12. Change from baseline will be calculated as the Week 12 value minus the baseline value

    Measured: Baseline and Week 12

  9. Change From Baseline in Small Dense Low-Density Lipoprotein Cholesterol at Week 12

    Small dense low-density lipoprotein cholesterol (sdLDL-C) will be measured at baseline and Week 12. Change from baseline will be calculated as the Week 12 value minus the baseline value.

    Measured: Baseline and Week 12

  10. Change From Baseline in Fasting Plasma Glucose at Week 12

    Fasting plasma glucose will be measured at baseline and Week 12. Change from baseline will be calculated as the Week 12 value minus the baseline value.

    Measured: Baseline and Week 12

  11. Change From Baseline in Fasting Insulin at Week 12

    Fasting insulin will be measured at baseline and Week 12. Change from baseline will be calculated as the Week 12 value minus the baseline value.

    Measured: Baseline and Week 12

  12. Change From Baseline in HOMA-IR at Week 12

    Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) will be calculated from fasting plasma glucose and fasting insulin measured at baseline and Week 12. Change from baseline will be calculated as the Week 12 value minus the baseline value.

    Measured: Baseline and Week 12

  13. Change From Baseline in Body Weight at Week 12

    Body weight will be measured at baseline and Week 12. Change from baseline will be calculated as the Week 12 value minus the baseline value.

    Measured: Baseline and Week 12

  14. Change From Baseline in Waist Circumference at Week 12

    Waist circumference will be measured at baseline and Week 12. Change from baseline will be calculated as the Week 12 value minus the baseline value.

    Measured: Baseline and Week 12

  15. Change From Baseline in Systolic Blood Pressure at Week 12

    Systolic blood pressure will be measured at baseline and Week 12. Change from baseline will be calculated as the Week 12 value minus the baseline value.

    Measured: Baseline and Week 12

  16. Change From Baseline in Diastolic Blood Pressure at Week 12

    Diastolic blood pressure will be measured at baseline and Week 12. Change from baseline will be calculated as the Week 12 value minus the baseline value.

    Measured: Baseline and Week 12

  17. Change From Baseline in Heart Rate at Week 12

    Heart rate will be measured at baseline and Week 12. Change from baseline will be calculated as the Week 12 value minus the baseline value.

    Measured: Baseline and Week 12

  18. Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 12

    Glycated hemoglobin (HbA1c) will be measured at baseline and Week 12. Change from baseline will be calculated as the Week 12 value minus the baseline value.

    Measured: Baseline and Week 12

  19. Change From Baseline in Body Fat Percentage at Week 12

    Body fat percentage will be measured using the prespecified body composition assessment method at baseline and Week 12. Change from baseline will be calculated as the Week 12 value minus the baseline value.

    Measured: Baseline and Week 12

  20. Change From Baseline in Visceral Fat at Week 12

    Visceral fat will be assessed using the prespecified body composition assessment method at baseline and Week 12. Change from baseline will be calculated as the Week 12 value minus the baseline value.

    Measured: Baseline and Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Sep 2026
  2. Study startSep 2026 (estimated)
  3. Primary completionDec 2027 (estimated)
  4. Study completionMar 2028 (estimated)

Resources

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
Parallel groups
Model description
Participants will be randomized in a 1:2 ratio to a placebo control group or a standardized large yellow tea extract group and will receive the assigned intervention for 12 weeks. Randomization may be stratified by study center.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
138 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07840846
Sponsor's protocol ID
2026-ky291
Other IDs
KCXFZJ-DDBF-202501, 2023STY02
Status last verified
Sep 2026
First submitted
11 Sep 2026
Last updated
25 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Standardized Large Yellow Tea Extract in people with Hypertriglyceridemia and Overweight , Obesity, 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 9 inclusion and 14 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 25 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. Some participants in this study may receive a placebo. 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?

Change From Baseline in Fasting Triglyceride Level at Week 12 (time frame: Baseline and Week 12). 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 25 Sep 2026.

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