Lipid MetabolismNCT03324191
Tea Extract, Blood Lipid and Dietary Fat
A study testing Tea beverage, Tea extract (medium concentration) and Tea extract (high concentration) in people with Lipid Metabolism and Diabetes, run by University of Bath at 1 site in United Kingdom.
Trial summary
There are numerous factors known to determine the relative rate of lipid metabolism at rest between and within individuals, including: biological sex, endogenous carbohydrate availability, training status and, in particular, feeding. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Lipid Metabolism, Diabetes
- What is being tested?
- Tea beverage, Tea extract (medium concentration) and Tea extract (high concentration)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 10 Oct 2017to 30 Sep 2018
- 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Consent- Demonstrates understanding of the study and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form.
- Age- Aged between 18 and 60 years.
- Compliance- Understands and is willing, able and likely to comply with all study procedures and restrictions.
- General Health - Good general and mental health with, in the opinion of the investigator or medically qualified designee:
- No clinically significant and relevant abnormalities of medical history or physical examination.
- Absence of any condition that would impact on the subject's safety or wellbeing or affect the individual's ability to understand and follow study procedures and requirements.
- No anticipated changes in diet and/or physical activity or lifestyle habits during the study period (e.g. pre-planned holidays, diets/exercise plan, smoking etc.)
- Contraception- Females of childbearing potential who are, in the opinion of the investigator, practising a reliable method of contraception. Adequate contraception is defined as abstinence, oral contraceptive, either combined or progestogen alone OR injectable progestogen OR implants of levonorgestrel OR estrogenic vaginal ring OR percutaneous contraceptive patches OR intrauterine device or intrauterine system OR double barrier method (condom or occlusive cap [diaphragm or cervical vault caps] plus spermicidal agent [foam, gel, film, cream, suppository]) OR male partner sterilization prior to the female subject's entry into the study, and this male is the sole partner for that subject.
Who cannot join
- Pregnancy- Women who are known to be pregnant or who are intending to become pregnant over the duration of the study.
- Breast-feeding- Women who are breast-feeding.
- Allergy/Intolerance- Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.
- Blood donation- More than 400ml of blood within 3 months of the screening visit and more than 1500ml of blood in the previous 12 months. Any reported bleeding disorder
- Clinical Study/Experimental Medication
- Participation in another clinical study or receipt of an investigational drug within 90 days of the screening visit) to allow full recovery of blood volume
Show all 11Show fewer
- Previous participation in this study.
- Any reported recent (within 6 months) shift (>3 kg) in body mass
- Substance abuse- Recent history (within the last 2 years) of alcohol or other substance abuse and / or Any reported use of substances which may pose undue personal risk to participants or introduce bias into the experiment as deemed by the Principal Investigator
- Any reported condition or behaviour deemed by the Principal Investigator either to pose undue personal risk to the participant or introduce bias into the experiment
- Exclusion criteria assessed after taking measurements- Those with body mass index < 18 or > 35 kg/m^2. Medical history of diabetes.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of a Polyphenol-rich Tea Extract on Blood Lipid Response to Dietary Fat
There are numerous factors known to determine the relative rate of lipid metabolism at rest between and within individuals, including: biological sex, endogenous carbohydrate availability, training status and, in particular, feeding. Recent focus has been placed on the potential of alternative nutrients, nutritional supplements and pharmacological agents to modify substrate selection in favour of greater lipid oxidation (e.g. caffeine, carnitine, green tea) and/or to alter lipid absorption (e.g. caffeine, carnitine, orlistat, green tea preparations).
Polyphenol-rich tea extract can have effects on lipase activity in the pancreas causing reduced fat absorption. The present study is to assess the potential for tea extract alone to be as effective at the liquid product in a western population.
Read the detailed description
Participants will be asked to visit laboratories at the University of Bath on four occasions, with each visit separated by at least 2 days. Each visit will last approximately 5 hours.
Participants will be asked to provide informed consent to participate in the study and to answer a number of questions to confirm that it is safe for them to do so, and to confirm eligibility. Participants will be asked to monitor their diet for 48 h before their first laboratory visit, and then to replicate this diet before subsequent visits. Participants will also be asked abstain from caffeine (i.e tea and coffee), alcohol and strenuous physical activity the day before visiting us (e.g. no exercise that causing sweating or heavy breathing).
Participants will be asked to arrive to the laboratory after having not eaten for at least 5 hours, having drunk one pint of water at least one hour before testing. Upon arrival at the laboratory a person trained and experienced in sampling blood will insert a cannula (a small plastic tube) into a vein on the participants arm. This is to allow for repeated blood sampling every 30-60 minutes during their visit.
Participants will then be provided with one of the four supplements under investigation (i.e. either a placebo or one of the preparations derived from tea) to ingest as fluid along with a standard milkshake that provides participants with 40 g of fat, such that the appearance of this fat in the bloodstream can be measured. Of the 55 participants in this study, additional measurements will be made on a randomly selected sub-group of 15 to directly trace the appearance of fat in their blood samples; if participants have been asked and agreed to this part of the study then some of the fat in their milkshake would be a stable isotope tracer (13C-Tripalmitin). Participants will then rest comfortably, and a 10 ml sample of blood will be drawn from participants every 30 minutes for two hours, and at three hours, after consumption of the high fat drink.
- Conditions
- Lipid Metabolism, Diabetes
- Being tested
- Placebo, Tea beverage, Tea extract (medium concentration), Tea extract (high concentration), High fat liquid meal challenge
- Keywords
- Tea extract, Triglycerides, Energy metabolism
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDietary supplement
Placebo will be matched for flavour, odour, and colour, to a tea beverage, without any active ingredient (tea extract).
Tea beverageDietary supplement
Tea beverage
Tea extract (medium concentration)Dietary supplement
Tea extract (medium concentration) will be matched for flavour, odour, and colour, to a tea beverage, with a medium concentration of tea extract.
Tea extract (high concentration)Dietary supplement
Tea extract (medium concentration) will be matched for flavour, odour, and colour, to a tea beverage, with a high concentration of tea extract.
High fat liquid meal challengeOther
A dairy based standard study meal challenge providing 40 g dietary fat and less than 2 g carbohydrate or 1.2 g protein.
For the tracer test subpopulation (n=15) the test meal will also contain 300 mg [1,1,1-13C3] tripalmitin to trace the incorporation of dietary lipid into plasma fatty acids.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Participants will consume 567 ml of plain water at least 1 hour before testing the trial.
Information on dietary compliance will be collected. Participants will then be cannulated in an arm vein and a baseline fasting blood sample will be taken. Participants will be asked to consume a standard study meal challenge (providing 40 g dietary fat and less than 2 g carbohydrate or 1.2 g protein) and placebo drink within 15 min. Serial blood samples will be collected at baseline, 30, 60, 90, 120 and 180 min. The intervention will end once the 180 min sample is collected.
For the tracer test subpopulation (n=15) the test meal will also contain 300 mg [1,1,1-13C3] tripalmitin to trace the incorporation of dietary lipid into plasma fatty acids. Receives: Dietary Supplement: Placebo; Other: High fat liquid meal challenge |
| Tea beverage | Experimental | Participants will consume 567 ml of plain water at least 1 hour before testing the trial.
Information on dietary compliance will be collected. Participants will then be cannulated in an arm vein and a baseline fasting blood sample will be taken. Participants will be asked to consume a standard study meal challenge (providing 40 g dietary fat and less than 2 g carbohydrate or 1.2 g protein) and tea within 15 min. Serial blood samples will be collected at baseline, 30, 60, 90, 120 and 180 min. The intervention will end once the 180 min sample is collected.
For the tracer test subpopulation (n=15) the test meal will also contain 300 mg [1,1,1-13C3] tripalmitin to trace the incorporation of dietary lipid into plasma fatty acids. Receives: Dietary Supplement: Tea beverage; Other: High fat liquid meal challenge |
| Tea extract (medium concentration) | Experimental | Participants will consume 567 ml of plain water at least 1 hour before testing the trial.
Information on dietary compliance will be collected. Participants will then be cannulated in an arm vein and a baseline fasting blood sample will be taken. Participants will be asked to consume a standard study meal challenge (providing 40 g dietary fat and less than 2 g carbohydrate or 1.2 g protein) and concentrated tea extract at a medium concentration within 15 min. Serial blood samples will be collected at baseline, 30, 60, 90, 120 and 180 min. The intervention will end once the 180 min sample is collected.
For the tracer test subpopulation (n=15) the test meal will also contain 300 mg [1,1,1-13C3] tripalmitin to trace the incorporation of dietary lipid into plasma fatty acids. Receives: Dietary Supplement: Tea extract (medium concentration); Other: High fat liquid meal challenge |
| Tea extract (high concentration) | Experimental | Participants will consume 567 ml of plain water at least 1 hour before testing the trial.
Information on dietary compliance will be collected. Participants will then be cannulated in an arm vein and a baseline fasting blood sample will be taken. Participants will be asked to consume a standard study meal challenge (providing 40 g dietary fat and less than 2 g carbohydrate or 1.2 g protein) and concentrated tea extract at a high concentration within 15 min. Serial blood samples will be collected at baseline, 30, 60, 90, 120 and 180 min. The intervention will end once the 180 min sample is collected.
For the tracer test subpopulation (n=15) the test meal will also contain 300 mg [1,1,1-13C3] tripalmitin to trace the incorporation of dietary lipid into plasma fatty acids. Receives: Dietary Supplement: Tea extract (high concentration); Other: High fat liquid meal challenge |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of tea extract on serum triacylglycerol concentration following a high fat meal
Comparison of tea extract to placebo and positive controls
Measured: 3 hour postprandial period
Secondary outcomes (17)
Effect of tea extract on systemic glucose concentration following a high fat meal
Comparison of tea extract to placebo and positive controls
Measured: 3 hour postprandial period
Effect of tea extract on systemic insulin concentration following a high fat meal
Comparison of tea extract to placebo and positive controls
Measured: 3 hour postprandial period
Effect of tea extract on systemic C-peptide concentration following a high fat meal
Comparison of tea extract to placebo and positive controls
Measured: 3 hour postprandial period
Effect of tea extract on systemic non-esterified fatty acid concentration following a high fat meal
Comparison of tea extract to placebo and positive controls
Measured: 3 hour postprandial period
Effect of tea extract on systemic high density lipoprotein concentration following a high fat meal
Comparison of tea extract to placebo and positive controls
Measured: 3 hour postprandial period
Effect of tea extract on systemic low density lipoprotein concentration following a high fat meal
Comparison of tea extract to placebo and positive controls
Measured: 3 hour postprandial period
Effect of tea extract on systemic glycerol concentration following a high fat meal
Comparison of tea extract to placebo and positive controls
Measured: 3 hour postprandial period
Effect of tea extract on systemic apolipoprotein A1 concentration following a high fat meal
Comparison of tea extract to placebo and positive controls
Measured: 3 hour postprandial period
Effect of tea extract on systemic apolipoprotein A2 concentration following a high fat meal
Comparison of tea extract to placebo and positive controls
Measured: 3 hour postprandial period
Effect of tea extract on systemic apolipoprotein B concentration following a high fat meal
Comparison of tea extract to placebo and positive controls
Measured: 3 hour postprandial period
Effect of tea extract on systemic apolipoprotein C2 concentration following a high fat meal
Comparison of tea extract to placebo and positive controls
Measured: 3 hour postprandial period
Effect of tea extract on systemic apolipoprotein C3 concentration following a high fat meal
Comparison of tea extract to placebo and positive controls
Measured: 3 hour postprandial period
Effect of tea extract on systemic apolipoprotein E concentration following a high fat meal
Comparison of tea extract to placebo and positive controls
Measured: 3 hour postprandial period
Effect of tea extract on plasma triacylglycerol concentration following a high fat meal
Comparison of tea extract to placebo and positive controls
Measured: 3 hour postprandial period
Effect of tea extract on the incorporation of dietary fats into systemic triacylglycerol following a high fat meal
Comparison of tea extract to placebo and positive controls in a sub-population of 15 randomly selected participants.
Measured: 3 hour postprandial period
Effect of tea extract on the incorporation of dietary fats into non-esterified fatty acids following a high fat meal
Comparison of tea extract to placebo and positive controls in a sub-population of 15 randomly selected participants.
Measured: 3 hour postprandial period
Effect of tea extract on whole body lipid oxidation following a high fat meal
Comparison of tea extract to placebo and positive controls in a sub-population of 15 randomly selected participants.
Measured: 3 hour postprandial period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2017
- Study start10 Oct 2017
- Primary completion7 Mar 2018
- Study completion30 Sep 2018
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 Lipid MetabolismStudies 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
- Double-blind, single-centre randomised controlled trial using a cross-over experimental design.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bath
- Sponsor type
- University, hospital or other
- Collaborators
- Lucozade Ribena Suntory
- Responsible party
- Principal investigator, James Betts, University of Bath
- Investigators
- James Betts, PhD, Principal investigator, University of Bath
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03324191
- Sponsor's protocol ID
- HVS-009
- Status last verified
- Apr 2023
- First submitted
- 19 Oct 2017
- Last updated
- 18 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Perkin OJ, Chen YC, Johnson DA, Thomas JE, Atkinson G, Betts JA, Gonzalez JT. Postprandial Metabolic Mesponses to High-fat Feeding in Healthy Adults Following Ingestion of Oolong Tea-Derived Polymerized Polyphenols: A Randomized, Double-blinded, Placebo-controlled Crossover Study. Am J Clin Nutr. 2023 Jul;118(1):132-140. doi: 10.1016/j.ajcnut.2023.04.020. Epub 2023 Apr 18.
PubMed 37080462
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Polyphenol-rich Tea Extract on Blood Lipid Response to Dietary Fat
- ClinicalTrials.gov ID
- NCT03324191
- Acronym / sponsor ID
- HVS-009
- Conditions
- Lipid Metabolism, Diabetes
- Keywords
- Tea extract, Triglycerides, Energy metabolism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- University of BathUniversity, hospital or other
- Collaborators
- Lucozade Ribena Suntory
- Study start
- 10 Oct 2017 (actual)
- Primary completion
- 7 Mar 2018 (actual)
- Study completion
- 30 Sep 2018 (actual)
- First posted
- 27 Oct 2017 (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.
There are numerous factors known to determine the relative rate of lipid metabolism at rest between and within individuals, including: biological sex, endogenous carbohydrate availability, training status and, in particular, feeding. Recent focus has been placed on the potential of alternative nutrients, nutritional supplements and pharmacological agents to modify substrate selection in favour of greater lipid oxidation (e.g. caffeine, carnitine, green tea) and/or to alter lipid absorption (e.g. caffeine, carnitine, orlistat, green tea preparations).
Polyphenol-rich tea extract can have effects on lipase activity in the pancreas causing reduced fat absorption. The present study is to assess the potential for tea extract alone to be as effective at the liquid product in a western population.
Detailed description
Participants will be asked to visit laboratories at the University of Bath on four occasions, with each visit separated by at least 2 days. Each visit will last approximately 5 hours.
Participants will be asked to provide informed consent to participate in the study and to answer a number of questions to confirm that it is safe for them to do so, and to confirm eligibility. Participants will be asked to monitor their diet for 48 h before their first laboratory visit, and then to replicate this diet before subsequent visits. Participants will also be asked abstain from caffeine (i.e tea and coffee), alcohol and strenuous physical activity the day before visiting us (e.g. no exercise that causing sweating or heavy breathing).
Participants will be asked to arrive to the laboratory after having not eaten for at least 5 hours, having drunk one pint of water at least one hour before testing. Upon arrival at the laboratory a person trained and experienced in sampling blood will insert a cannula (a small plastic tube) into a vein on the participants arm. This is to allow for repeated blood sampling every 30-60 minutes during their visit.
Participants will then be provided with one of the four supplements under investigation (i.e. either a placebo or one of the preparations derived from tea) to ingest as fluid along with a standard milkshake that provides participants with 40 g of fat, such that the appearance of this fat in the bloodstream can be measured. Of the 55 participants in this study, additional measurements will be made on a randomly selected sub-group of 15 to directly trace the appearance of fat in their blood samples; if participants have been asked and agreed to this part of the study then some of the fat in their milkshake would be a stable isotope tracer (13C-Tripalmitin). Participants will then rest comfortably, and a 10 ml sample of blood will be drawn from participants every 30 minutes for two hours, and at three hours, after consumption of the high fat drink.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
- Model description
- Double-blind, single-centre randomised controlled trial using a cross-over experimental design.
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: Placebo, Other: High fat liquid meal challengeParticipants will consume 567 ml of plain water at least 1 hour before testing the trial. Information on dietary compliance will be collected. Participants will then be cannulated in an arm vein and a baseline fasting blood sample will be taken. Participants will be asked to consume a standard study meal challenge (providing 40 g dietary fat and less than 2 g carbohydrate or 1.2 g protein) and placebo drink within 15 min. Serial blood samples will be collected at baseline, 30, 60, 90, 120 and 180 min. The intervention will end once the 180 min sample is collected. For the tracer test subpopulation (n=15) the test meal will also contain 300 mg [1,1,1-13C3] tripalmitin to trace the incorporation of dietary lipid into plasma fatty acids. |
| Tea beverage | Experimental | Dietary Supplement: Tea beverage, Other: High fat liquid meal challengeParticipants will consume 567 ml of plain water at least 1 hour before testing the trial. Information on dietary compliance will be collected. Participants will then be cannulated in an arm vein and a baseline fasting blood sample will be taken. Participants will be asked to consume a standard study meal challenge (providing 40 g dietary fat and less than 2 g carbohydrate or 1.2 g protein) and tea within 15 min. Serial blood samples will be collected at baseline, 30, 60, 90, 120 and 180 min. The intervention will end once the 180 min sample is collected. For the tracer test subpopulation (n=15) the test meal will also contain 300 mg [1,1,1-13C3] tripalmitin to trace the incorporation of dietary lipid into plasma fatty acids. |
| Tea extract (medium concentration) | Experimental | Dietary Supplement: Tea extract (medium concentration), Other: High fat liquid meal challengeParticipants will consume 567 ml of plain water at least 1 hour before testing the trial. Information on dietary compliance will be collected. Participants will then be cannulated in an arm vein and a baseline fasting blood sample will be taken. Participants will be asked to consume a standard study meal challenge (providing 40 g dietary fat and less than 2 g carbohydrate or 1.2 g protein) and concentrated tea extract at a medium concentration within 15 min. Serial blood samples will be collected at baseline, 30, 60, 90, 120 and 180 min. The intervention will end once the 180 min sample is collected. For the tracer test subpopulation (n=15) the test meal will also contain 300 mg [1,1,1-13C3] tripalmitin to trace the incorporation of dietary lipid into plasma fatty acids. |
| Tea extract (high concentration) | Experimental | Dietary Supplement: Tea extract (high concentration), Other: High fat liquid meal challengeParticipants will consume 567 ml of plain water at least 1 hour before testing the trial. Information on dietary compliance will be collected. Participants will then be cannulated in an arm vein and a baseline fasting blood sample will be taken. Participants will be asked to consume a standard study meal challenge (providing 40 g dietary fat and less than 2 g carbohydrate or 1.2 g protein) and concentrated tea extract at a high concentration within 15 min. Serial blood samples will be collected at baseline, 30, 60, 90, 120 and 180 min. The intervention will end once the 180 min sample is collected. For the tracer test subpopulation (n=15) the test meal will also contain 300 mg [1,1,1-13C3] tripalmitin to trace the incorporation of dietary lipid into plasma fatty acids. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Consent- Demonstrates understanding of the study and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form.
- Age- Aged between 18 and 60 years.
- Compliance- Understands and is willing, able and likely to comply with all study procedures and restrictions.
- General Health - Good general and mental health with, in the opinion of the investigator or medically qualified designee:
- No anticipated changes in diet and/or physical activity or lifestyle habits during the study period (e.g. pre-planned holidays, diets/exercise plan, smoking etc.)
Key exclusion criteria (11 listed)
- Pregnancy- Women who are known to be pregnant or who are intending to become pregnant over the duration of the study.
- Breast-feeding- Women who are breast-feeding.
- Allergy/Intolerance- Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.
- Blood donation- More than 400ml of blood within 3 months of the screening visit and more than 1500ml of blood in the previous 12 months. Any reported bleeding disorder
- Clinical Study/Experimental Medication
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 |
|---|---|---|
| PlaceboPlacebo will be matched for flavour, odour, and colour, to a tea beverage, without any active ingredient (tea extract). | Dietary supplement | Placebo |
| Tea beverageTea beverage | Dietary supplement | Tea beverage |
| Tea extract (medium concentration)Tea extract (medium concentration) will be matched for flavour, odour, and colour, to a tea beverage, with a medium concentration of tea extract. | Dietary supplement | Tea extract (medium concentration) |
| Tea extract (high concentration)Tea extract (medium concentration) will be matched for flavour, odour, and colour, to a tea beverage, with a high concentration of tea extract. | Dietary supplement | Tea extract (high concentration) |
| High fat liquid meal challengeA dairy based standard study meal challenge providing 40 g dietary fat and less than 2 g carbohydrate or 1.2 g protein. For the tracer test subpopulation (n=15) the test meal will also contain 300 mg [1,1,1-13C3] tripalmitin to trace the incorporation of dietary lipid into plasma fatty acids. | Other | Placebo, Tea beverage, Tea extract (high concentration), Tea extract (medium concentration) |
Primary outcome
Effect of tea extract on serum triacylglycerol concentration following a high fat meal
Time frame: 3 hour postprandial period
Comparison of tea extract to placebo and positive controls
17 secondary outcomes
Effect of tea extract on systemic glucose concentration following a high fat meal
Time frame: 3 hour postprandial period
Effect of tea extract on systemic insulin concentration following a high fat meal
Time frame: 3 hour postprandial period
Effect of tea extract on systemic C-peptide concentration following a high fat meal
Time frame: 3 hour postprandial period
Effect of tea extract on systemic non-esterified fatty acid concentration following a high fat meal
Time frame: 3 hour postprandial period
Effect of tea extract on systemic high density lipoprotein concentration following a high fat meal
Time frame: 3 hour postprandial period
Effect of tea extract on systemic low density lipoprotein concentration following a high fat meal
Time frame: 3 hour postprandial period
Effect of tea extract on systemic glycerol concentration following a high fat meal
Time frame: 3 hour postprandial period
Effect of tea extract on systemic apolipoprotein A1 concentration following a high fat meal
Time frame: 3 hour postprandial period
Effect of tea extract on systemic apolipoprotein A2 concentration following a high fat meal
Time frame: 3 hour postprandial period
Effect of tea extract on systemic apolipoprotein B concentration following a high fat meal
Time frame: 3 hour postprandial period
Effect of tea extract on systemic apolipoprotein C2 concentration following a high fat meal
Time frame: 3 hour postprandial period
Effect of tea extract on systemic apolipoprotein C3 concentration following a high fat meal
Time frame: 3 hour postprandial period
Effect of tea extract on systemic apolipoprotein E concentration following a high fat meal
Time frame: 3 hour postprandial period
Effect of tea extract on plasma triacylglycerol concentration following a high fat meal
Time frame: 3 hour postprandial period
Effect of tea extract on the incorporation of dietary fats into systemic triacylglycerol following a high fat meal
Time frame: 3 hour postprandial period
Effect of tea extract on the incorporation of dietary fats into non-esterified fatty acids following a high fat meal
Time frame: 3 hour postprandial period
Effect of tea extract on whole body lipid oxidation following a high fat meal
Time frame: 3 hour postprandial period
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 18 Apr 2023.
- Derived from this study: PubMed 37080462Perkin OJ, Chen YC, Johnson DA, Thomas JE, Atkinson G, Betts JA, Gonzalez JT. Postprandial Metabolic Mesponses to High-fat Feeding in Healthy Adults Following Ingestion of Oolong Tea-Derived Polymerized Polyphenols: A Randomized, Double-blinded, Placebo-controlled Crossover Study. Am J Clin Nutr. 2023 Jul;118(1):132-140. doi: 10.1016/j.ajcnut.2023.04.020. Epub 2023 Apr 18.
- 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.
James Betts, PhD principal investigator
University of Bath
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tea beverage, Tea extract (medium concentration) and Tea extract (high concentration) in people with Lipid Metabolism and Diabetes, run by University of Bath at 1 site in United Kingdom.
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 8 inclusion and 11 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 18 Apr 2023. 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 United Kingdom. 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. 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?
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?
Effect of tea extract on serum triacylglycerol concentration following a high fat meal (time frame: 3 hour postprandial period). 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 NCT03324191, 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 18 Apr 2023.