An interventional study of Placebo and Tea beverage in Lipid Metabolism and Diabetes, sponsored by University of Bath. Completed at 1 site in United Kingdom. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-04-18.
Sponsored by University of Bath · Not applicable, Interventional, and Basic science
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Among 462 studies in Diabetes Mellitus with a site in United Kingdom — 29 open to participants now, 48 under way, 5 of them phase 3. Diabetes Mellitus · United Kingdom.
Among the 462 studies in Diabetes Mellitus with a site in United Kingdom, this one is the 239th largest by enrollment of the 364 interventional ones that give a count, is one of 27 that started in 2017, is one of 137 with no phase, and was the 324th registered.
8,292 studies on the registry are indexed under Diabetes Mellitus; 1,074 are open to participants now.
Browse Diabetes Mellitus studies →29 of the 462 studies in Diabetes Mellitus with a site in United Kingdom are open now. Recruiting first, the newest first:
Imperial College London · Sites in United Kingdom
Ages 18+
University of Exeter · Sites in United Kingdom
Ages 6–99 · Healthy volunteers
Tameside General Hospital · Sites in United Kingdom
Ages 18+
Imperial College London · Sites in United Kingdom
Ages 18–70
Royal Devon and Exeter NHS Foundation Trust · Sites in United Kingdom
Ages 18+
A study can be open while its sites in United Kingdom have not opened yet or have stopped. Only those recruiting at a site in United Kingdom →
Of the 650 Diabetes Mellitus studies recruiting now, 357 (55%) set no upper age limit and 197 (30%) stop at 75 or younger; 88 take children under 18; 183 take healthy volunteers.
This study: 18 Years to 60 Years · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
462 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 42 · Phase 2 55 · Phase 3 104 · Phase 4 40
First in 1994; this study’s year is marked. 27 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 52 is below the median of 80 across 6,024 interventional studies indexed under Diabetes Mellitus.
Median enrollment 120 across the 364 interventional studies, 600 across the 97 observational. Of the 365 that completed or were terminated, 120 (33%) have results posted.
This tab as a report to print or save as PDF → With an account.
242 of 462 have an industry lead sponsor. The 10 most frequent:
University of Bath is the lead sponsor of 94 studies on the registry; 20 are open to participants now.
University of Bath has 4 studies filed under Diabetes Mellitus — fewer than ten, so there is no comparison to draw.
10 of the studies in Diabetes Mellitus with a site in United Kingdom that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07400653Phase 3PfizerA Study to Learn About the Study Medicine (PF-08653944) in People With Obesity or Overweight and Type 2 Diabetes (T2D) | 2027-10-12 |
| NCT05762432Community Pharmacology Services LtdDiabetic Foot Ulcer Research Study | 2026-12-01 |
| NCT06463483Imperial College LondonAutomated Insulin Delivery in Adults With Advanced Kidney Disease | 2026-12-30 |
| NCT06695325Tameside General HospitalConvenient Home Access for Routine Monitoring in Diabetes (Charm-D Study) | 2026-12-31 |
| NCT06782568Imperial College LondonAvoidance of Insulin-induced Lipohypertophy in People With Diabetes Using Ultrasound Scanning Within Diabetes Clinics | 2026-12-31 |
Add all 10 to your calendar (.ics) → With an account.
Among the 462 studies in Diabetes Mellitus with a site in United Kingdom, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
General Health - Good general and mental health with, in the opinion of the investigator or medically qualified designee:
Exclusion Criteria:
Clinical Study/Experimental Medication
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Dietary Supplement: Placebo · Other: High fat liquid meal challenge
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.
Dietary Supplement: Tea beverage · Other: High fat liquid meal challenge
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.
Dietary Supplement: Tea extract (medium concentration) · Other: High fat liquid meal challenge
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.
Dietary Supplement: Tea extract (high concentration) · Other: High fat liquid meal challenge
Placebo will be matched for flavour, odour, and colour, to a tea beverage, without any active ingredient (tea extract).
Tea beverage
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 (medium concentration) will be matched for flavour, odour, and colour, to a tea beverage, with a high concentration of tea extract.
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.
Effect of tea extract on serum triacylglycerol concentration following a high fat meal
Comparison of tea extract to placebo and positive controls
Time frame: 3 hour postprandial period
Effect of tea extract on systemic glucose concentration following a high fat meal
Comparison of tea extract to placebo and positive controls
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
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
Comparison of tea extract to placebo and positive controls in a sub-population of 15 randomly selected participants.
Time frame: 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.
Time frame: 3 hour postprandial period
Plan to share: No
No publications or documents are linked to this record.
Ran from Oct 2017 to primary completion in Mar 2018, 4 months.
Of 1,586 non-industry interventional studies with no phase under Diabetes Mellitus, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 43. This study's 4 months is below that.
Counting every sponsor, half of 1,746 studies reached it within 21 months; a quarter within 9 and three quarters within 42.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Tea
University of Bath