Diabetes Clinical Trial
Official title:
Effect of a Polyphenol-rich Tea Extract on Blood Lipid Response to Dietary Fat
Verified date | April 2023 |
Source | University of Bath |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 52 |
Est. completion date | September 30, 2018 |
Est. primary completion date | March 7, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility | Inclusion Criteria: 1. 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. 2. Age- Aged between 18 and 60 years. 3. Compliance- Understands and is willing, able and likely to comply with all study procedures and restrictions. 4. General Health - Good general and mental health with, in the opinion of the investigator or medically qualified designee: 1. No clinically significant and relevant abnormalities of medical history or physical examination. 2. 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. 5. 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.) 6. 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. Exclusion Criteria: 1. Pregnancy- Women who are known to be pregnant or who are intending to become pregnant over the duration of the study. 2. Breast-feeding- Women who are breast-feeding. 3. Allergy/Intolerance- Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients. 4. 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 5. Clinical Study/Experimental Medication 1. 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 2. Previous participation in this study. 6. Any reported recent (within 6 months) shift (>3 kg) in body mass 7. 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 8. 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 9. Exclusion criteria assessed after taking measurements- Those with body mass index < 18 or > 35 kg/m^2. Medical history of diabetes. |
Country | Name | City | State |
---|---|---|---|
United Kingdom | University of Bath | Bath | Avon |
Lead Sponsor | Collaborator |
---|---|
University of Bath | Lucozade Ribena Suntory |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Effect of tea extract on serum triacylglycerol concentration following a high fat meal | Comparison of tea extract to placebo and positive controls | 3 hour postprandial period | |
Secondary | Effect of tea extract on systemic glucose concentration following a high fat meal | Comparison of tea extract to placebo and positive controls | 3 hour postprandial period | |
Secondary | Effect of tea extract on systemic insulin concentration following a high fat meal | Comparison of tea extract to placebo and positive controls | 3 hour postprandial period | |
Secondary | Effect of tea extract on systemic C-peptide concentration following a high fat meal | Comparison of tea extract to placebo and positive controls | 3 hour postprandial period | |
Secondary | 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 | 3 hour postprandial period | |
Secondary | Effect of tea extract on systemic high density lipoprotein concentration following a high fat meal | Comparison of tea extract to placebo and positive controls | 3 hour postprandial period | |
Secondary | Effect of tea extract on systemic low density lipoprotein concentration following a high fat meal | Comparison of tea extract to placebo and positive controls | 3 hour postprandial period | |
Secondary | Effect of tea extract on systemic glycerol concentration following a high fat meal | Comparison of tea extract to placebo and positive controls | 3 hour postprandial period | |
Secondary | Effect of tea extract on systemic apolipoprotein A1 concentration following a high fat meal | Comparison of tea extract to placebo and positive controls | 3 hour postprandial period | |
Secondary | Effect of tea extract on systemic apolipoprotein A2 concentration following a high fat meal | Comparison of tea extract to placebo and positive controls | 3 hour postprandial period | |
Secondary | Effect of tea extract on systemic apolipoprotein B concentration following a high fat meal | Comparison of tea extract to placebo and positive controls | 3 hour postprandial period | |
Secondary | Effect of tea extract on systemic apolipoprotein C2 concentration following a high fat meal | Comparison of tea extract to placebo and positive controls | 3 hour postprandial period | |
Secondary | Effect of tea extract on systemic apolipoprotein C3 concentration following a high fat meal | Comparison of tea extract to placebo and positive controls | 3 hour postprandial period | |
Secondary | Effect of tea extract on systemic apolipoprotein E concentration following a high fat meal | Comparison of tea extract to placebo and positive controls | 3 hour postprandial period | |
Secondary | Effect of tea extract on plasma triacylglycerol concentration following a high fat meal | Comparison of tea extract to placebo and positive controls | 3 hour postprandial period | |
Secondary | 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. | 3 hour postprandial period | |
Secondary | 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. | 3 hour postprandial period | |
Secondary | 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. | 3 hour postprandial period |
Status | Clinical Trial | Phase | |
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