Status:
COMPLETED
Tea Extract, Blood Lipid and Dietary Fat
Lead Sponsor:
University of Bath
Collaborating Sponsors:
Lucozade Ribena Suntory
Conditions:
Lipid Metabolism
Diabetes
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief 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 st...
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 wi...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
- 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.
Key Trial Info
Start Date :
October 10 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2018
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT03324191
Start Date
October 10 2017
End Date
September 30 2018
Last Update
April 18 2023
Active Locations (1)
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1
University of Bath
Bath, Avon, United Kingdom, BA2 7AY