Tea Extract, Blood Lipid and Dietary Fat

NCT03324191 | Completed

• 1 other identifier: HVS-009
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Lipid Metabolism; Diabetes

Keywords

Tea extract; Triglycerides; Energy metabolism

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (17)

• Effect of tea extract on systemic glucose concentration following a high fat meal

  3 hour postprandial period

• Effect of tea extract on systemic insulin concentration following a high fat meal

  3 hour postprandial period

• Effect of tea extract on systemic C-peptide concentration following a high fat meal

  3 hour postprandial period

• Effect of tea extract on systemic non-esterified fatty acid concentration following a high fat meal

  3 hour postprandial period

• Effect of tea extract on systemic high density lipoprotein concentration following a high fat meal

  3 hour postprandial period

Study Arms (4)

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.

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.

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.

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.

Dietary Supplement: Tea extract (high concentration); Other: High fat liquid meal challenge

Interventions

Placebo DIETARY_SUPPLEMENT

Placebo will be matched for flavour, odour, and colour, to a tea beverage, without any active ingredient (tea extract).

Placebo

Tea beverage DIETARY_SUPPLEMENT

Tea beverage

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 (medium concentration)

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.

Tea extract (high concentration)

High fat liquid meal challenge OTHER

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.

Placebo; Tea beverage; Tea extract (high concentration); Tea extract (medium concentration)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Bath: lead
• Lucozade Ribena Suntory: collaborator

Study Sites (1)

University of Bath

Bath, Avon, BA2 7AY, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 37080462 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Tea

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Plant Preparations; Biological Products; Complex Mixtures; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• James Betts, PhD

  University of Bath

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Participants and Researchers will be blinded to the interventions.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Model Details: Double-blind, single-centre randomised controlled trial using a cross-over experimental design.

Study Record Dates

• First Submitted: October 19, 2017
• First Posted: October 27, 2017
• Study Start: October 10, 2017
• Primary Completion: March 7, 2018
• Study Completion: September 30, 2018
• Last Updated: April 18, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)