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Green Tea Supplementation, Fat Oxidation and Body Composition in Overweight Individuals (GreenTea)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04628624
Recruitment Status : Completed
First Posted : November 13, 2020
Last Update Posted : November 13, 2020
Sponsor:
Information provided by (Responsible Party):
Justin Roberts, Anglia Ruskin University

Brief Summary:

The purpose of this study is to investigate the effects of green tea extract (GTE) on fat oxidation, body composition and exercise performance in overweight individuals. The study will be conducted under laboratory conditions following an 8 week supplemental period. Participants will be required to attend the laboratory for a pre-screening/familiarisation trial followed by assessments at week 0 (baseline), week 2, 4 and 8. Across the intervention, participants will maintain habitual dietary intake and follow a prescribed exercise programme. Additionally participants will be randomised to either a placebo, green tea extract or GTE with antioxidant supplementation.

It is hypothesised that the addition of antioxidants with GTE will enhance fat oxidation in overweight individuals more than GTE or placebo. It is further hypothesised that such improvements in fat oxidation due to GTE will lead to improvements in both body composition variables and submaximal exercise performance (metabolic efficiency) in overweight, but otherwise healthy persons.


Condition or disease Intervention/treatment Phase
Overweight and Obesity Fat Burn Dietary Supplement: Placebo control Dietary Supplement: GTE 1 Dietary Supplement: GTE 2 Not Applicable

Detailed Description:

The health benefits of polyphenols found in green tea (GT), the unfermented leaves of the tea plant, Camellia sinensis, are of current scientific interest. These health benefits, in part, relate to the bioactive catechin polyphenol content of GT, of which (-)-epigallocatechin-3-gallate (EGCG) can account for between 50-80% of the total catechin content. GT catechins have been proposed to influence metabolic and thermogenic activities in the short term, leading to enhanced fat oxidation capacity, although this has been disputed.

Research investigating GT extracts (GTE) and exercise have produced conflicting results. Modest EGCG dosage in the short term (270 mg·d-1 EGCG for 6 days, and 68 mg·d-1 EGCG for 3 weeks) did not alter metabolic or performance variables in healthy or endurance trained volunteers. However, the inclusion of 100.5 mg·d-1 EGCG over a 10 week training period enhanced whole-body metabolic efficiency elsewhere. One confounding factor though is the use of caffeinated GTE in these studies. When decaffeinated GTE (dGTE) has been employed, 366 mg EGCG was found to acutely increase fat oxidation by 17%. Indeed a recent publication from our research group investigating the short term use of dGTE demonstrated positive changes in fat oxidation in healthy volunteers. However, less is known as to whether dGTE (or indeed combinations of dGTE with antioxidant nutrients which may improve GTE bioavailability) could provide similar results in overweight or sedentary individuals embarking on an exercise programme.

The aim of this research proposal is therefore to assess the impact of two GTE strategies on fat oxidation, cardiometabolic health, visceral fat reduction, and exercise performance in a healthy, but overweight cohort undertaking a standardised exercise training programme.

Research Questions:

Q1: Does regular consumption of dGTE favourably enhance fat oxidation and/or improve variables associated with cardiometabolic health and body composition in comparison to a placebo supplement in healthy, but overweight individuals? Q2: Does a dGTE complex (including key antioxidant nutrients) enhance fat oxidation and/or improve variables associated with cardiometabolic health and body composition more so than dGTE or placebo supplementation in healthy, but overweight individuals?

This study will involve participants attending sessions at Compass House, ARU, undertaking the following:

  • Baseline trial: all participants will attend a subject briefing, provide written, informed consent prior to participation. Following this, all participants will undertake a baseline test for maximal fat oxidation rates (FATmax) and oxygen uptake using a standardised incremental cycling exercise protocol and expired air analysis
  • Intervention period: participants will be randomly assigned to either dGTE (400mg EGCG daily), dGTE with antioxidants (150mg quercetin, 150mg alpha-lipoic acid) or placebo for 8 weeks. During this period, participants will undertake regular aerobic exercise (3x/ week; 45mins; at ~ FATmax intensity)
  • Experimental evaluation of progress will be assessed at weeks 0,2,4, and 8. During laboratory visits, participants will be required to have a single venepuncture blood sample, assessment of blood pressure/ body composition (skinfold, bioelectrical impedance, waist circumference), assessment of FATmax, and assessment of fat oxidation during steady state exercise at FATmax.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants randomly assigned to either placebo, green tea extract (GTE) or GTE with antioxidants in a parallel, double blind manner
Masking: Double (Participant, Investigator)
Masking Description: Nutritional supplements will be provided in a randomised, double-blinded manner. Both the participants and research testers will be masked from knowing the specifics of the supplement intervention.
Primary Purpose: Basic Science
Official Title: The Effect of Green Tea Supplementation Strategies on Fat Oxidation and Body Composition in Overweight Individuals
Actual Study Start Date : December 1, 2018
Actual Primary Completion Date : December 1, 2019
Actual Study Completion Date : March 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antioxidants

Arm Intervention/treatment
Placebo Comparator: Placebo group
Placebo - capsulated, colour matched potato starch (~450mg per capsule) - provided by Biocare Ltd., UK using standard 00 vegetable capsules (hydroxypropyl methylcellulose). Dosage: 2 divided doses (1 capsule mid morning, 1 capsule mid afternoon) - daily for 8 weeks.
Dietary Supplement: Placebo control
8 week supplementation period, with participants consuming 2 capsules per day containing potato starch
Other Name: Placebo

Experimental: Green tea 1
Capsulated decaffeinated green tea extract (dGTE) (standardised to 70% EGCG concentration, 571mg total per day, containing 400mg EGCG - provided by Biocare Ltd., UK using standard 00 vegetable capsules (hydroxypropyl methylcellulose). Dosage: 2 divided doses (1 capsule mid morning, 1 capsule mid afternoon) - daily for 8 weeks.
Dietary Supplement: GTE 1
8 week supplementation period, with participants consuming 2 capsules per day containing green tea extract (571mg/d)
Other Name: Decaffeinated green tea extract

Experimental: Green tea 2
Capsulated decaffeinated green tea extract (dGTE) (standardised to 70% EGCG concentration, 571mg total per day, containing 400mg EGCG + 150mg quercitin and 150mg alpha lipoic acid - provided by Biocare Ltd., UK using standard 00 vegetable capsules (hydroxypropyl methylcellulose). Dosage: 2 divided doses (1 capsule mid morning, 1 capsule mid afternoon) - daily for 8 weeks.
Dietary Supplement: GTE 2
8 week supplementation period, with participants consuming 2 capsules per day containing green tea extract with additional antioxidants (150mg of quercitin and 150mg of alpha lipoic acid)
Other Name: Decaffeinated green tea extract and antioxidants




Primary Outcome Measures :
  1. Fat oxidation (max) [ Time Frame: Change from Baseline maximal fat oxidation at 1 month ]
    Assessment of maximal fat oxidation rate (via expired air) during incremental exercise

  2. Fat oxidation (max) [ Time Frame: Change from Baseline maximal fat oxidation at 2 months ]
    Assessment of maximal fat oxidation rate (via expired air) during incremental exercise

  3. Fat oxidation (min) [ Time Frame: Change from Baseline minimum fat oxidation at 1 month ]
    Assessment of exercise intensity at which point fat oxidation is negligable

  4. Fat oxidation (min) [ Time Frame: Change from Baseline minimum fat oxidation at 2 months ]
    Assessment of exercise intensity at which point fat oxidation is negligable


Secondary Outcome Measures :
  1. Height [ Time Frame: Change from baseline height at 1 month ]
    Assessment of height (in metres)

  2. Height [ Time Frame: Change from baseline height at 2 months ]
    Assessment of height (in metres)

  3. Weight [ Time Frame: Change from baseline weight at 1 month ]
    Assessment of weight (in kilograms)

  4. Weight [ Time Frame: Change from baseline weight at 2 months ]
    Assessment of weight (in kilograms)

  5. Bodyfat percentage [ Time Frame: Change from baseline bodyfat percentage at 1 month ]
    Assessment of bodyfat (%)

  6. Bodyfat percentage [ Time Frame: Change from baseline bodyfat percentage at 2 months ]
    Assessment of bodyfat (%)

  7. Waist to hip ratio [ Time Frame: Change from baseline waist to hip ratio at 1 month ]
    Assessment of waist to hip ratio (cm)

  8. Waist to hip ratio [ Time Frame: Change from baseline waist to hip ratio at 2 months ]
    Assessment of waist to hip ratio (cm)

  9. Body mass index [ Time Frame: Change from baseline BMI at 1 month ]
    Assessment of body mass index or BMI (measured in kilograms per metre squared)

  10. Body mass index [ Time Frame: Change from baseline BMI at 2 months ]
    Assessment of body mass index or BMI (measured in kilograms per metre squared)

  11. Central abdomen depth [ Time Frame: Change from baseline central abdominal depth at 1 month ]
    Assessment of central abdomen depth (in cm)

  12. Central abdomen depth [ Time Frame: Change from baseline central abdominal depth at 2 months ]
    Assessment of central abdomen depth (in cm)

  13. Blood cholesterol [ Time Frame: Change from Baseline at 1 month ]
    Assessment of total cholesterol, triglycerides, HDL-c and LDL-c (all in mmol/L)

  14. Blood cholesterol [ Time Frame: Change from Baseline at 2 months ]
    Assessment of total cholesterol, triglycerides, HDL-c and LDL-c (all in mmol/L)

  15. Blood glucose [ Time Frame: Change from Baseline blood glucose at 1 month ]
    Assessment of blood glucose (in mmol/L)

  16. Blood glucose [ Time Frame: Change from Baseline blood glucose at 2 months ]
    Assessment of blood glucose (in mmol/L)

  17. Blood insulin [ Time Frame: Change from Baseline blood insulin at 1 month ]
    Assessment of blood glucose (in pmol/L)

  18. Blood insulin [ Time Frame: Change from Baseline blood insulin at 2 months ]
    Assessment of blood glucose (in pmol/L)

  19. Blood leptin [ Time Frame: Change from Baseline blood leptin at 1 month ]
    Assessment of blood leptin (in ng/ml)

  20. Blood leptin [ Time Frame: Change from Baseline blood leptin at 2 months ]
    Assessment of blood leptin (in ng/ml)

  21. Blood adiponectin [ Time Frame: Change from Baseline blood adiponectin at 1 month ]
    Assessment of blood adiponectin (in ug/ml)

  22. Blood adiponectin [ Time Frame: Change from Baseline blood adiponectin at 2 months ]
    Assessment of blood adiponectin (in ug/ml)

  23. Blood fatty acids and glycerol [ Time Frame: Change from Baseline at 1 month ]
    Assessment of blood free fatty acids and glycerol (both in umol/L)

  24. Blood fatty acids and glycerol [ Time Frame: Change from Baseline at 2 months ]
    Assessment of blood free fatty acids and glycerol (both in umol/L)

  25. Blood liver enzymes [ Time Frame: Change from baseline at 1 month ]
    Assessment of blood liver enzymes including alanine aminotransferase(ALT), aspartate aminotransferase (AST) and alkaline phosphatase (ALP) (all measured in U/L)

  26. Blood liver enzymes [ Time Frame: Change from baseline at 2 months ]
    Assessment of blood liver enzymes including alanine aminotransferase(ALT), aspartate aminotransferase (AST) and alkaline phosphatase (ALP) (all measured in U/L)

  27. Blood bilirubin [ Time Frame: Change from baseline bilirubin at 1 month ]
    Assessment of blood concentration of bilirubin (in umol/L)

  28. Blood bilirubin [ Time Frame: Change from baseline bilirubin at 2 months ]
    Assessment of blood concentration of bilirubin (in umol/L)

  29. Respiratory measures (oxygen, carbon dioxide) during steady state exercise [ Time Frame: Change from baseline at 1 month ]
    Assessment of expired oxygen and carbon dioxide (in litres per minute)

  30. Respiratory measures (oxygen, carbon dioxide) during steady state exercise [ Time Frame: Change from baseline at 2 months ]
    Assessment of mean expired oxygen and carbon dioxide (in litres per minute)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Men and women, UK based, above 18 years of age
  2. Below 45 years of age (for men) and below 55 years of age (for women)
  3. Baseline maximal oxygen uptake >25ml/kg/min and <45ml/kg/min representative of normal (but not high) fitness levels; and a body mass index (BMI) >25kg/m2 and <33kg/m2
  4. All participants: No known history (including family history) of heart abnormalities, hypertension, coronary heart disease or diabetes (determined from pre-study health screen questionnaire)
  5. All participants: No known history of liver related disorders (e.g. hepatitis, Wilsons disease, cirrhosis).
  6. All participants: Not currently suffering from any musculo-skeletal injury, or any other reason that may prevent participation in cardiovascular exercise
  7. All participants: Have not suffered from recent viral infections ie: influenza (defined within the prior 2 months)
  8. All participants: Not suffering from any known blood related disorders, including blood coagulation abnormalities, or have any adverse reactions to blood taking
  9. All participants: Not taking any prescribed or over-the-counter medication which may influence exercise training (with the exception of inhalers for exercise induced asthma or contraceptive pill)
  10. All participants: Not consuming or prepared to refrain from consumption, any commercial supplementation which conflicts with the study parameters ie: creatine, other green tea or weight loss products.

Exclusion Criteria:

  1. Anyone below the age of 18 years, or above 45 years (for men) and 55 years (for women) - based on exercise testing guidelines by the American College of Sports Medicine (ACSM).
  2. Those who do not meet the criteria for baseline maximal oxygen uptake or BMI assessment
  3. All participants: anyone with a known history (including family history) of heart abnormalities, hypertension, coronary heart disease or diabetes (determined from pre-study health screen questionnaire)
  4. All participants: anyone with a known previous history of liver related disorders.
  5. All participants: Anyone suffering from a current musculo-skeletal injury, or any other reason that may prevent participation in cardiovascular exercise
  6. All participants: those suffering from recent viral infections ie: influenza (defined within the prior 2 months)
  7. All participants: Those with known blood related disorders, including blood coagulation abnormalities, or have any adverse reactions to blood taking. This includes any participant who has or potentially has an infectious disease, inc. HIV, and all types of hepatitis.
  8. All participants: Anyone taking any prescribed or over-the-counter medication which may influence exercise training (with the exception of inhalers for exercise induced asthma or contraceptive pill)
  9. All participants: Anyone consuming or not prepared to refrain from consumption, any commercial supplementation which conflicts with the study parameters ie: creatine, other green tea or weight loss products.
  10. FEMALE ONLY: Any participant who is, suspects they may be or becomes pregnant during the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04628624


Locations
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United Kingdom
Anglia Ruskin University
Cambridge, United Kingdom, CB1 1PT
Sponsors and Collaborators
Anglia Ruskin University
Investigators
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Principal Investigator: Justin Roberts, PhD Anglia Ruskin University
Publications:

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Responsible Party: Justin Roberts, Associate Professor, Anglia Ruskin University
ClinicalTrials.gov Identifier: NCT04628624    
Other Study ID Numbers: FST/FREP/17/703
First Posted: November 13, 2020    Key Record Dates
Last Update Posted: November 13, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Justin Roberts, Anglia Ruskin University:
Green Tea
Exercise Metabolism
Additional relevant MeSH terms:
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Overweight
Overnutrition
Nutrition Disorders
Body Weight
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs