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

Primary Purpose

Overweight and Obesity, Fat Burn

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Placebo control
GTE 1
GTE 2
Sponsored by
Anglia Ruskin University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Overweight and Obesity focused on measuring Green Tea, Exercise Metabolism

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Anglia Ruskin University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

Placebo group

Green tea 1

Green tea 2

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Fat oxidation (max)
Assessment of maximal fat oxidation rate (via expired air) during incremental exercise
Fat oxidation (max)
Assessment of maximal fat oxidation rate (via expired air) during incremental exercise
Fat oxidation (min)
Assessment of exercise intensity at which point fat oxidation is negligable
Fat oxidation (min)
Assessment of exercise intensity at which point fat oxidation is negligable

Secondary Outcome Measures

Height
Assessment of height (in metres)
Height
Assessment of height (in metres)
Weight
Assessment of weight (in kilograms)
Weight
Assessment of weight (in kilograms)
Bodyfat percentage
Assessment of bodyfat (%)
Bodyfat percentage
Assessment of bodyfat (%)
Waist to hip ratio
Assessment of waist to hip ratio (cm)
Waist to hip ratio
Assessment of waist to hip ratio (cm)
Body mass index
Assessment of body mass index or BMI (measured in kilograms per metre squared)
Body mass index
Assessment of body mass index or BMI (measured in kilograms per metre squared)
Central abdomen depth
Assessment of central abdomen depth (in cm)
Central abdomen depth
Assessment of central abdomen depth (in cm)
Blood cholesterol
Assessment of total cholesterol, triglycerides, HDL-c and LDL-c (all in mmol/L)
Blood cholesterol
Assessment of total cholesterol, triglycerides, HDL-c and LDL-c (all in mmol/L)
Blood glucose
Assessment of blood glucose (in mmol/L)
Blood glucose
Assessment of blood glucose (in mmol/L)
Blood insulin
Assessment of blood glucose (in pmol/L)
Blood insulin
Assessment of blood glucose (in pmol/L)
Blood leptin
Assessment of blood leptin (in ng/ml)
Blood leptin
Assessment of blood leptin (in ng/ml)
Blood adiponectin
Assessment of blood adiponectin (in ug/ml)
Blood adiponectin
Assessment of blood adiponectin (in ug/ml)
Blood fatty acids and glycerol
Assessment of blood free fatty acids and glycerol (both in umol/L)
Blood fatty acids and glycerol
Assessment of blood free fatty acids and glycerol (both in umol/L)
Blood liver enzymes
Assessment of blood liver enzymes including alanine aminotransferase(ALT), aspartate aminotransferase (AST) and alkaline phosphatase (ALP) (all measured in U/L)
Blood liver enzymes
Assessment of blood liver enzymes including alanine aminotransferase(ALT), aspartate aminotransferase (AST) and alkaline phosphatase (ALP) (all measured in U/L)
Blood bilirubin
Assessment of blood concentration of bilirubin (in umol/L)
Blood bilirubin
Assessment of blood concentration of bilirubin (in umol/L)
Respiratory measures (oxygen, carbon dioxide) during steady state exercise
Assessment of expired oxygen and carbon dioxide (in litres per minute)
Respiratory measures (oxygen, carbon dioxide) during steady state exercise
Assessment of mean expired oxygen and carbon dioxide (in litres per minute)

Full Information

First Posted
November 5, 2020
Last Updated
November 9, 2020
Sponsor
Anglia Ruskin University
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1. Study Identification

Unique Protocol Identification Number
NCT04628624
Brief Title
Green Tea Supplementation, Fat Oxidation and Body Composition in Overweight Individuals
Acronym
GreenTea
Official Title
The Effect of Green Tea Supplementation Strategies on Fat Oxidation and Body Composition in Overweight Individuals
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
December 1, 2018 (Actual)
Primary Completion Date
December 1, 2019 (Actual)
Study Completion Date
March 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Anglia Ruskin University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight and Obesity, Fat Burn
Keywords
Green Tea, Exercise Metabolism

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants randomly assigned to either placebo, green tea extract (GTE) or GTE with antioxidants in a parallel, double blind manner
Masking
ParticipantInvestigator
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.
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Green tea 1
Arm Type
Experimental
Arm Description
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.
Arm Title
Green tea 2
Arm Type
Experimental
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo control
Other Intervention Name(s)
Placebo
Intervention Description
8 week supplementation period, with participants consuming 2 capsules per day containing potato starch
Intervention Type
Dietary Supplement
Intervention Name(s)
GTE 1
Other Intervention Name(s)
Decaffeinated green tea extract
Intervention Description
8 week supplementation period, with participants consuming 2 capsules per day containing green tea extract (571mg/d)
Intervention Type
Dietary Supplement
Intervention Name(s)
GTE 2
Other Intervention Name(s)
Decaffeinated green tea extract and antioxidants
Intervention Description
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)
Primary Outcome Measure Information:
Title
Fat oxidation (max)
Description
Assessment of maximal fat oxidation rate (via expired air) during incremental exercise
Time Frame
Change from Baseline maximal fat oxidation at 1 month
Title
Fat oxidation (max)
Description
Assessment of maximal fat oxidation rate (via expired air) during incremental exercise
Time Frame
Change from Baseline maximal fat oxidation at 2 months
Title
Fat oxidation (min)
Description
Assessment of exercise intensity at which point fat oxidation is negligable
Time Frame
Change from Baseline minimum fat oxidation at 1 month
Title
Fat oxidation (min)
Description
Assessment of exercise intensity at which point fat oxidation is negligable
Time Frame
Change from Baseline minimum fat oxidation at 2 months
Secondary Outcome Measure Information:
Title
Height
Description
Assessment of height (in metres)
Time Frame
Change from baseline height at 1 month
Title
Height
Description
Assessment of height (in metres)
Time Frame
Change from baseline height at 2 months
Title
Weight
Description
Assessment of weight (in kilograms)
Time Frame
Change from baseline weight at 1 month
Title
Weight
Description
Assessment of weight (in kilograms)
Time Frame
Change from baseline weight at 2 months
Title
Bodyfat percentage
Description
Assessment of bodyfat (%)
Time Frame
Change from baseline bodyfat percentage at 1 month
Title
Bodyfat percentage
Description
Assessment of bodyfat (%)
Time Frame
Change from baseline bodyfat percentage at 2 months
Title
Waist to hip ratio
Description
Assessment of waist to hip ratio (cm)
Time Frame
Change from baseline waist to hip ratio at 1 month
Title
Waist to hip ratio
Description
Assessment of waist to hip ratio (cm)
Time Frame
Change from baseline waist to hip ratio at 2 months
Title
Body mass index
Description
Assessment of body mass index or BMI (measured in kilograms per metre squared)
Time Frame
Change from baseline BMI at 1 month
Title
Body mass index
Description
Assessment of body mass index or BMI (measured in kilograms per metre squared)
Time Frame
Change from baseline BMI at 2 months
Title
Central abdomen depth
Description
Assessment of central abdomen depth (in cm)
Time Frame
Change from baseline central abdominal depth at 1 month
Title
Central abdomen depth
Description
Assessment of central abdomen depth (in cm)
Time Frame
Change from baseline central abdominal depth at 2 months
Title
Blood cholesterol
Description
Assessment of total cholesterol, triglycerides, HDL-c and LDL-c (all in mmol/L)
Time Frame
Change from Baseline at 1 month
Title
Blood cholesterol
Description
Assessment of total cholesterol, triglycerides, HDL-c and LDL-c (all in mmol/L)
Time Frame
Change from Baseline at 2 months
Title
Blood glucose
Description
Assessment of blood glucose (in mmol/L)
Time Frame
Change from Baseline blood glucose at 1 month
Title
Blood glucose
Description
Assessment of blood glucose (in mmol/L)
Time Frame
Change from Baseline blood glucose at 2 months
Title
Blood insulin
Description
Assessment of blood glucose (in pmol/L)
Time Frame
Change from Baseline blood insulin at 1 month
Title
Blood insulin
Description
Assessment of blood glucose (in pmol/L)
Time Frame
Change from Baseline blood insulin at 2 months
Title
Blood leptin
Description
Assessment of blood leptin (in ng/ml)
Time Frame
Change from Baseline blood leptin at 1 month
Title
Blood leptin
Description
Assessment of blood leptin (in ng/ml)
Time Frame
Change from Baseline blood leptin at 2 months
Title
Blood adiponectin
Description
Assessment of blood adiponectin (in ug/ml)
Time Frame
Change from Baseline blood adiponectin at 1 month
Title
Blood adiponectin
Description
Assessment of blood adiponectin (in ug/ml)
Time Frame
Change from Baseline blood adiponectin at 2 months
Title
Blood fatty acids and glycerol
Description
Assessment of blood free fatty acids and glycerol (both in umol/L)
Time Frame
Change from Baseline at 1 month
Title
Blood fatty acids and glycerol
Description
Assessment of blood free fatty acids and glycerol (both in umol/L)
Time Frame
Change from Baseline at 2 months
Title
Blood liver enzymes
Description
Assessment of blood liver enzymes including alanine aminotransferase(ALT), aspartate aminotransferase (AST) and alkaline phosphatase (ALP) (all measured in U/L)
Time Frame
Change from baseline at 1 month
Title
Blood liver enzymes
Description
Assessment of blood liver enzymes including alanine aminotransferase(ALT), aspartate aminotransferase (AST) and alkaline phosphatase (ALP) (all measured in U/L)
Time Frame
Change from baseline at 2 months
Title
Blood bilirubin
Description
Assessment of blood concentration of bilirubin (in umol/L)
Time Frame
Change from baseline bilirubin at 1 month
Title
Blood bilirubin
Description
Assessment of blood concentration of bilirubin (in umol/L)
Time Frame
Change from baseline bilirubin at 2 months
Title
Respiratory measures (oxygen, carbon dioxide) during steady state exercise
Description
Assessment of expired oxygen and carbon dioxide (in litres per minute)
Time Frame
Change from baseline at 1 month
Title
Respiratory measures (oxygen, carbon dioxide) during steady state exercise
Description
Assessment of mean expired oxygen and carbon dioxide (in litres per minute)
Time Frame
Change from baseline at 2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Men and women, UK based, above 18 years of age Below 45 years of age (for men) and below 55 years of age (for women) 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 All participants: No known history (including family history) of heart abnormalities, hypertension, coronary heart disease or diabetes (determined from pre-study health screen questionnaire) All participants: No known history of liver related disorders (e.g. hepatitis, Wilsons disease, cirrhosis). All participants: Not currently suffering from any musculo-skeletal injury, or any other reason that may prevent participation in cardiovascular exercise All participants: Have not suffered from recent viral infections ie: influenza (defined within the prior 2 months) All participants: Not suffering from any known blood related disorders, including blood coagulation abnormalities, or have any adverse reactions to blood taking 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) 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: 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). Those who do not meet the criteria for baseline maximal oxygen uptake or BMI assessment 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) All participants: anyone with a known previous history of liver related disorders. All participants: Anyone suffering from a current musculo-skeletal injury, or any other reason that may prevent participation in cardiovascular exercise All participants: those suffering from recent viral infections ie: influenza (defined within the prior 2 months) 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. 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) 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. FEMALE ONLY: Any participant who is, suspects they may be or becomes pregnant during the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Justin Roberts, PhD
Organizational Affiliation
Anglia Ruskin University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Anglia Ruskin University
City
Cambridge
ZIP/Postal Code
CB1 1PT
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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25650043
Citation
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Results Reference
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19597519
Citation
Hursel R, Viechtbauer W, Westerterp-Plantenga MS. The effects of green tea on weight loss and weight maintenance: a meta-analysis. Int J Obes (Lond). 2009 Sep;33(9):956-61. doi: 10.1038/ijo.2009.135. Epub 2009 Jul 14.
Results Reference
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PubMed Identifier
20142827
Citation
Hursel R, Westerterp-Plantenga MS. Thermogenic ingredients and body weight regulation. Int J Obes (Lond). 2010 Apr;34(4):659-69. doi: 10.1038/ijo.2009.299. Epub 2010 Feb 9.
Results Reference
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Ichinose T, Nomura S, Someya Y, Akimoto S, Tachiyashiki K, Imaizumi K. Effect of endurance training supplemented with green tea extract on substrate metabolism during exercise in humans. Scand J Med Sci Sports. 2011 Aug;21(4):598-605. doi: 10.1111/j.1600-0838.2009.01077.x. Epub 2010 Mar 10.
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Green Tea Supplementation, Fat Oxidation and Body Composition in Overweight Individuals

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