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

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Effect of Green Tea Supplementation Strategies on Fat Oxidation and Body Composition in Overweight Individuals

Conditions
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Overweight and Obesity, Fat Burn

Intervention / Treatment
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* Dietary Supplement: Placebo control
* Dietary Supplement: GTE 1
* Dietary Supplement: GTE 2


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants randomly assigned to either placebo, green tea extract (GTE) or GTE with antioxidants in a parallel, double blind manner
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo group<br>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<br>* 8 week supplementation period, with participants consuming 2 capsules per day containing potato starch<br>* Other names: Placebo;|
| Experimental: Green tea 1<br>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<br>* 8 week supplementation period, with participants consuming 2 capsules per day containing green tea extract (571mg/d)<br>* Other names: Decaffeinated green tea extract;|
| Experimental: Green tea 2<br>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<br>* 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)<br>* Other names: Decaffeinated green tea extract and antioxidants;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fat oxidation (max) | Assessment of maximal fat oxidation rate (via expired air) during incremental exercise | Change from Baseline maximal fat oxidation at 1 month | 
| Fat oxidation (max) | Assessment of maximal fat oxidation rate (via expired air) during incremental exercise | Change from Baseline maximal fat oxidation at 2 months | 
| Fat oxidation (min) | Assessment of exercise intensity at which point fat oxidation is negligable | Change from Baseline minimum fat oxidation at 1 month | 
| Fat oxidation (min) | Assessment of exercise intensity at which point fat oxidation is negligable | Change from Baseline minimum fat oxidation at 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Height | Assessment of height (in metres) | Change from baseline height at 1 month | 
| Height | Assessment of height (in metres) | Change from baseline height at 2 months | 
| Weight | Assessment of weight (in kilograms) | Change from baseline weight at 1 month | 
| Weight | Assessment of weight (in kilograms) | Change from baseline weight at 2 months | 
| Bodyfat percentage | Assessment of bodyfat (%) | Change from baseline bodyfat percentage at 1 month | 
| Bodyfat percentage | Assessment of bodyfat (%) | Change from baseline bodyfat percentage at 2 months | 
| Waist to hip ratio | Assessment of waist to hip ratio (cm) | Change from baseline waist to hip ratio at 1 month | 
| Waist to hip ratio | Assessment of waist to hip ratio (cm) | Change from baseline waist to hip ratio at 2 months | 
| Body mass index | Assessment of body mass index or BMI (measured in kilograms per metre squared) | Change from baseline BMI at 1 month | 
| Body mass index | Assessment of body mass index or BMI (measured in kilograms per metre squared) | Change from baseline BMI at 2 months | 
| Central abdomen depth | Assessment of central abdomen depth (in cm) | Change from baseline central abdominal depth at 1 month | 
| Central abdomen depth | Assessment of central abdomen depth (in cm) | Change from baseline central abdominal depth at 2 months | 
| Blood cholesterol | Assessment of total cholesterol, triglycerides, HDL-c and LDL-c (all in mmol/L) | Change from Baseline at 1 month | 
| Blood cholesterol | Assessment of total cholesterol, triglycerides, HDL-c and LDL-c (all in mmol/L) | Change from Baseline at 2 months | 
| Blood glucose | Assessment of blood glucose (in mmol/L) | Change from Baseline blood glucose at 1 month | 
| Blood glucose | Assessment of blood glucose (in mmol/L) | Change from Baseline blood glucose at 2 months | 
| Blood insulin | Assessment of blood glucose (in pmol/L) | Change from Baseline blood insulin at 1 month | 
| Blood insulin | Assessment of blood glucose (in pmol/L) | Change from Baseline blood insulin at 2 months | 
| Blood leptin | Assessment of blood leptin (in ng/ml) | Change from Baseline blood leptin at 1 month | 
| Blood leptin | Assessment of blood leptin (in ng/ml) | Change from Baseline blood leptin at 2 months | 
| Blood adiponectin | Assessment of blood adiponectin (in ug/ml) | Change from Baseline blood adiponectin at 1 month | 
| Blood adiponectin | Assessment of blood adiponectin (in ug/ml) | Change from Baseline blood adiponectin at 2 months | 
| Blood fatty acids and glycerol | Assessment of blood free fatty acids and glycerol (both in umol/L) | Change from Baseline at 1 month | 
| Blood fatty acids and glycerol | Assessment of blood free fatty acids and glycerol (both in umol/L) | Change from Baseline at 2 months | 
| Blood liver enzymes | Assessment of blood liver enzymes including alanine aminotransferase(ALT), aspartate aminotransferase (AST) and alkaline phosphatase (ALP) (all measured in U/L) | Change from baseline at 1 month | 
| Blood liver enzymes | Assessment of blood liver enzymes including alanine aminotransferase(ALT), aspartate aminotransferase (AST) and alkaline phosphatase (ALP) (all measured in U/L) | Change from baseline at 2 months | 
| Blood bilirubin | Assessment of blood concentration of bilirubin (in umol/L) | Change from baseline bilirubin at 1 month | 
| Blood bilirubin | Assessment of blood concentration of bilirubin (in umol/L) | Change from baseline bilirubin at 2 months | 
| Respiratory measures (oxygen, carbon dioxide) during steady state exercise | Assessment of expired oxygen and carbon dioxide (in litres per minute) | Change from baseline at 1 month | 
| Respiratory measures (oxygen, carbon dioxide) during steady state exercise | Assessment of mean expired oxygen and carbon dioxide (in litres per minute) | Change from baseline at 2 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Green Tea, Exercise Metabolism