Viewing Study NCT04628624



Ignite Creation Date: 2024-05-06 @ 3:25 PM
Last Modification Date: 2024-10-26 @ 1:49 PM
Study NCT ID: NCT04628624
Status: COMPLETED
Last Update Posted: 2020-11-13
First Post: 2020-11-05

Brief Title: Green Tea Supplementation Fat Oxidation and Body Composition in Overweight Individuals
Sponsor: Anglia Ruskin University
Organization: Anglia Ruskin University

Study Overview

Official Title: The Effect of Green Tea Supplementation Strategies on Fat Oxidation and Body Composition in Overweight Individuals
Status: COMPLETED
Status Verified Date: 2020-11
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: GreenTea
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-screeningfamiliarisation 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 mgd-1 EGCG for 6 days and 68 mgd-1 EGCG for 3 weeks did not alter metabolic or performance variables in healthy or endurance trained volunteers However the inclusion of 1005 mgd-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 andor 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 andor 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 024 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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None