NCT03199430

Brief Summary

The aim of this study was to explore the impact of acute ingestion of the polyphenol epigallocatechin galate (EGCG) on catecholamine, catecholamine metabolite, systemic metabolic and cardio-vascular variables across a range of exercise intensities during graded cycle exercise in man.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Sep 2015

Shorter than P25 for phase_4

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

August 3, 2016

Completed
11 months until next milestone

First Posted

Study publicly available on registry

June 27, 2017

Completed
Last Updated

June 27, 2017

Status Verified

June 1, 2017

Enrollment Period

4 months

First QC Date

August 3, 2016

Last Update Submit

June 22, 2017

Conditions

EGCG Influence on Catecholamine Metabolism

Keywords

catecholaminesExerciselipid metabolism

Outcome Measures

Primary Outcomes (3)

  • change in Adrenaline & Noradrenaline concentrations (nmol.l-1)

    Changes in Adrenaline \& Noradrenaline concentrations (nmol.l-1) from rest to exhaustion under EGCG and placebo conditions.

    Relativised to each metabolic domain; rest, 2 hours post ingestion, highest lipid oxidation rate during exercise, lactate threshold and VO2peak (participant dependant)

  • Changes in Metanephrine and Normetanephrine (pmol.l-1)

    Changes in Metanephrine \& Normetanephrine concentrations (pmol.l-1) from rest to exhaustion under EGCG and placebo conditions.

    Relativised to each metabolic domain; rest, 2 hours post ingestion, highest lipid oxidation rate during exercise, lactate threshold and VO2peak (participant dependant)

  • Changes in lipid and carbohydrate oxidation (g.min-1)

    Changes in lipid and carbohydrate oxidation (g.min-1) from rest to exhaustion under EGCG and placebo conditions.

    Over a period of approximately 2 and a half hours with the data collected relativised to each metabolic domain; rest, highest lipid oxidation rate during exercise, lactate threshold and VO2peak (participant dependant)

Secondary Outcomes (4)

  • Changes in blood glucose concentrations (mmol.l-1)

    Relativised to each metabolic domain; rest, two hours post ingestion, highest lipid oxidation rate during exercise, lactate threshold and VO2peak (participant dependant)

  • Changes in exercise performance (S) under EGCG and placebo conditions.

    over a period of approximately 30 minutes from rest to volitional exhaustion.

  • Changes in blood lactate concentrations (mmol.l-1)

    Relativised to each metabolic domain; rest, two hours post ingestion, highest lipid oxidation rate during exercise, lactate threshold and VO2peak (participant dependant)

  • Changes in exercise performance (W) under EGCG and placebo conditions.

    over a period of approximately 30 minutes from rest to volitional exhaustion.

Study Arms (2)

Placebo

PLACEBO COMPARATOR

1450mg Corn flour

Dietary Supplement: Placebo

Epigallocatechin gallate

ACTIVE COMPARATOR

1450mg Epigallocatechin gallate

Dietary Supplement: Epigallocatechin gallate

Interventions

Epigallocatechin gallateDIETARY_SUPPLEMENT
Epigallocatechin gallate
PlaceboDIETARY_SUPPLEMENT

1450mg Corn Flour

Placebo

Eligibility Criteria

Age18 Years - 35 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age 18-35 years old. Caffeine intake ≤400 mg.d-1 (thus less than four cups of tea/ coffee or caffeinated soda beverages).
  • Habitual participation in exercise three to five times per week for 30-90 minutes per formal exercise session.

You may not qualify if:

  • Female Any injury, assessed via health screening questionnaire prior to the start of the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Newell J, Higgins D, Madden N, Cruickshank J, Einbeck J, McMillan K, McDonald R. Software for calculating blood lactate endurance markers. J Sports Sci. 2007 Oct;25(12):1403-9. doi: 10.1080/02640410601128922.

    PMID: 17786693BACKGROUND

  • Frayn KN. Calculation of substrate oxidation rates in vivo from gaseous exchange. J Appl Physiol Respir Environ Exerc Physiol. 1983 Aug;55(2):628-34. doi: 10.1152/jappl.1983.55.2.628.

    PMID: 6618956BACKGROUND

  • Jeukendrup AE, Wallis GA. Measurement of substrate oxidation during exercise by means of gas exchange measurements. Int J Sports Med. 2005 Feb;26 Suppl 1:S28-37. doi: 10.1055/s-2004-830512.

    PMID: 15702454BACKGROUND

MeSH Terms

Conditions

Motor Activity

Interventions

epigallocatechin gallate

Condition Hierarchy (Ancestors)

Behavior

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Postgraduate Student

Study Record Dates

First Submitted

August 3, 2016

First Posted

June 27, 2017

Study Start

September 1, 2015

Primary Completion

January 1, 2016

Study Completion

February 1, 2016

Last Updated

June 27, 2017

Record last verified: 2017-06