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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status
completed
Actual enrollment (reported)
8 participants
Study completion date

February 2016

Actual (reported)
Listed locations
0 countries · 0 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

  1. Study Start

    September 2015

    Date type not reported

    This date has not been verified as actual or estimated.

  2. Primary Completion

    January 2016

    Actual (reported)

  3. Study Completion

    February 2016

    Actual (reported)

  4. First Submitted

    August 3, 2016

    Actual (reported)

  5. First Posted

    June 27, 2017

    Actual (reported)
Last Updated
June 27, 2017
Status Verified
June 2017
Last Update Submitted
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

Enrollment

8 participants — actual enrollment reported by the registry.

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 2015

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

January 2016

Actual (reported)

Study Completion

February 2016

Actual (reported)

Last Updated

June 27, 2017

Record last verified: 2017-06