NCT03404947

Brief Summary

This study will investigate how ethanol (pure alcohol) influences carbohydrate and fat metabolism during prolonged, moderate intensity exercise. Participants will perform two bouts of cycling exercise with or without prior ingestion of ethanol, in a randomised order, separated by one week.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

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

November 13, 2017

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

December 5, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 19, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 29, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 29, 2018

Completed
Last Updated

March 6, 2019

Status Verified

March 1, 2019

Enrollment Period

8 months

First QC Date

December 5, 2017

Last Update Submit

March 5, 2019

Conditions

Keywords

ExerciseMetabolismNutrition

Outcome Measures

Primary Outcomes (3)

  • Change in muscle glycogen content

    Muscle biopsy and subsequent biochemical analysis

    Change in muscle glycogen content over 2 hours of moderate intensity cycling exercise

  • Blood glucose concentration

    Venous blood samples will be taken and biochemically analysed for blood glucose concentration.

    Blood samples will be taken every 15 minutes during rest and the first hour of exercise, they will be taken every 30 minutes in the second hour of exercise.

  • Blood non-esterified fatty acid (NEFA) concentration

    Venous blood samples will be taken and biochemically analysed for NEFA concentration.

    Blood samples will be taken every 15 minutes during rest and the first hour of exercise, they will be taken every 30 minutes in the second hour of exercise.

Secondary Outcomes (4)

  • Blood ethanol concentration

    Blood samples will be taken every 15 minutes during rest and the first hour of exercise, they will be taken every 30 minutes in the second hour of exercise.

  • Blood lactate concentration

    Blood samples will be taken every 15 minutes during rest and the first hour of exercise, they will be taken every 30 minutes in the second hour of exercise.

  • Carbohydrate Oxidation

    Expired breath samples will be collected at baseline before beverage consumption and again after 1 hours rest. Samples will collected every 15 minutes during the first hour of exercise and every 30 minutes during the second hour

  • Fat Oxidation

    Expired breath samples will be collected at baseline before beverage consumption and again after 1 hours rest. Samples will collected every 15 minutes during the first hour of exercise and every 30 minutes during the second hour

Study Arms (2)

Ethanol

EXPERIMENTAL

Participants will ingest ethanol (in the form of 40% ethanol) at an ingestion rate of 0.1 grams/kg lean body mass/hour in a solution with water.

Dietary Supplement: Ethanol

No Ethanol

NO INTERVENTION

Participants will ingest a volume matched beverage of water only.

Interventions

EthanolDIETARY_SUPPLEMENT

For one exercise session, participants will be asked to ingest a quantity of ethanol (in the form of vodka) sufficient to maximally stimulate liver alcohol metabolism.

Ethanol

Eligibility Criteria

Age18 Years - 30 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Habitual alcohol consumer (average 1-14 units per week)
  • BMI 18.5 - 29.9 kg/m2
  • Be able to attend the laboratory and willing to participate in necessary protocols
  • Be willing to undertake the durations of the exercise protocol (2 hours) \]
  • Have the capacity and willingness to provide informed consent (oral and written)

You may not qualify if:

  • Non-or excessive alcohol drinkers (0 or \>14 units per week)
  • History of substance abuse
  • Habitual/previously habitual smokers
  • BMI \>30.0 kg/m2
  • Experience contraindications to the administration of the proposed anaesthetic (Lidocaine Hydrochloride)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Bath

Bath, Somerset, BA2 7AY, United Kingdom

Location

Related Publications (3)

  • Jorfeldt L, Juhlin-Dannfelt A. The influence of ethanol on human splanchnic and skeletal muscle metabolism during exercise. Scand J Clin Lab Invest. 1977 Nov;37(7):609-18. doi: 10.3109/00365517709100653. No abstract available.

    PMID: 594641BACKGROUND
  • Juhlin-Dannfelt A, Ahlborg G, Hagenfeldt L, Jorfeldt L, Felig P. Influence of ethanol on splanchnic and skeletal muscle substrate turnover during prolonged exercise in man. Am J Physiol. 1977 Sep;233(3):E195-202. doi: 10.1152/ajpendo.1977.233.3.E195. No abstract available.

    PMID: 910908BACKGROUND
  • Juhlin-Dannfelt A, Jorfeldt L, Hagenfeldt L, Hulten B. Influence of ethanol on non-esterified fatty acid and carbohydrate metabolism during exercise in man. Clin Sci Mol Med. 1977 Sep;53(3):205-14. doi: 10.1042/cs0530205. No abstract available.

    PMID: 913043BACKGROUND

MeSH Terms

Conditions

Motor Activity

Interventions

Ethanol

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

AlcoholsOrganic Chemicals

Study Officials

  • Harry Smith

    University of Bath

    PRINCIPAL INVESTIGATOR
  • James Betts, PhD

    University of Bath

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 5, 2017

First Posted

January 19, 2018

Study Start

November 13, 2017

Primary Completion

June 29, 2018

Study Completion

June 29, 2018

Last Updated

March 6, 2019

Record last verified: 2019-03

Locations