ClinicalTrials.gg
CompletedNCT03404947Updated Mar 6, 2019

Substrate Metabolism During Exercise Following Ingestion of Ethanol

An interventional study of Ethanol in Exercise Metabolism Following Ethanol Ingestion, sponsored by University of Bath. Completed at 1 site in United Kingdom. Open to male participants aged 18 Years to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-03-06.

Sponsored by University of Bath · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
8
Allocation
Randomized
Ages
18 Years to 30 Years
Sex
Male
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 18 studies in Motor Activity by University of Bath — 3 open to participants now, 4 under way, none of them phase 3. Motor Activity · University of Bath.

Enrollment
14th of 15
8 · median 30
Started
2017
with 1 other
No phase
15 of 18
2 open now
Registered
6th of 18
by date

Among the 18 studies in Motor Activity by University of Bath, this one is the 14th largest by enrollment of the 15 interventional ones that give a count, is one of 2 that started in 2017, is one of 15 with no phase, and was the 6th registered.

Motor Activity

9,798 studies on the registry are indexed under Motor Activity; 1,910 are open to participants now.

Browse Motor Activity studies →

Open to participants now

3 of the 18 studies in Motor Activity by University of Bath are open now, in 1 country. Recruiting first, the newest first:

By country, each count listing its studies:

All 3 open studies →

Where they have run

Who these studies take

Of the 1,201 Motor Activity studies recruiting now, 517 (43%) set no upper age limit and 535 (45%) stop at 75 or younger; 180 take children under 18; 420 take healthy volunteers.

This study: 18 Years to 30 Years · male · healthy volunteers too.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 18 studies in Motor Activity by University of Bath, or all of them as a file.
02

Study 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.

Read the detailed description

Very little research has investigated the influence of ethanol on metabolism during prolonged exercise. Evidence suggests that delivery of fat to the working muscles during exercise may be limited with ethanol and therefore this may shift the relative proportions of energy derived from muscle stores of carbohydrate as a result (Jorfeldt \& Juhlin-Dannfelt, 1976).

The current study aims to investigate how a small-moderate dose of ethanol influences where energy is derived from during a prolonged bout of moderate intensity cycling exercise.

Participants will visit the lab on three occasions, once for preliminary measurements of fitness and body composition, and twice for the experimental bouts of exercise. Body composition will be assessed using a dual-energy x-ray absorptiometry (DEXA) scan, which will measure lean mass, fat mass, and bone mineral density. Participants will then perform an incremental maximal oxygen uptake test to determine intensity for the experimental bouts of exercise.

The two experimental bouts of exercise include cycling on an exercise bike for 2 hours at 55% of their maximal oxygen uptake (i.e. fitness) following 1 hours rest. This will be performed under two conditions: with and without ethanol ingestion. Pre and post exercise muscle biopsies will be collected to assess muscle metabolism, with regular blood samples and expired breath samples being collected to further investigate fuel delivery and use by the working tissues. The experimental bouts of exercise will be performed 1 week apart in a randomised order.

03

Conditions studied

  • Exercise Metabolism Following Ethanol Ingestion

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Keywords

  • Exercise
  • Metabolism
  • Nutrition
04

Who can participate

Ages eligible
18 Years to 30 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Habitual alcohol consumer (average 1-14 units per week)
  • 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 (oral and written)

Exclusion criteria

Exclusion Criteria:

  • Non-or excessive alcohol drinkers (0 or >14 units per week)
  • History of substance abuse
  • Habitual/previously habitual smokers
  • >30.0 kg/m2
  • Experience to the administration of the proposed anaesthetic (Lidocaine Hydrochloride)
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
8 participants (actual)

Study arms

  • Experimental
    Ethanol

    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 intervention
    No Ethanol

    Participants will ingest a volume matched beverage of water only.

Interventions

  • Dietary supplementEthanol

    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.

06

What researchers measure

Primary outcomes

  1. Change in muscle glycogen content

    Muscle biopsy and subsequent biochemical analysis

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

  2. Blood glucose concentration

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

    Time frame: 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.

  3. Blood non-esterified fatty acid (NEFA) concentration

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

    Time frame: 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

  1. Blood ethanol concentration

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

    Time frame: 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.

  2. Blood lactate concentration

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

    Time frame: 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.

  3. Carbohydrate Oxidation

    Carbohydrate oxidation will be determined through indirect calorimetry via the douglas bag technique.

    Time frame: 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

  4. Fat Oxidation

    Fat oxidation will be determined through indirect calorimetry via the douglas bag technique.

    Time frame: 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

07

Study locations

1 site
  • University of Bath
    Bath, Somerset BA2 7AY, United Kingdom
08

References and documents

Publications

  • 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. PubMed 594641 ↗
  • 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. PubMed 910908 ↗
  • 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. PubMed 913043 ↗

Individual participant data

Plan to share: Undecided

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Nov 2017 to primary completion in Jun 2018, 7 months.

Of 5,147 non-industry interventional studies with no phase under Motor Activity, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 36. This study's 7 months is below that.

Counting every sponsor, half of 5,207 studies reached it within 17 months; a quarter within 7 and three quarters within 36.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 5, 2017
First posted
Jan 19, 2018
StartActual
Nov 13, 2017
Primary completionActual
Jun 29, 2018
CompletionActual
Jun 29, 2018
Last update
Mar 6, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 6, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03404947
Lead sponsor
University of Bath
Responsible party
James Betts (Principal Investigator, University of Bath) — Principal investigator
First posted
Jan 19, 2018
Start date
Nov 13, 2017
Primary completion
Jun 29, 2018
Completion
Jun 29, 2018
Last update
Mar 6, 2019

Study contacts

Harry Smith
principal investigator · University of Bath
James Betts, PhD
principal investigator · University of Bath

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Ethanol

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