Exercise Metabolism Following Ethanol IngestionNCT03404947
Substrate Metabolism During Exercise Following Ingestion of Ethanol
A study testing Ethanol in people with Exercise Metabolism Following Ethanol Ingestion, run by University of Bath at 1 site in United Kingdom.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Exercise Metabolism Following Ethanol Ingestion
- What is being tested?
- Ethanol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 13 Nov 2017to 29 Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Substrate Metabolism During 2 Hours of Moderate Intensity Exercise Following Ingestion of Ethanol in Man
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.
- Being tested
- Ethanol
- Keywords
- Exercise, Metabolism, Nutrition
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: Ethanol |
| No Ethanol | No intervention | Participants will ingest a volume matched beverage of water only. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in muscle glycogen content
Muscle biopsy and subsequent biochemical analysis
Measured: 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.
Measured: 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.
Measured: 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
Venous blood samples will be taken and biochemically analysed for blood ethanol concentration.
Measured: 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
Venous blood samples will be taken and biochemically analysed for blood lactate concentration.
Measured: 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
Carbohydrate oxidation will be determined through indirect calorimetry via the douglas bag technique.
Measured: 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
Fat oxidation will be determined through indirect calorimetry via the douglas bag technique.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2018
- Study start13 Nov 2017
- Primary completion29 Jun 2018
- Study completion29 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Exercise Metabolism Following Ethanol IngestionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bath
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, James Betts, University of Bath
- Investigators
- Harry Smith, Principal investigator, University of BathJames Betts, PhD, Principal investigator, University of Bath
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03404947
- Sponsor's protocol ID
- ETOH-hs565
- Status last verified
- Mar 2019
- First submitted
- 5 Dec 2017
- Last updated
- 6 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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 594641Juhlin-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 910908Juhlin-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
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Substrate Metabolism During 2 Hours of Moderate Intensity Exercise Following Ingestion of Ethanol in Man
- ClinicalTrials.gov ID
- NCT03404947
- Acronym / sponsor ID
- ETOH-hs565
- Keywords
- Exercise, Metabolism, Nutrition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University of BathUniversity, hospital or other
- Study start
- 13 Nov 2017 (actual)
- Primary completion
- 29 Jun 2018 (actual)
- Study completion
- 29 Jun 2018 (actual)
- First posted
- 19 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ethanol | Experimental | Dietary Supplement: EthanolParticipants 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. |
| No Ethanol | No intervention | –Participants will ingest a volume matched beverage of water only. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EthanolFor 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. | Dietary supplement | Ethanol |
Primary outcome
Change in muscle glycogen content
Time frame: Change in muscle glycogen content over 2 hours of moderate intensity cycling exercise
Muscle biopsy and subsequent biochemical analysis
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.
Venous blood samples will be taken and biochemically analysed for blood glucose concentration.
Blood non-esterified fatty acid (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.
Venous blood samples will be taken and biochemically analysed for NEFA concentration.
4 secondary outcomes
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.
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.
Carbohydrate Oxidation
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
Fat Oxidation
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2019.
- Background: PubMed 594641Jorfeldt 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.
- Background: PubMed 910908Juhlin-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.
- Background: PubMed 913043Juhlin-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.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Harry Smith principal investigator
University of Bath
James Betts, PhD principal investigator
University of Bath
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ethanol in people with Exercise Metabolism Following Ethanol Ingestion, run by University of Bath at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in muscle glycogen content (time frame: Change in muscle glycogen content over 2 hours of moderate intensity cycling exercise). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03404947, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2019.