- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03404947
Substrate Metabolism During Exercise Following Ingestion of Ethanol
Substrate Metabolism During 2 Hours of Moderate Intensity Exercise Following Ingestion of Ethanol in Man
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Somerset
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Bath, Somerset, United Kingdom, BA2 7AY
- University of Bath
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
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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.
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No Intervention: No Ethanol
Participants will ingest a volume matched beverage of water only.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in muscle glycogen content
Time Frame: Change in muscle glycogen content over 2 hours of moderate intensity cycling exercise
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Muscle biopsy and subsequent biochemical analysis
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Change in muscle glycogen content over 2 hours of moderate intensity cycling exercise
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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.
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Venous blood samples will be taken and biochemically analysed for blood glucose concentration.
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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.
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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.
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Venous blood samples will be taken and biochemically analysed for NEFA concentration.
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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.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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Venous blood samples will be taken and biochemically analysed for blood ethanol concentration.
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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.
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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.
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Venous blood samples will be taken and biochemically analysed for blood lactate concentration.
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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.
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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
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Carbohydrate oxidation will be determined through indirect calorimetry via the douglas bag technique.
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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
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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
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Fat oxidation will be determined through indirect calorimetry via the douglas bag technique.
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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
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: James Betts, PhD, University of Bath
- Principal Investigator: Harry Smith, University of Bath
Publications and helpful links
General 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ETOH-hs565
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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