Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
24 participants
INTERVENTIONAL
2021-11-10
2024-12-31
Brief Summary
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Despite the negative health consequences of chronic alcohol abuse, observational and cohort studies associate moderate alcohol consumption with a 20-30 % lower risk of cardiovascular diseases (CVD) and Type 2 Diabetes Mellitus (T2DM), compared to abstainers. Based on the J-shaped relationship between alcohol intake and the risk of cardiometabolic diseases, ½-2 standard drinks/day can be considered as moderate alcohol consumption. The interpretation of the J-shaped relationship has been criticized mainly due to potential confounding from the selected reference group and uncontrolled lifestyle factors. Longer, well-designed randomized controlled trials are lacking to infer causality and to clarify the mechanism of action for the acute and chronic effects of moderate alcohol consumption on cardiometabolic health and energy homeostasis. However, some aspects of alcohol metabolism and biomarker validation could inform such a study.
HotFacets is set to generate insight into the effects of acute alcohol intake on SCFA dynamics in blood, urine, and faeces; into the dose-response relationship with REE, thermogenesis, substrate oxidation, and alcohol biomarkers; and to explore potential low levels of alcohol produced in the gut.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
TRIPLE
Study Groups
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Treatment order A-.B-C-D
A: 5g ethanol-2-D3 mixed into 250ml water with added aromas of gin and lime juice B:10g ethanol-2-D3 mixed into 250ml water with added aromas of gin and lime juice C: 8g Triacetin mixed into 250ml water with added aromas of gin and lime juice D: 250ml water with added aromas of gin and lime juice
Ethanol
Crossover meal study
Treatment order B-D-A-C
A: 5g ethanol-2-D3 mixed into 250ml water with added aromas of gin and lime juice B:10g ethanol-2-D3 mixed into 250ml water with added aromas of gin and lime juice C: 8g Triacetin mixed into 250ml water with added aromas of gin and lime juice D: 250ml water with added aromas of gin and lime juice
Ethanol
Crossover meal study
Treatment order C-A-D-B
A: 5g ethanol-2-D3 mixed into 250ml water with added aromas of gin and lime juice B:10g ethanol-2-D3 mixed into 250ml water with added aromas of gin and lime juice C: 8g Triacetin mixed into 250ml water with added aromas of gin and lime juice D: 250ml water with added aromas of gin and lime juice
Ethanol
Crossover meal study
Treatment order D-C-B-A
A: 5g ethanol-2-D3 mixed into 250ml water with added aromas of gin and lime juice B:10g ethanol-2-D3 mixed into 250ml water with added aromas of gin and lime juice C: 8g Triacetin mixed into 250ml water with added aromas of gin and lime juice D: 250ml water with added aromas of gin and lime juice
Ethanol
Crossover meal study
Interventions
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Ethanol
Crossover meal study
Eligibility Criteria
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Inclusion Criteria
* Age: 50-75 years old
* BP ≤ 140/90 (systolic/diastolic)
* Plasma glucose \<7 mmol/l
* BMI: 18.5-27 kg/m2
* Subjects with a good command of both written and verbal English
* Healthy men and women
* Age: 25-75 years old
* BP ≤ 140/90 (systolic/diastolic)
* Plasma glucose \<7 mmol/l
* BMI: 18.5-27 kg/m2
* Willing to provide registration of compliance during the run-in period and follow-up periods
* Willing to avoid drinking alcohol for 2 weeks before the first test day and between test days
* Willing to stay in the respiration chamber the night before and after each test day
* Owning a smartphone
Exclusion Criteria
* Any history of alcohol or substance abuse or a high alcohol intake, defined as:
* An Alcohol Use Disorders Identification Test (AUDIT, appendix 1) score \> 5 at screening
* Drinking on average \>14 alcoholic beverages a week during the past 6 months
* Yale-Brown Obsessive Compulsive Scale-heavy drinking (Y-BOCS-hd, appendix 2) total score of ≥6 on questions 1, 2, and 3
* Intolerance or allergy to alcoholic beverages, juniper or citrus
* Diagnosed with any CVD event (MI, revascularization procedure or stroke) within the past six months
* Diagnosed with any known or past severe chronic disease including liver diseases (e.g., active hepatitis B and C infections, liver cirrhosis, hepatitis, cancer), T2DM, prediabetes, hypertension, severe psychiatric illness or frequent use of medication (except over-the-counter drugs or mild anti-depressants) or any other clinical condition that makes the subject ineligible according to the clinically responsible medical doctor (self-reported).
* Cancer - active malignant cancer or history of malignancy within the last 5 years (with exception of non-melanoma skin cancer).
* Previous breast cancer diagnosis or at high risk of breast cancer defined as:
* Breast Cancer Risk Assessment Tool (BCRAT) risk score \> 5 % (https://bcrisktool.cancer.gov/calculator.html)
* Close relatives with diagnosed breast cancer (mother, sister, daughter)
* A Patient Health Questionnaire (PHQ-9, appendix 3) ≥15 at screening or a positive response on question 9 (thoughts about suicide)
* Diagnosed with atrial fibrillation
* Hemoglobin (Hb) levels below 7.3 mmol/L for women and 8.3 mmol/L for men.
* Chronic use of any type of medication, except for mild antidepressants or contraceptives
* Any use of contraindicated medication for alcohol intake, such as disulfiram, dual antiplatelet therapy, metronidazole, warfarin or hormone replacement therapy
* Hypersensitive to plasters
* Use of any type of antibiotics within two month before the first test day
* Unintentional weight loss \>20% during the last 6 months
* Any type of gastrointestinal problems or prior surgery expected to influence gut health and absorption.
* Estimated glomerular filtration rate (eGFR) \< 30 ml/min/1.73 m2 or end-stage renal disease
* Liver function tests \>2 times the upper limit of the normal range according to current limits at "sundhed.dk": alanine transaminase (ALT), aspartate aminotransferase (AST), and gamma-glutamyltransferase (GGT).
* Blood donations within the past three months before the recruitment
* Having no hair on the head (bald-headed)
* Current participation in another trial
* Not willing to sign the Informed consent form (ICF)
* Not willing to comply with the all the trial procedures including completion of the two-week run-in periods without drinking alcohol as well the two-week wash-out periods
* Unable or unwilling to follow the safety procedures related to Covid19
* Any other issue that makes the project responsible researcher doubt the eligibility of the volunteer
25 Years
75 Years
ALL
Yes
Sponsors
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University of Copenhagen
OTHER
Responsible Party
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Professor Lars Ove Dragsted
Professor
Principal Investigators
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Lars O Dragsted, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Copenhagen
Locations
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Department of Nutrition, Exercise and Sports, University of Copenhagen
Copenhagen, Frederiksberg C, Denmark
Lars Ove Dragsted
Frederiksberg, , Denmark
Countries
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Central Contacts
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Facility Contacts
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Lars O Dragsted, Professor
Role: primary
Catalina Cuparencu, PhD
Role: backup
Lars O Dragsted
Role: primary
Other Identifiers
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M240
Identifier Type: -
Identifier Source: org_study_id