Investigating the effects of alcohol on metabolism and health markers

Human Auto-ethanol Formation and Acetate Signaling. Acute Effects of Alcohol on Short-chain Fatty Acid Dynamics and Energy Metabolism in Healthy Men and Women.

This study is testing how drinking moderate amounts of alcohol affects metabolism and health markers in healthy people to see if it has any benefits for heart health and diabetes.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 24 (estimated)
• Ages: 25 Years to 75 Years
• Sex: All
• Sponsor: University of Copenhagen (Academic / other)
• Locations: 2 sites (Copenhagen, Frederiksberg C and 1 other locations)
• Trial ID: NCT05130619 on ClinicalTrials.gov

What this trial studies

This study is a randomized, controlled, cross-over meal investigation that examines how moderate alcohol consumption affects short-chain fatty acids, energy metabolism, and various health biomarkers in healthy individuals. Participants will undergo a series of tests involving placebo and different doses of ethanol, with metabolic measurements taken before, during, and after consumption. The study aims to clarify the relationship between moderate alcohol intake and its potential health benefits, particularly concerning cardiovascular diseases and Type 2 Diabetes Mellitus. A total of 24 healthy subjects will be involved, with specific age groups targeted for the pre-trial and main trial phases.

Who should consider this trial

Good fit: Ideal candidates are healthy men and women aged 25-75 years, with specific health criteria including normal blood pressure and glucose levels.

Not a fit: Patients with chronic health conditions or those who do not meet the eligibility criteria, such as individuals with high blood pressure or abnormal glucose levels, may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide insights into how moderate alcohol consumption may positively influence metabolic health and reduce the risk of certain diseases.

How similar studies have performed: While the relationship between moderate alcohol consumption and health outcomes has been observed in observational studies, this randomized controlled approach is relatively novel and aims to provide clearer causal insights.

Eligibility criteria

Subjects will be recruited to the trial in two seasons. First, eight healthy men and post-menopausal women 50-75 years will be recruited for the pre-trial during autumn/winter 2021. Secondly, 16 healthy men and women with an age-range of 25-75 years will be recruited for the main trial during late spring/summer 2022.

Age-specific inclusion criteria for the pre-trial:

* Healthy men and healthy, post-menopausal women (12 consecutive months without menstrual period)
* 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

Age-specific inclusion criteria for the main-trial:

* 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

Inclusion criteria for the pre- and main-trial:

* 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:

* Alcohol naïve or has not consumed alcohol within the last year
* 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

Where this trial is running

Copenhagen, Frederiksberg C and 1 other locations

• Department of Nutrition, Exercise and Sports, University of Copenhagen — Copenhagen, Frederiksberg C, Denmark (Recruiting)
• Lars Ove Dragsted — Frederiksberg, Denmark (Recruiting)

Study contacts

• Principal investigator: Lars O Dragsted, PhD — University of Copenhagen
• Study coordinator: Lars Ove Dragsted, PhD

Conditions Healthy