Human Auto-ethanol Formation and Acetate Signaling

Launched by UNIVERSITY OF COPENHAGEN · Nov 10, 2021

Keywords

ClinConnect Summary

The HotFacets study is a research trial that looks at how drinking alcohol affects the body, particularly how it influences certain types of fats in the blood and energy use. The study aims to better understand the effects of moderate alcohol consumption on health, especially regarding heart disease and diabetes. Researchers are interested in learning how drinking alcohol impacts short-chain fatty acids (which are important for our health) and other biological markers in healthy adults.

To participate in this trial, you need to be a healthy adult between the ages of 25 and 75 years. Specific criteria include having normal blood pressure, a healthy body weight, and no recent history of alcohol abuse. Participants will be required to avoid alcohol for two weeks before the study days and will spend time in a special chamber to monitor their breathing and energy use. This study aims to provide new insights into how moderate alcohol consumption might affect health, so if you meet the criteria and are interested, you could help contribute to important health research!

Gender

ALL

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