NCT05130619

Human Auto-ethanol Formation and Acetate Signaling

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.

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: University of Copenhagen · Academic / Other
• Sex: All
• Age: 25 Years – 75 Years
• Healthy volunteers: Accepted

Summary

The HotFacets study is a randomized, controlled, cross-over meal study that investigates the acute effects of alcohol consumption on short-chain fatty acids dynamics, energy metabolism, and biomarkers. 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

A randomized, controlled, four times cross-over, single-blinded, meal study with 24 healthy fasting subjects will be conducted with a) placebo (water), b) a metabolic acetate generator (triacetin), and c) a half or d) one unit of isotope labelled ethanol, provided in a randomized order. Volunteers will be confined in a metabolic chamber overnight before each test drink (in 250mL water with lemon and juniper taste) and energy production and expenditure will be measured initially using seven ventilated hood measurements. After the test drinks and ventilated hood measurements an ad libitum lunch will be served before the participants will be admitted to the metabolic chamber, where metabolic measurements will be continued until the following day. Participants will go through a 2-week run-in period before each test drink and a 2-week wash out period afterwards, both with alcohol abstention. From two days before the test day in each period until one day after the test days, standardized foods will be provided. Anthropometrics, DXA, heart rate, blood pressure and all movements will be recorded before and/or during the test days. Before, during, and after the test day repeated biological samples (i.e., urine, blood, feces, hair) will be collected. The study will be divided into a pre-trial (8 subjects, 50-75y) and a main trial (16 subjects, 25-75y).

Conditions

• Healthy

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Ethanol	Crossover meal study

Timeline

• Start date: 2021-11-10
• Primary completion: 2024-04-01
• Completion: 2024-12-01
• First posted: 2021-11-23
• Last updated: 2023-11-30

Locations

2 sites across 1 country: Denmark