Metabolic Imprints of Alcoholic Beverages

NCT03384147 | Completed

• 1 other identifier: M228
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

Metabolic imprints of five different types of alcohol will be investigated in two study groups. The study will be an assessor-blinded, parallel dietary trial (crossover design). The project aims to identify the chemical nature and kinetics of metabolite changes related to alcohol, hops, grapes and other beverage constituents as well as the brewing processes.

Conditions

Metabolic Side Effects of Drugs and Substances

Outcome Measures

Primary Outcomes (1)

• DHEAS

  Changes in dehydroepiandrosterone sulphate (DHEAS) and related (steroid) hormones and metabolites

  3 weeks

Secondary Outcomes (12)

• Markers of alcohol intake

  3 weeks

• Human microbial co-metabolites

  3 weeks

• Markers of intake of raw materials from the beverage productions

  1 day

• Metabolites from outcomes 1-4 measured in dry urine spots

  1 day

• Metabolites from outcomes 1-4 measured in dry blood samples

  1 day

Other Outcomes (2)

• Discriminant metabolic profiles

  3 weeks

• Discriminant metabolic profiles

  4-5 days

Study Arms (2)

Drinking

EXPERIMENTAL

Occasional drinkers assigned to start with a 3week drinking period (women 1 u/day - men 2 u/day) Followed by crossover without washout to 3 week abstaining period

Dietary Supplement: Drinking; Other: Abstaining

Abstaining

EXPERIMENTAL

Habitual drinkers assigned to start 2 weeks of abstaining from alcohol Followed by crossover without washout to 3 weeks drinking (women 1 u/day - men 2 u/day)

Dietary Supplement: Drinking; Other: Abstaining

Interventions

Drinking DIETARY_SUPPLEMENT

Five different types of alcohol given to participants for 4-5 days in a random sequence for 3 weeks

Abstaining; Drinking

Abstaining OTHER

Participants are abstaining from all alcoholic beverages for three weeks

Abstaining; Drinking

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age
• No intolerance of alcohol
• Experience with alcohol
• Able to use smartphone or tablet

You may not qualify if:

• Serious chronic health conditions or psychiatric diseases
• Chronic intake of medicine (beside birth control and SSRI)
• Alcohol and/or drug abuse assessed AUDIT score \>4 (AUDIT = Alcohol Use Disorders Identification Test).
• Blood samples/donations during trial and 3 months prior
• Liver dysfunction
• High risk of breast cancer assessed by BCRAT score (BCRAT = The Breast Cancer Risk Assessment Tool)
• Pregnancy or lactating

Sponsors & Collaborators

• University of Copenhagen: lead
• Carlsberg Foundation: collaborator

Study Sites (1)

Department of Nutrition, Exercise and Sports, University of Copenhagen

Copenhagen, Frederiksberg C, 1958, Denmark

Location

Related Publications (1)

• Wilkens TL, Ziegler Z, Aru V, Khakimov B, Overgaard SL, Engelsen SB, Dragsted LO. 1-2 Drinks Per Day Affect Lipoprotein Composition after 3 Weeks-Results from a Cross-Over Pilot Intervention Trial in Healthy Adults Using Nuclear Magnetic Resonance-Measured Lipoproteins and Apolipoproteins. Nutrients. 2022 Nov 27;14(23):5043. doi: 10.3390/nu14235043.

  PMID: 36501072 DERIVED

MeSH Terms

Conditions

Metabolic Side Effects of Drugs and Substances

Interventions

Drinking

Condition Hierarchy (Ancestors)

Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Eating; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Digestive System Physiological Phenomena; Digestive System and Oral Physiological Phenomena

Study Officials

• Lars O Dragsted, PhD

  University of Copenhagen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: Intake of alcoholic drinks or abstaining cannot be masked to participants or care providers (delivering the alcoholic beverages). The outcomes included biomarkers of alcohol intake so in practice the investigator and outcomes assessor could not be blinded either.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Head of Section

Model Details: The study was conducted in two predefined groups of volunteers, 1) daily alcohol users of maximally one (females) or two (males) drinks per day, and 2) occasional drinkers (0-2 drinks per week). Group 1 was asked to abstain from alcohol for 3 weeks, then to resume drinking 1-2 drinks daily for the next three weeks. Group 2 was asked to drink 1-2 drinks daily for 3 weeks and then to abstain for the following 3 weeks. During the alcohol intake period both groups were randomized to sequences of 4-5 days with red wine, white wine, lager beer, apple cider, or spirits. The primary endpoint was an effect of alcohol on dihydroepiandrosterone sulphate excretion in urine. Biomarkers of alcohol intake and alcohol-induced metabolic change, physical activity, or well-being were secondary outcomes.

Study Record Dates

• First Submitted: December 11, 2017
• First Posted: December 27, 2017
• Study Start: January 13, 2016
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2017
• Last Updated: December 27, 2017

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 3-6 months after publication of data in a peer reviewed journal when the study has been fully anonymized.
• Access Criteria: Through the web-site, https://enpadasi.science.ku.dk/

Locations

DK (1)