Identification of Biomarkers for Acute Intake of Beer and Alcohol and Acute Effects on Plasma and Insulin Response

NCT02449577 | Completed Early Phase 1 DMC

• 1 other identifier: M212
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of the study is to identify biomarkers for acute intake of beer and alcohol in individuals with a high or low habitual intake. Furthermore, we wish to identify compounds and metabolites in different types of beer and alcohol, which can serve as compliance markers for intake under the test conditions (blood tests and urine samples). We also wish to determine the acute effects of these beverages on plasma glucose and insulin response, compared to regular soda.

Conditions

Alcohol Consumption; Insulin Resistance

Keywords

Metabolomics; Beer; Biomarker; Glucose response; Insulin response

Outcome Measures

Primary Outcomes (1)

• Area under the curve (AUC) for glucose

  Glucose is measured at 0, 45, 90, 120, and 180 min after the test meal and the area is determined by the trapezoid method.

  0-180 minutes

Secondary Outcomes (12)

• Area under the curve for insulin

  0-180 min

• Plasma concentration of fatty acid ethyl esters (FAEE)

  Change from 0-180min

• Blood level of ethanol

  180 min

• Plasma beer metabolites (metabolic profiling with NMR and mass spectrometry).

  After the intervention

• Urinary content of paraaminobenzoic acid (PABA)

  24hour pooled urine from each volunteer

Study Arms (11)

Beverage sequence ABCD

EXPERIMENTAL

Each participant randomized to this arm is exposed to 4 test meals in the order ABCD with a washout period of at least a week between each meal. Each meal consisted of a standardized lunch of Parisian toast (sandwichbread, ham, cheese) together with a beverage. Each beverage is assigned a letter, A, B, C, or D. The letter assignment is blinded. The following four drinks were used Placebo: 330 ml of a soft drink (Sports drink), Beer 1 - 330 ml of an alcohol-free beer (\<0.1% alcohol), Beer 2 - 330 ml of a regular lager beer (4.6% alcohol), and Beer 3 - 330 ml of a strong beer (7.2% alcohol)

Other: Beverage sequence ABCD

Beverage sequence CADB

EXPERIMENTAL

Each participant randomized to this arm is exposed to 4 test meals in the order CADB with a washout period of at least a week between each meal. Each meal consisted of a standardized lunch of Parisian toast (sandwichbread, ham, cheese) together with a beverage. Each beverage is assigned a letter, A, B, C, or D. The letter assignment is blinded. The following four drinks were used Placebo: 330 ml of a soft drink (Sports drink), Beer 1 - 330 ml of an alcohol-free beer (\<0.1% alcohol), Beer 2 - 330 ml of a regular lager beer (4.6% alcohol), and Beer 3 - 330 ml of a strong beer (7.2% alcohol)

Other: Beverage sequence CADB

Beverage sequence DACB

EXPERIMENTAL

Each participant randomized to this arm is exposed to 4 test meals in the order DACB with a washout period of at least a week between each meal. Each meal consisted of a standardized lunch of Parisian toast (sandwichbread, ham, cheese) together with a beverage. Each beverage is assigned a letter, A, B, C, or D. The letter assignment is blinded. The following four drinks were used Placebo: 330 ml of a soft drink (Sports drink), Beer 1 - 330 ml of an alcohol-free beer (\<0.1% alcohol), Beer 2 - 330 ml of a regular lager beer (4.6% alcohol), and Beer 3 - 330 ml of a strong beer (7.2% alcohol)

Other: Beverage sequence DACB

Beverage sequence CBAD

EXPERIMENTAL

Each participant randomized to this arm is exposed to 4 test meals in the order CBAD with a washout period of at least a week between each meal. Each meal consisted of a standardized lunch of Parisian toast (sandwichbread, ham, cheese) together with a beverage. Each beverage is assigned a letter, A, B, C, or D. The letter assignment is blinded. The following four drinks were used Placebo: 330 ml of a soft drink (Sports drink), Beer 1 - 330 ml of an alcohol-free beer (\<0.1% alcohol), Beer 2 - 330 ml of a regular lager beer (4.6% alcohol), and Beer 3 - 330 ml of a strong beer (7.2% alcohol)

Other: Beverage sequence CBAD

Beverage sequence ABDC

EXPERIMENTAL

Each participant randomized to this arm is exposed to 4 test meals in the order ABDC with a washout period of at least a week between each meal. Each meal consisted of a standardized lunch of Parisian toast (sandwichbread, ham, cheese) together with a beverage. Each beverage is assigned a letter, A, B, C, or D. The letter assignment is blinded. The following four drinks were used Placebo: 330 ml of a soft drink (Sports drink), Beer 1 - 330 ml of an alcohol-free beer (\<0.1% alcohol), Beer 2 - 330 ml of a regular lager beer (4.6% alcohol), and Beer 3 - 330 ml of a strong beer (7.2% alcohol)

Other: Beverage sequence ABDC

Beverage sequence DABC

EXPERIMENTAL

Each participant randomized to this arm is exposed to 4 test meals in the order DABC with a washout period of at least a week between each meal. Each meal consisted of a standardized lunch of Parisian toast (sandwichbread, ham, cheese) together with a beverage. Each beverage is assigned a letter, A, B, C, or D. The letter assignment is blinded. The following four drinks were used Placebo: 330 ml of a soft drink (Sports drink), Beer 1 - 330 ml of an alcohol-free beer (\<0.1% alcohol), Beer 2 - 330 ml of a regular lager beer (4.6% alcohol), and Beer 3 - 330 ml of a strong beer (7.2% alcohol)

Other: Beverage sequence DABC

Beverage sequence DCAB

EXPERIMENTAL

Each participant randomized to this arm is exposed to 4 test meals in the order DCAB with a washout period of at least a week between each meal. Each meal consisted of a standardized lunch of Parisian toast (sandwichbread, ham, cheese) together with a beverage. Each beverage is assigned a letter, A, B, C, or D. The letter assignment is blinded. The following four drinks were used Placebo: 330 ml of a soft drink (Sports drink), Beer 1 - 330 ml of an alcohol-free beer (\<0.1% alcohol), Beer 2 - 330 ml of a regular lager beer (4.6% alcohol), and Beer 3 - 330 ml of a strong beer (7.2% alcohol)

Other: Beverage sequence DCAB

Beverage sequence DBCA

EXPERIMENTAL

Each participant randomized to this arm is exposed to 4 test meals in the order DBCA with a washout period of at least a week between each meal. Each meal consisted of a standardized lunch of Parisian toast (sandwichbread, ham, cheese) together with a beverage. Each beverage is assigned a letter, A, B, C, or D. The letter assignment is blinded. The following four drinks were used Placebo: 330 ml of a soft drink (Sports drink), Beer 1 - 330 ml of an alcohol-free beer (\<0.1% alcohol), Beer 2 - 330 ml of a regular lager beer (4.6% alcohol), and Beer 3 - 330 ml of a strong beer (7.2% alcohol)

Other: Beverage sequence DBCA

Beverage sequence ADCB

EXPERIMENTAL

Each participant randomized to this arm is exposed to 4 test meals in the order ADCB with a washout period of at least a week between each meal. Each meal consisted of a standardized lunch of Parisian toast (sandwichbread, ham, cheese) together with a beverage. Each beverage is assigned a letter, A, B, C, or D. The letter assignment is blinded. The following four drinks were used Placebo: 330 ml of a soft drink (Sports drink), Beer 1 - 330 ml of an alcohol-free beer (\<0.1% alcohol), Beer 2 - 330 ml of a regular lager beer (4.6% alcohol), and Beer 3 - 330 ml of a strong beer (7.2% alcohol)

Other: Beverage sequence ADCB

Beverage sequence BADC

EXPERIMENTAL

Each participant randomized to this arm is exposed to 4 test meals in the order BADC with a washout period of at least a week between each meal. Each meal consisted of a standardized lunch of Parisian toast (sandwichbread, ham, cheese) together with a beverage. Each beverage is assigned a letter, A, B, C, or D. The letter assignment is blinded. The following four drinks were used Placebo: 330 ml of a soft drink (Sports drink), Beer 1 - 330 ml of an alcohol-free beer (\<0.1% alcohol), Beer 2 - 330 ml of a regular lager beer (4.6% alcohol), and Beer 3 - 330 ml of a strong beer (7.2% alcohol)

Other: Beverage sequence BADC

Beverage sequence ACDB

EXPERIMENTAL

Each participant randomized to this arm is exposed to 4 test meals in the order ACDB with a washout period of at least a week between each meal. Each meal consisted of a standardized lunch of Parisian toast (sandwichbread, ham, cheese) together with a beverage. Each beverage is assigned a letter, A, B, C, or D. The letter assignment is blinded. The following four drinks were used Placebo: 330 ml of a soft drink (Sports drink), Beer 1 - 330 ml of an alcohol-free beer (\<0.1% alcohol), Beer 2 - 330 ml of a regular lager beer (4.6% alcohol), and Beer 3 - 330 ml of a strong beer (7.2% alcohol)

Other: Beverage sequence ACDB

Interventions

Beverage sequence ABCD OTHER

Participants receive test beverages in the randomised order ABCD

Beverage sequence ABCD

Beverage sequence CADB OTHER

Participants receive test beverages in the randomised order CADB

Beverage sequence CADB

Beverage sequence DACB OTHER

Participants receive test beverages in the randomised order DACB

Beverage sequence DACB

Beverage sequence CBAD OTHER

Participants receive test beverages in the randomised order CBAD

Beverage sequence CBAD

Beverage sequence ABDC OTHER

Participants receive test beverages in the randomised order ABDC

Beverage sequence ABDC

Beverage sequence DABC OTHER

Participants receive test beverages in the randomised order DABC

Beverage sequence DABC

Beverage sequence DCAB OTHER

Participants receive test beverages in the randomised order DCAB

Beverage sequence DCAB

Beverage sequence DBCA OTHER

Participants receive test beverages in the randomised order BDCA

Beverage sequence DBCA

Beverage sequence ADCB OTHER

Participants receive test beverages in the randomised order ADCB

Beverage sequence ADCB

Beverage sequence BADC OTHER

Participants receive test beverages in the randomised order BADC

Beverage sequence BADC

Beverage sequence ACDB OTHER

Participants receive test beverages in the randomised order ACDB

Beverage sequence ACDB

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy man or woman in the age group 18-60 years
• Likes and tolerates pasta, tomatoes and cheese, and is not a vegetarian or vegan, since meat (beef and pork) is included in the standardized dinner, breakfast and in the test meal
• Habitual alcohol intake (high: up to 7/14 units per week for women/men) or low: 0-2 units per week for both genders
• Tolerates alcohol

You may not qualify if:

• Systematic infections, psychiatric conditions and metabolic disease, and any clinical condition and other condition/situation, which according to the experimenter's assessment makes the person unfit to participate in the study
• Donation of a larger amount of blood (more than 24 ml) e.g. in connection with donation or other scientific research study, during the study and 3 months before start of the study
• Alcohol intake above the Danish Health and Medicines Authority's recommended 7 respective 14 drinks (units) per week for women and men
• Have or have had a drug addiction
• Allergy or intolerance to any of the tested drinks, or to any other foods included in the study. The participant will be specifically screened for possible alcohol allergy or intolerance
• Nursing, pregnancy or planned pregnancy.
• Not capable of complying with the procedures stipulated in the protocol.

Sponsors & Collaborators

• University of Copenhagen: lead
• Carlsberg Breweries A/S: collaborator

Study Sites (1)

Department of Nutrition, Exercise and Sports, University of Copenhagen

Frederiksberg C, 1958, Denmark

Location

MeSH Terms

Conditions

Alcohol Drinking; Insulin Resistance

Condition Hierarchy (Ancestors)

Drinking Behavior; Behavior; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Lars O. Dragsted, Professor

  Department of Nutrition, Exercise and Sports, University of Copenhagen, Rolighedsvej 30, 1958 Frederiksberg C, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 28, 2013
• First Posted: May 20, 2015
• Study Start: May 1, 2013
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: May 20, 2015

Record last verified: 2015-05

Locations

DK (1)