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Effect of Moderate Alcohol Consumption on Postprandial Mood

Primary Purpose

Mood Swings

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Nutrition
mood manipulation
Sponsored by
TNO
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Mood Swings focused on measuring alcohol, mood, postprandial

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Healthy as assessed by the health and lifestyle questionnaire, (P9334 F02; in Dutch)
  • Females aged 18-45 years at Day 01 of the study
  • Taking a monophasic combined oral contraceptive pill at Day 01 of the study, with 21 days of taking pills with active ingredients followed by 7 days taking no pills or continuous intake of the oral contraceptive pill
  • Body Mass Index (BMI) of 18.5-27 kg/m2
  • Body weight between 57 and 80 kg
  • Normal Dutch eating habits as assessed by P9334 F02
  • Alcohol consumption ≥ 3 and ≤ 21 standard units/week
  • Voluntary participation
  • Having given written informed consent
  • Willing to comply with the study procedures, including refrain from alcohol 24 h before the test days and refrain from caffeine during the afternoon of the test day
  • Appropriate veins for blood sampling/cannula insertion according to TNO
  • Willing to accept use of all nameless data, including publication, and the confidential use and storage of all data for at least 15 years
  • Willing to accept the disclosure of the financial benefit of participation in the study to the authorities concerned

Exclusion Criteria:

  • Participation in any clinical trial including blood sampling and/or administration of substances up to 90 days before Day 01 of this study.
  • Having a history of medical or surgical events or disease that may significantly affect the study outcome, particularly physiological disorders, or psychiatric, metabolic or endocrine disease and gastrointestinal disorders.
  • Use of medication that may affect the outcome of the study parameters (e.g. antidepressive drugs).
  • Having a family history of alcoholism
  • Having a history of alcohol or drug related problems
  • Smoking
  • Reported unexplained weight loss or gain of > 2 kg in the month prior to the pre-study screening
  • Reported slimming or medically prescribed diet
  • Reported vegan, vegetarian or macrobiotic
  • Recent blood donation (<1 month prior to the start of the study)
  • Not willing to give up blood donation during the study.
  • Pregnant (to their own knowledge) or lactating or wishing to become pregnant in the period of the study
  • Personnel of TNO Zeist, their partner and their first and second degree relatives
  • Not having a general practitioner
  • Not willing to accept information-transfer concerning participation in the study, or information regarding her health, like laboratory results, findings at anamnesis or physical examination and eventual adverse events to and from his general practitioner.

Sites / Locations

  • TNO

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Alcohol

Ambiance

Arm Description

3 glasses of sparkling white wine (30g alcohol) with dinner 3 glasses of alcohol free sparkling white wine (<2g alcohol) with dinner

Pleasant ambiance Unpleasant ambiance

Outcomes

Primary Outcome Measures

Profile of mood states (POMS)
Difference between the change in the score of the 6 items of the POMS (after consumption of either white wine or alcohol free white wine with a meal in either a positive or negative ambiance. POMS will be measured before consumption, and 30min, 60min, 90min and 150min after consumption.

Secondary Outcome Measures

Full Information

First Posted
August 26, 2011
Last Updated
October 17, 2012
Sponsor
TNO
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1. Study Identification

Unique Protocol Identification Number
NCT01426022
Brief Title
Effect of Moderate Alcohol Consumption on Postprandial Mood
Official Title
The Effect of Moderate Alcohol Consumption With a Meal in Different Ambiances on Postprandial Mood, Evaluated by Subjective and Physiological Responses
Study Type
Interventional

2. Study Status

Record Verification Date
October 2012
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
TNO

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Rationale: Food choice is influenced by postprandial mood; the feelings of well-being after a meal. Postprandial mood can be measured by subjective responses. Physiological responses may play an important role in the generation of postprandial mood. However, the relationship between subjective and physiological responses after a meal is not clear yet. To investigate this relationship, moderate alcohol consumption will be used as a mood modulator, because of its well-studied effects on mood. Postprandial mood depends on the current mood state. Therefore the investigators will manipulate the current mood state by changing the ambiance to measure the influence of moderate alcohol consumption with a meal on postprandial mood in a pleasant or unpleasant ambiance. Objective: To determine whether moderate alcohol consumption with a meal in different ambiances affects postprandial mood, evaluated by subjective and physiological parameters. Study design: Randomized, placebo-controlled, single-blind, cross-over trial Study population: 28 apparently healthy, normal weight (BMI 18.5-27 kg/m2) women (18-45 y), taking oral contraceptives. Intervention: 4 times having dinner at TNO Zeist with either 3 glasses of sparkling white wine (~30g alcohol) or alcohol-free sparkling white wine in either a pleasant or unpleasant meal ambiance. Hypothesis: It is hypothesized that moderate alcohol consumption with a meal in different ambiances changes the response of subjective and physiological parameters of mood. Ho: there is no effect of alcohol consumption and ambiance on mood H1: there is an effect of alcohol consumption and ambiance on mood

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mood Swings
Keywords
alcohol, mood, postprandial

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Alcohol
Arm Type
Placebo Comparator
Arm Description
3 glasses of sparkling white wine (30g alcohol) with dinner 3 glasses of alcohol free sparkling white wine (<2g alcohol) with dinner
Arm Title
Ambiance
Arm Type
Experimental
Arm Description
Pleasant ambiance Unpleasant ambiance
Intervention Type
Other
Intervention Name(s)
Nutrition
Other Intervention Name(s)
Alcohol, Ethanol, Wine
Intervention Description
Moderate alcohol consumption with dinner (3 glasses of sparkling white wine, containing ca. 30 g alcohol)
Intervention Type
Behavioral
Intervention Name(s)
mood manipulation
Other Intervention Name(s)
Ambience, Ambiance, Positive affect, Emotion
Intervention Description
Mood will be manipulated by changing the ambiance in either a pleasant or unpleasant way.
Primary Outcome Measure Information:
Title
Profile of mood states (POMS)
Description
Difference between the change in the score of the 6 items of the POMS (after consumption of either white wine or alcohol free white wine with a meal in either a positive or negative ambiance. POMS will be measured before consumption, and 30min, 60min, 90min and 150min after consumption.
Time Frame
5 times during study day, 4 study days (total 20x)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy as assessed by the health and lifestyle questionnaire, (P9334 F02; in Dutch) Females aged 18-45 years at Day 01 of the study Taking a monophasic combined oral contraceptive pill at Day 01 of the study, with 21 days of taking pills with active ingredients followed by 7 days taking no pills or continuous intake of the oral contraceptive pill Body Mass Index (BMI) of 18.5-27 kg/m2 Body weight between 57 and 80 kg Normal Dutch eating habits as assessed by P9334 F02 Alcohol consumption ≥ 3 and ≤ 21 standard units/week Voluntary participation Having given written informed consent Willing to comply with the study procedures, including refrain from alcohol 24 h before the test days and refrain from caffeine during the afternoon of the test day Appropriate veins for blood sampling/cannula insertion according to TNO Willing to accept use of all nameless data, including publication, and the confidential use and storage of all data for at least 15 years Willing to accept the disclosure of the financial benefit of participation in the study to the authorities concerned Exclusion Criteria: Participation in any clinical trial including blood sampling and/or administration of substances up to 90 days before Day 01 of this study. Having a history of medical or surgical events or disease that may significantly affect the study outcome, particularly physiological disorders, or psychiatric, metabolic or endocrine disease and gastrointestinal disorders. Use of medication that may affect the outcome of the study parameters (e.g. antidepressive drugs). Having a family history of alcoholism Having a history of alcohol or drug related problems Smoking Reported unexplained weight loss or gain of > 2 kg in the month prior to the pre-study screening Reported slimming or medically prescribed diet Reported vegan, vegetarian or macrobiotic Recent blood donation (<1 month prior to the start of the study) Not willing to give up blood donation during the study. Pregnant (to their own knowledge) or lactating or wishing to become pregnant in the period of the study Personnel of TNO Zeist, their partner and their first and second degree relatives Not having a general practitioner Not willing to accept information-transfer concerning participation in the study, or information regarding her health, like laboratory results, findings at anamnesis or physical examination and eventual adverse events to and from his general practitioner.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Henk Hendriks, PhD
Organizational Affiliation
TNO
Official's Role
Principal Investigator
Facility Information:
Facility Name
TNO
City
Zeist
State/Province
Utrecht
ZIP/Postal Code
3704
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
25962070
Citation
Schrieks IC, Ripken D, Stafleu A, Witkamp RF, Hendriks HF. Effects of mood inductions by meal ambiance and moderate alcohol consumption on endocannabinoids and N-acylethanolamines in humans: a randomized crossover trial. PLoS One. 2015 May 11;10(5):e0126421. doi: 10.1371/journal.pone.0126421. eCollection 2015.
Results Reference
derived
PubMed Identifier
24465955
Citation
Schrieks IC, Stafleu A, Kallen VL, Grootjen M, Witkamp RF, Hendriks HF. The biphasic effects of moderate alcohol consumption with a meal on ambiance-induced mood and autonomic nervous system balance: a randomized crossover trial. PLoS One. 2014 Jan 21;9(1):e86199. doi: 10.1371/journal.pone.0086199. eCollection 2014.
Results Reference
derived

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Effect of Moderate Alcohol Consumption on Postprandial Mood

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