Effect of Moderate Alcohol Consumption on Postprandial Mood

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Henk FJ Hendriks, TNO Quality of Life
ClinicalTrials.gov Identifier:
NCT01426022
First received: August 26, 2011
Last updated: October 17, 2012
Last verified: October 2012
  Purpose

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

Condition Intervention
Mood Swings
Other: Nutrition
Behavioral: mood manipulation

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Basic Science
Official Title: The Effect of Moderate Alcohol Consumption With a Meal in Different Ambiances on Postprandial Mood, Evaluated by Subjective and Physiological Responses

Resource links provided by NLM:


Further study details as provided by TNO:

Primary Outcome Measures:
  • Profile of mood states (POMS) [ Time Frame: 5 times during study day, 4 study days (total 20x) ] [ Designated as safety issue: No ]
    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.


Enrollment: 28
Study Start Date: October 2011
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Alcohol
  1. 3 glasses of sparkling white wine (30g alcohol) with dinner
  2. 3 glasses of alcohol free sparkling white wine (<2g alcohol) with dinner
Other: Nutrition
Moderate alcohol consumption with dinner (3 glasses of sparkling white wine, containing ca. 30 g alcohol)
Other Names:
  • Alcohol
  • Ethanol
  • Wine
Experimental: Ambiance
  1. Pleasant ambiance
  2. Unpleasant ambiance
Behavioral: mood manipulation
Mood will be manipulated by changing the ambiance in either a pleasant or unpleasant way.
Other Names:
  • Ambience
  • Ambiance
  • Positive affect
  • Emotion

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01426022

Locations
Netherlands
TNO
Zeist, Utrecht, Netherlands, 3704
Sponsors and Collaborators
TNO
Investigators
Principal Investigator: Henk Hendriks, PhD TNO
  More Information

No publications provided by TNO

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Henk FJ Hendriks, PhD, TNO Quality of Life
ClinicalTrials.gov Identifier: NCT01426022     History of Changes
Other Study ID Numbers: P9334
Study First Received: August 26, 2011
Last Updated: October 17, 2012
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by TNO:
alcohol
mood
postprandial

Additional relevant MeSH terms:
Alcohol Drinking
Drinking Behavior
Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Central Nervous System Depressants
Physiological Effects of Drugs
Central Nervous System Agents

ClinicalTrials.gov processed this record on August 28, 2014