Clinical trial NCT01426022: 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
Overall status: COMPLETED
Phase: NA
Conditions: Mood Swings
Keywords: alcohol
mood
postprandial
Lead sponsor: TNO
Sponsor class: OTHER
First posted: 2011-08-30
Enrollment: 28
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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


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.

Primary outcomes:
measure: Profile of mood states (POMS)
timeFrame: 5 times during study day, 4 study days (total 20x)
Secondary outcomes:
Other outcomes:
Locations:
city: Zeist
country: Netherlands
facility: TNO
state: Utrecht
Study officials:
affiliation: TNO
name: Henk Hendriks, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.