Effect of Moderate Alcohol Consumption on Postprandial Mood
NCT ID: NCT01426022
Last Updated: 2012-10-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
28 participants
INTERVENTIONAL
2011-10-31
2011-12-31
Brief Summary
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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
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
SINGLE
Study Groups
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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
Nutrition
Moderate alcohol consumption with dinner (3 glasses of sparkling white wine, containing ca. 30 g alcohol)
Ambiance
1. Pleasant ambiance
2. Unpleasant ambiance
mood manipulation
Mood will be manipulated by changing the ambiance in either a pleasant or unpleasant way.
Interventions
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Nutrition
Moderate alcohol consumption with dinner (3 glasses of sparkling white wine, containing ca. 30 g alcohol)
mood manipulation
Mood will be manipulated by changing the ambiance in either a pleasant or unpleasant way.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
45 Years
FEMALE
Yes
Sponsors
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TNO
OTHER
Responsible Party
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Henk FJ Hendriks
PhD
Principal Investigators
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Henk Hendriks, PhD
Role: PRINCIPAL_INVESTIGATOR
TNO
Locations
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TNO
Zeist, Utrecht, Netherlands
Countries
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References
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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.
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.
Other Identifiers
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P9334
Identifier Type: -
Identifier Source: org_study_id