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Completed

NCT Number: NCT01426022

Effect of Moderate Alcohol Consumption on Postprandial Mood

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

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Key information

Conditions

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

TNO

Zeist, Utrecht, 3704, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Nutrition

Other

Moderate alcohol consumption with dinner (3 glasses of sparkling white wine, containing ca. 30 g alcohol)

Other names: Alcohol, Ethanol, Wine

mood manipulation

Behavioral

Mood will be manipulated by changing the ambiance in either a pleasant or unpleasant way.

Other names: Ambience, Ambiance, Positive affect, Emotion

Primary outcomes

  1. Profile of mood states (POMS)

    Time frame: 5 times during study day, 4 study days (total 20x)

    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.

Sponsors and collaborators

Lead sponsor

TNO

Other

Registry information

Official study title

The Effect of Moderate Alcohol Consumption With a Meal in Different Ambiances on Postprandial Mood, Evaluated by Subjective and Physiological Responses

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Aug 30, 2011
Registry last updated
Oct 18, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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