Mood Swings Clinical Trial
Official title:
The Effect of Moderate Alcohol Consumption With a Meal in Different Ambiances on Postprandial Mood, Evaluated by Subjective and Physiological Responses
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
| Status | Completed |
| Enrollment | 28 |
| Est. completion date | December 2011 |
| Est. primary completion date | December 2011 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Female |
| Age group | 18 Years to 45 Years |
| Eligibility |
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. |
Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science
| Country | Name | City | State |
|---|---|---|---|
| Netherlands | TNO | Zeist | Utrecht |
| Lead Sponsor | Collaborator |
|---|---|
| TNO |
Netherlands,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. | 5 times during study day, 4 study days (total 20x) | No |