Status:
COMPLETED
Effect of Moderate Alcohol Consumption on Postprandial Mood
Lead Sponsor:
TNO
Conditions:
Mood Swings
Eligibility:
FEMALE
18-45 years
Phase:
NA
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 impor...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT01426022
Start Date
October 1 2011
End Date
December 1 2011
Last Update
October 18 2012
Active Locations (1)
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1
TNO
Zeist, Utrecht, Netherlands, 3704