The effect of moderate alcohol consumption with a meal in different ambiances on postprandial mood, evaluated by subjective and objective responses.

Completed

• Conditions: stemmingswisselingen; mood fluctuations; 10024450

• Registration Number: NL-OMON35204
• Lead Sponsor: Stichting Alcohol Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 28

Inclusion Criteria

9.4 Inclusion criteria
1. Healthy as assessed by the health and lifestyle questionnaire, (P9334 F02; in Dutch).
2. Females aged 18-45 years at Day 01 of the study*
3. 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**.
4. Body Mass Index (BMI) of 18.5-27 kg/m2 *
5. Body weight between 57 and 80 kg
6. Normal Dutch eating habits as assessed by P9334 F02
7. Alcohol consumption >= 3 and <= 21 standard units/week*
8. Voluntary participation
9. Having given written informed consent
10. 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.
11. Appropriate veins for blood sampling/cannula insertion according to TNO
12. Willing to accept use of all nameless data, including publication, and the confidential use and storage of all data for at least 15 years
13. Willing to accept the disclosure of the financial benefit of participation in the study to the authorities concerned.;* Volunteers within the age of 25-45 years, a BMI of 20-25 and with an alcohol consumption between 3-14 standard glasses/week are preferred for inclusion.
** With the recruitment letter, a list with accepted brands of oral contraceptive pills for participation will be added.

Exclusion Criteria

9.5 Exclusion criteria
Subjects with one or more of the following characteristics will be excluded from participation:
1. Participation in any clinical trial including blood sampling and/or administration of substances up to 90 days before Day 01 of this study.
2. 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.
3. Use of medication that may affect the outcome of the study parameters (e.g. antidepressive drugs).
4. Having a family history of alcoholism
5. Having a history of alcohol or drug related problems
6. Smoking
7. Reported unexplained weight loss or gain of > 2 kg in the month prior to the pre-study screening
8. Reported slimming or medically prescribed diet
9. Reported vegan, vegetarian or macrobiotic
10. Recent blood donation (<1 month prior to the start of the study)
11. Not willing to give up blood donation during the study.
12. Pregnant (to their own knowledge) or lactating or wishing to become pregnant in the period of the study
13. Personnel of TNO Zeist, their partner and their first and second degree relatives
14. Not having a general practitioner
15. 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Subjective response:<br /><br>- POMS (extended with mood scales happiness and calmness)<br /><br>- Brief BAES<br /><br>- Postprandial wellness (PPW) questionnaire<br /><br><br /><br>Physiological response:<br /><br>- Stress hormones (ACTH and cortisol)<br /><br>- Serotonin system (Trp:LNAA ratio)<br /><br>- Satiety hormone (ghrelin)</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Physiological response:<br /><br>- Endocannabinoids and N-acyl serotonins<br /><br>- &beta;-endorphin plasma levels<br /><br>- dopamine plasma levels<br /><br>- Satiety hormones (Insulin, CCK and GLP-1).<br /><br>- Metabolites (FFA and glucose)<br /><br>- Non-invasive measures (Heart rate, HRV and SCL)</p><br>