Effect of Moderate Alcohol Consumption on Postprandial Mood

NCT01426022 | Completed

• 1 other identifier: P9334
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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 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

Conditions

Mood Swings

Keywords

alcohol; mood; postprandial

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (2)

Alcohol

PLACEBO COMPARATOR

1. 3 glasses of sparkling white wine (30g alcohol) with dinner 2. 3 glasses of alcohol free sparkling white wine (\<2g alcohol) with dinner

Other: Nutrition

Ambiance

EXPERIMENTAL

1. Pleasant ambiance 2. Unpleasant ambiance

Behavioral: mood manipulation

Interventions

Nutrition OTHER

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

Also known as: Alcohol, Ethanol, Wine

Alcohol

mood manipulation BEHAVIORAL

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

Also known as: Ambience, Ambiance, Positive affect, Emotion

Ambiance

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• TNO: lead

Study Sites (1)

TNO

Zeist, Utrecht, 3704, Netherlands

Location

Related Publications (2)

• 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.

  PMID: 25962070 DERIVED

• 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.

  PMID: 24465955 DERIVED

MeSH Terms

Interventions

Nutritional Status; Ethanol; Wine

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Health Status; Demography; Population Characteristics; Alcohols; Organic Chemicals; Alcoholic Beverages; Beverages; Fermented Beverages; Fermented Foods; Food and Beverages

Study Officials

• Henk Hendriks, PhD

  TNO

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: August 26, 2011
• First Posted: August 30, 2011
• Study Start: October 1, 2011
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: October 18, 2012

Record last verified: 2012-10

Locations

NL (1)