Mood SwingsNCT01426022
Effect of Moderate Alcohol Consumption on Postprandial Mood
A study testing Nutrition and mood manipulation in people with Mood Swings, run by TNO at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Mood Swings
- What is being tested?
- Nutrition and mood manipulation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteNetherlands
- Study dates
- Oct 2011to Dec 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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
- Being tested
- Nutrition, mood manipulation
- Keywords
- alcohol, mood, postprandial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NutritionOther
Also called Alcohol, Ethanol, Wine
Moderate alcohol consumption with dinner (3 glasses of sparkling white wine, containing ca. 30 g alcohol)
mood manipulationBehavioural
Also called Ambience, Ambiance, Positive affect, Emotion
Mood will be manipulated by changing the ambiance in either a pleasant or unpleasant way.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Nutrition |
| Ambiance | Experimental | 1. Pleasant ambiance
2. Unpleasant ambiance Receives: Behavioral: mood manipulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 times during study day, 4 study days (total 20x)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2011 (estimated)
- Study startOct 2011
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Mood SwingsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- TNO
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Henk FJ Hendriks, TNO
- Investigators
- Henk Hendriks, PhD, Principal investigator, TNO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01426022
- Sponsor's protocol ID
- P9334
- Status last verified
- Oct 2012
- First submitted
- 26 Aug 2011
- Last updated
- 18 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 25962070Schrieks 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.
PubMed 24465955
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Moderate Alcohol Consumption With a Meal in Different Ambiances on Postprandial Mood, Evaluated by Subjective and Physiological Responses
- ClinicalTrials.gov ID
- NCT01426022
- Acronym / sponsor ID
- P9334
- Conditions
- Mood Swings
- Keywords
- alcohol, mood, postprandial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- TNOUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 30 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Alcohol | Placebo comparator | Other: Nutrition1. 3 glasses of sparkling white wine (30g alcohol) with dinner 2. 3 glasses of alcohol free sparkling white wine (<2g alcohol) with dinner |
| Ambiance | Experimental | Behavioral: mood manipulation1. Pleasant ambiance 2. Unpleasant ambiance |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NutritionAlso: Alcohol, Ethanol, WineModerate alcohol consumption with dinner (3 glasses of sparkling white wine, containing ca. 30 g alcohol) | Other | Alcohol |
| mood manipulationAlso: Ambience, Ambiance, Positive affect, EmotionMood will be manipulated by changing the ambiance in either a pleasant or unpleasant way. | Behavioural | Ambiance |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2012.
- Derived from this study: PubMed 25962070Schrieks 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.
- Derived from this study: PubMed 24465955Schrieks 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Henk Hendriks, PhD principal investigator
TNO
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutrition and mood manipulation in people with Mood Swings, run by TNO at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Profile of mood states (POMS) (time frame: 5 times during study day, 4 study days (total 20x)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01426022, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2012.