- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01738906
The Effect of Alcohol on Food Reward
The Effect of Moderate Alcohol Consumption on Subsequent Food Reward
Rationale
It has been shown in several studies that alcohol increases subsequent food intake. However, moderate alcohol consumption has no clear effects on hunger and satiety hormones. In the Western world, where palatable food is highly available, food reward may play an important role in food intake. Alcohol consumption is known to stimulate neurotransmitters important for food reward and may therefore stimulate the reward response on a subsequent meal. This may lead to higher food consumption than when no alcohol is consumed. It is hypothesized that the reward response of food or beverages can already be generated when food or beverages are sensed in the mouth, because oral nutrient sensing is known to induce a satiety response (i.e. the cephalic phase response). Moreover, taste buds directly signal brain areas closely connected to the reward areas in the brain.
Primary objective
- To determine whether moderate alcohol consumption influences subsequent food reward, as measured by questionnaires on food 'wanting' and food 'liking', and salivary and blood parameters related to reward.
Secondary objectives
- To determine whether food reward is different when food is consumed than when food is sensed in the mouth, as measured by questionnaires on food 'wanting' and food 'liking', and salivary and blood parameters related to food reward.
- To determine whether moderate alcohol consumption influences subsequent food reward differently when food is consumed than when food is sensed in the mouth, as measured by questionnaires on food 'wanting' and food 'liking', and salivary and blood parameters related to food reward.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Zuid-Holland
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Leiden, Zuid-Holland, Netherlands, 2333 CL
- Centre for Human Drug Research (CHDR)
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Caucasian men;
- Age 25-50 years on the day of the screening;
- Body Mass Index (BMI) of 20-25 kg/m2;
- Body weight of 60-100 kg;
- Able to read, write and fully understand the Dutch language, and
- Able to participate int he sudy, willing to give written informed consent and to comply with the study procedures and restrictions.
Exclusion Criteria:
- Above average score (>2.26) on the restrained scale of the Dutch Eating Behaviour Questionnaire;
- Alcohol consumption <6 and >20 standard glasses/week;
- Not having regular and normal Dutch eating habits;
- Not having a normal day/night rhythm;
- Smoking, or stopped with smoking <3 months prior to start of the study;
- Using drugs, or stopped using drugs <3 months prior to start of the study;
- Having a (family) history of alcohol or drug related problems;
- Reported slimming or being on a medically described diet;
- Having a vegan, vegetarian or macrobiotic lifestyle;
- Loss of blood outside the limits of Sanquin within 3 months prior to screening;
- Participation in a clinical trial within 3 months prior to the start of this study or more than 4 times a year;
- Having a food allergy, sensitivity or disliking one of the foods used in the study;
- Reported unexplained weight loss or gain of >4 kg in the month prior to the screening;
- Inappropriate veins for cannula insertion;
- Not having a general practitioner or health insurance;
- Having a history of medical or surgical events or disease that may significantly affect the study outcome, particularly physiological disorders, metabolic or endocrine disease and gastrointestinal disorders; and/or
- Any condition which, in the opinion of the investigator, might create undue risk to the subject or interfere with the subject's ability to comply with the protocol.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Alcohol placebo and MSF
175 mL orange juice with 31 g Fantomalt maltodextrin and modified sham feeding of 40 g butter cake
|
Other Names:
Other Names:
chewing on 40 gram cake for 6 minutes and before swallowing expectorating the bolus in cup.
Other Names:
|
Experimental: Alcohol and MSF
65 mL vodka with 135 mL orange juice (ca 20 g alcohol)and modified sham feeding of 40 g butter cake
|
Other Names:
chewing on 40 gram cake for 6 minutes and before swallowing expectorating the bolus in cup.
Other Names:
Other Names:
|
Experimental: Alcohol placebo and consumption
175 mL orange juice with 31 g maltodextrin and consumption of 40 g butter cake
|
Other Names:
Other Names:
chewing for 6 min on 40 gram cake and then swallow it.
Other Names:
|
Experimental: Alcohol and consumption
65 mL vodka with 135 mL orange juice and consumption of 40 g butter cake
|
Other Names:
Other Names:
chewing for 6 min on 40 gram cake and then swallow it.
Other Names:
|
Experimental: Alcohol placebo and control
175 mL orange juice with 31 g maltodextrin and no oral exposure to butter cake
|
Other Names:
Other Names:
|
Experimental: Alcohol and control
65 mL vodka with 135 mL orange juice and no oral exposure to butter cake
|
Other Names:
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Explicit food 'wanting'
Time Frame: up to 75 minutes
|
Questionnaire measuring food 'wanting' explicitly with the question: "How much do you want to eat at this moment?"
This is scored on a visual analogue scale ranging from 0-100.
|
up to 75 minutes
|
Implicit food 'wanting' for different food categories
Time Frame: up to 30 minutes
|
Computer task measuring food 'wanting' implicitly for different food categories.
This is a forced choice task in which subjects have to choose as quick and precise the food product they want to eat most at that moment.
|
up to 30 minutes
|
explicit food 'wanting' for different food categories
Time Frame: up to 30 minutes
|
Questionnaire measuring food wanting explicitly for different food categories on a visual analogue scale (ranging 0-100).
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up to 30 minutes
|
explicit food 'liking' for different food categories
Time Frame: up to 30 minutes
|
Questionnaire measuring food 'liking' for different food categories on a visual analogue scale (ranging 0-100).
|
up to 30 minutes
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Henk Hendriks, PhD, TNO Zeist, The Netherlands
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P9532
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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