Clinical trial NCT01738906: The Effect of Alcohol on Food Reward
Official title: The Effect of Moderate Alcohol Consumption on Subsequent Food Reward
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Body Weight
Lead sponsor: TNO
Sponsor class: OTHER
Collaborators: name: Foundation for Alcohol Research (SAR), The Netherlands
name: Ministry of Economic Affairs, The Netherlands
First posted: 2012-11-30
Enrollment: 24
Sex: MALE
Minimum age (years): 25
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Explicit food 'wanting'
timeFrame: up to 75 minutes
measure: Implicit food 'wanting' for different food categories
timeFrame: up to 30 minutes
measure: explicit food 'wanting' for different food categories
timeFrame: up to 30 minutes
measure: explicit food 'liking' for different food categories
timeFrame: up to 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Leiden
country: Netherlands
facility: Centre for Human Drug Research (CHDR)
state: Zuid-Holland
Study officials:
affiliation: TNO Zeist, The Netherlands
name: Henk Hendriks, PhD
role: PRINCIPAL_INVESTIGATOR
References: