The Effect of Alcohol on Food Reward

Obesity Clinical Trial

Official title:

The Effect of Moderate Alcohol Consumption on Subsequent Food Reward

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01738906
• Other study ID #: P9532
• Status: Completed
• Phase: N/A
• First received: November 28, 2012
• Last updated: January 2, 2013
• Start date: October 2012
• Est. completion date: December 2012

Study information

• Verified date: January 2013
• Source: TNO
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 25 Years to 50 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Body Weight
• Obesity

Intervention

Other:
• Orange juice

• maltodextrin

• Vodka

• butter cake MSF
chewing on 40 gram cake for 6 minutes and before swallowing expectorating the bolus in cup.
• butter cake consumption
chewing for 6 min on 40 gram cake and then swallow it.

Locations

Country	Name	City	State
Netherlands	Centre for Human Drug Research (CHDR)	Leiden	Zuid-Holland

Sponsors (3)

Lead Sponsor	Collaborator
Henk FJ Hendriks	Foundation for Alcohol Research (SAR), The Netherlands, Ministry of Economic Affairs, The Netherlands

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Explicit food 'wanting'	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	No
Primary	Implicit food 'wanting' for different food categories	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	No
Primary	explicit food 'wanting' for different food categories	Questionnaire measuring food wanting explicitly for different food categories on a visual analogue scale (ranging 0-100).	up to 30 minutes	No
Primary	explicit food 'liking' for different food categories	Questionnaire measuring food 'liking' for different food categories on a visual analogue scale (ranging 0-100).	up to 30 minutes	No