The Effect of Alcohol on Food Reward

NCT ID: NCT01738906

Last Updated: 2013-01-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-10-31
• Study Completion Date: 2012-12-31

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.

Conditions

Obesity; Body Weight

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

Alcohol placebo and MSF

175 mL orange juice with 31 g Fantomalt maltodextrin and modified sham feeding of 40 g butter cake

Group Type: EXPERIMENTAL

Orange juice

Intervention Type: OTHER

maltodextrin

Intervention Type: OTHER

butter cake MSF

Intervention Type: OTHER

chewing on 40 gram cake for 6 minutes and before swallowing expectorating the bolus in cup.

Alcohol and MSF

65 mL vodka with 135 mL orange juice (ca 20 g alcohol)and modified sham feeding of 40 g butter cake

Group Type: EXPERIMENTAL

Orange juice

Intervention Type: OTHER

Vodka

Intervention Type: OTHER

butter cake MSF

Intervention Type: OTHER

chewing on 40 gram cake for 6 minutes and before swallowing expectorating the bolus in cup.

Alcohol placebo and consumption

175 mL orange juice with 31 g maltodextrin and consumption of 40 g butter cake

Group Type: EXPERIMENTAL

Orange juice

Intervention Type: OTHER

maltodextrin

Intervention Type: OTHER

butter cake consumption

Intervention Type: OTHER

chewing for 6 min on 40 gram cake and then swallow it.

Alcohol and consumption

65 mL vodka with 135 mL orange juice and consumption of 40 g butter cake

Group Type: EXPERIMENTAL

Orange juice

Intervention Type: OTHER

Vodka

Intervention Type: OTHER

butter cake consumption

Intervention Type: OTHER

chewing for 6 min on 40 gram cake and then swallow it.

Alcohol placebo and control

175 mL orange juice with 31 g maltodextrin and no oral exposure to butter cake

Group Type: EXPERIMENTAL

Orange juice

Intervention Type: OTHER

maltodextrin

Intervention Type: OTHER

Alcohol and control

65 mL vodka with 135 mL orange juice and no oral exposure to butter cake

Group Type: EXPERIMENTAL

Orange juice

Intervention Type: OTHER

Vodka

Intervention Type: OTHER

Interventions

Orange juice

Intervention Type: OTHER

maltodextrin

Intervention Type: OTHER

Vodka

Intervention Type: OTHER

butter cake MSF

chewing on 40 gram cake for 6 minutes and before swallowing expectorating the bolus in cup.

Intervention Type: OTHER

butter cake consumption

chewing for 6 min on 40 gram cake and then swallow it.

Intervention Type: OTHER

Other Intervention Names

Orange Juice (Appelsientje); Fantomalt maltodextrin (energy powder), Nutricia; Smirnoff Vodka; cake modified sham feeding; cake consumption

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.

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Foundation for Alcohol Research (SAR), The Netherlands

UNKNOWN

Sponsor Role: collaborator

Ministry of Economic Affairs, The Netherlands

UNKNOWN

Sponsor Role: collaborator

Henk FJ Hendriks

OTHER

Sponsor Role: lead

Responsible Party

Henk FJ Hendriks

Project Manager

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Henk Hendriks, PhD

Role: PRINCIPAL_INVESTIGATOR

TNO Zeist, The Netherlands

Locations

Centre for Human Drug Research (CHDR)

Leiden, South Holland, Netherlands

Countries

Netherlands

Other Identifiers

P9532

Identifier Type: -

Identifier Source: org_study_id