The Effect of Alcohol on Food Reward

This study has been completed.
Sponsor:
Collaborators:
Foundation for Alcohol Research (SAR), The Netherlands
Ministry of Economic Affairs, The Netherlands
Information provided by (Responsible Party):
Henk FJ Hendriks, TNO Quality of Life
ClinicalTrials.gov Identifier:
NCT01738906
First received: November 28, 2012
Last updated: January 2, 2013
Last verified: January 2013
  Purpose

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.

Condition Intervention
Obesity
Body Weight
Other: Orange juice
Other: maltodextrin
Other: Vodka
Other: butter cake MSF
Other: butter cake consumption

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Basic Science
Official Title: The Effect of Moderate Alcohol Consumption on Subsequent Food Reward

Resource links provided by NLM:


Further study details as provided by TNO:

Primary Outcome Measures:
  • Explicit food 'wanting' [ Time Frame: up to 75 minutes ] [ Designated as safety issue: No ]
    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.

  • Implicit food 'wanting' for different food categories [ Time Frame: up to 30 minutes ] [ Designated as safety issue: No ]
    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.

  • explicit food 'wanting' for different food categories [ Time Frame: up to 30 minutes ] [ Designated as safety issue: No ]
    Questionnaire measuring food wanting explicitly for different food categories on a visual analogue scale (ranging 0-100).

  • explicit food 'liking' for different food categories [ Time Frame: up to 30 minutes ] [ Designated as safety issue: No ]
    Questionnaire measuring food 'liking' for different food categories on a visual analogue scale (ranging 0-100).


Enrollment: 24
Study Start Date: October 2012
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Alcohol placebo and MSF
175 mL orange juice with 31 g Fantomalt maltodextrin and modified sham feeding of 40 g butter cake
Other: Orange juice
Other Name: Orange Juice (Appelsientje)
Other: maltodextrin
Other Name: Fantomalt maltodextrin (energy powder), Nutricia
Other: butter cake MSF
chewing on 40 gram cake for 6 minutes and before swallowing expectorating the bolus in cup.
Other Name: cake modified sham feeding
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: Orange juice
Other Name: Orange Juice (Appelsientje)
Other: Vodka
Other Name: Smirnoff Vodka
Other: butter cake MSF
chewing on 40 gram cake for 6 minutes and before swallowing expectorating the bolus in cup.
Other Name: cake modified sham feeding
Experimental: Alcohol placebo and consumption
175 mL orange juice with 31 g maltodextrin and consumption of 40 g butter cake
Other: Orange juice
Other Name: Orange Juice (Appelsientje)
Other: maltodextrin
Other Name: Fantomalt maltodextrin (energy powder), Nutricia
Other: butter cake consumption
chewing for 6 min on 40 gram cake and then swallow it.
Other Name: cake consumption
Experimental: Alcohol and consumption
65 mL vodka with 135 mL orange juice and consumption of 40 g butter cake
Other: Orange juice
Other Name: Orange Juice (Appelsientje)
Other: Vodka
Other Name: Smirnoff Vodka
Other: butter cake consumption
chewing for 6 min on 40 gram cake and then swallow it.
Other Name: cake consumption
Experimental: Alcohol placebo and control
175 mL orange juice with 31 g maltodextrin and no oral exposure to butter cake
Other: Orange juice
Other Name: Orange Juice (Appelsientje)
Other: maltodextrin
Other Name: Fantomalt maltodextrin (energy powder), Nutricia
Experimental: Alcohol and control
65 mL vodka with 135 mL orange juice and no oral exposure to butter cake
Other: Orange juice
Other Name: Orange Juice (Appelsientje)
Other: Vodka
Other Name: Smirnoff Vodka

  Eligibility

Ages Eligible for Study:   25 Years to 50 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01738906

Locations
Netherlands
Centre for Human Drug Research (CHDR)
Leiden, Zuid-Holland, Netherlands, 2333 CL
Sponsors and Collaborators
Henk FJ Hendriks
Foundation for Alcohol Research (SAR), The Netherlands
Ministry of Economic Affairs, The Netherlands
Investigators
Principal Investigator: Henk Hendriks, PhD TNO Zeist, The Netherlands
  More Information

No publications provided

Responsible Party: Henk FJ Hendriks, Project Manager, TNO Quality of Life
ClinicalTrials.gov Identifier: NCT01738906     History of Changes
Other Study ID Numbers: P9532
Study First Received: November 28, 2012
Last Updated: January 2, 2013
Health Authority: Netherlands: Medical Ethics Review Committee (METC)
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Additional relevant MeSH terms:
Body Weight
Obesity
Signs and Symptoms
Overnutrition
Nutrition Disorders
Overweight
Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Central Nervous System Depressants
Physiological Effects of Drugs
Central Nervous System Agents

ClinicalTrials.gov processed this record on July 23, 2014