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The Effect of Alcohol on Food Reward

Primary Purpose

Obesity, Body Weight

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Orange juice
maltodextrin
Vodka
butter cake MSF
butter cake consumption
Sponsored by
Henk FJ Hendriks
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Obesity

Eligibility Criteria

25 Years - 50 Years (Adult)MaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Centre for Human Drug Research (CHDR)

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Alcohol placebo and MSF

Alcohol and MSF

Alcohol placebo and consumption

Alcohol and consumption

Alcohol placebo and control

Alcohol and control

Arm Description

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

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

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

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

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

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

Outcomes

Primary Outcome Measures

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.
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.
explicit food 'wanting' for different food categories
Questionnaire measuring food wanting explicitly for different food categories on a visual analogue scale (ranging 0-100).
explicit food 'liking' for different food categories
Questionnaire measuring food 'liking' for different food categories on a visual analogue scale (ranging 0-100).

Secondary Outcome Measures

Full Information

First Posted
November 28, 2012
Last Updated
January 2, 2013
Sponsor
Henk FJ Hendriks
Collaborators
Foundation for Alcohol Research (SAR), The Netherlands, Ministry of Economic Affairs, The Netherlands
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1. Study Identification

Unique Protocol Identification Number
NCT01738906
Brief Title
The Effect of Alcohol on Food Reward
Official Title
The Effect of Moderate Alcohol Consumption on Subsequent Food Reward
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Henk FJ Hendriks
Collaborators
Foundation for Alcohol Research (SAR), The Netherlands, Ministry of Economic Affairs, The Netherlands

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Body Weight

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Alcohol placebo and MSF
Arm Type
Experimental
Arm Description
175 mL orange juice with 31 g Fantomalt maltodextrin and modified sham feeding of 40 g butter cake
Arm Title
Alcohol and MSF
Arm Type
Experimental
Arm Description
65 mL vodka with 135 mL orange juice (ca 20 g alcohol)and modified sham feeding of 40 g butter cake
Arm Title
Alcohol placebo and consumption
Arm Type
Experimental
Arm Description
175 mL orange juice with 31 g maltodextrin and consumption of 40 g butter cake
Arm Title
Alcohol and consumption
Arm Type
Experimental
Arm Description
65 mL vodka with 135 mL orange juice and consumption of 40 g butter cake
Arm Title
Alcohol placebo and control
Arm Type
Experimental
Arm Description
175 mL orange juice with 31 g maltodextrin and no oral exposure to butter cake
Arm Title
Alcohol and control
Arm Type
Experimental
Arm Description
65 mL vodka with 135 mL orange juice and no oral exposure to butter cake
Intervention Type
Other
Intervention Name(s)
Orange juice
Other Intervention Name(s)
Orange Juice (Appelsientje)
Intervention Type
Other
Intervention Name(s)
maltodextrin
Other Intervention Name(s)
Fantomalt maltodextrin (energy powder), Nutricia
Intervention Type
Other
Intervention Name(s)
Vodka
Other Intervention Name(s)
Smirnoff Vodka
Intervention Type
Other
Intervention Name(s)
butter cake MSF
Other Intervention Name(s)
cake modified sham feeding
Intervention Description
chewing on 40 gram cake for 6 minutes and before swallowing expectorating the bolus in cup.
Intervention Type
Other
Intervention Name(s)
butter cake consumption
Other Intervention Name(s)
cake consumption
Intervention Description
chewing for 6 min on 40 gram cake and then swallow it.
Primary Outcome Measure Information:
Title
Explicit food 'wanting'
Description
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.
Time Frame
up to 75 minutes
Title
Implicit food 'wanting' for different food categories
Description
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.
Time Frame
up to 30 minutes
Title
explicit food 'wanting' for different food categories
Description
Questionnaire measuring food wanting explicitly for different food categories on a visual analogue scale (ranging 0-100).
Time Frame
up to 30 minutes
Title
explicit food 'liking' for different food categories
Description
Questionnaire measuring food 'liking' for different food categories on a visual analogue scale (ranging 0-100).
Time Frame
up to 30 minutes

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Henk Hendriks, PhD
Organizational Affiliation
TNO Zeist, The Netherlands
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre for Human Drug Research (CHDR)
City
Leiden
State/Province
Zuid-Holland
ZIP/Postal Code
2333 CL
Country
Netherlands

12. IPD Sharing Statement

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The Effect of Alcohol on Food Reward

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