NCT01738906

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Oct 2012

Shorter than P25 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 28, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 30, 2012

Completed
1 day until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

January 3, 2013

Status Verified

January 1, 2013

Enrollment Period

2 months

First QC Date

November 28, 2012

Last Update Submit

January 2, 2013

Conditions

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

  • 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

  • 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

Study Arms (6)

Alcohol placebo and MSF

EXPERIMENTAL

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

Other: Orange juiceOther: maltodextrinOther: butter cake MSF

Alcohol and MSF

EXPERIMENTAL

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

Other: Orange juiceOther: VodkaOther: butter cake MSF

Alcohol placebo and consumption

EXPERIMENTAL

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

Other: Orange juiceOther: maltodextrinOther: butter cake consumption

Alcohol and consumption

EXPERIMENTAL

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

Other: Orange juiceOther: VodkaOther: butter cake consumption

Alcohol placebo and control

EXPERIMENTAL

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

Other: Orange juiceOther: maltodextrin

Alcohol and control

EXPERIMENTAL

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

Other: Orange juiceOther: Vodka

Interventions

Also known as: Orange Juice (Appelsientje)
Alcohol and MSFAlcohol and consumptionAlcohol and controlAlcohol placebo and MSFAlcohol placebo and consumptionAlcohol placebo and control
Also known as: Fantomalt maltodextrin (energy powder), Nutricia
Alcohol placebo and MSFAlcohol placebo and consumptionAlcohol placebo and control
VodkaOTHER
Also known as: Smirnoff Vodka
Alcohol and MSFAlcohol and consumptionAlcohol and control

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

Also known as: cake modified sham feeding
Alcohol and MSFAlcohol placebo and MSF

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

Also known as: cake consumption
Alcohol and consumptionAlcohol placebo and consumption

Eligibility Criteria

Age25 Years - 50 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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;
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre for Human Drug Research (CHDR)

Leiden, South Holland, 2333 CL, Netherlands

Location

MeSH Terms

Conditions

ObesityBody Weight

Interventions

maltodextrin

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Henk Hendriks, PhD

    TNO Zeist, The Netherlands

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Project Manager

Study Record Dates

First Submitted

November 28, 2012

First Posted

November 30, 2012

Study Start

October 1, 2012

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

January 3, 2013

Record last verified: 2013-01

Locations