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
| November 28, 2012 |
| January 2, 2013 |
| October 2012 |
| December 2012 (final data collection date for primary outcome measure) |
- 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).
|
| Same as current |
| Complete list of historical versions of study NCT01738906 on ClinicalTrials.gov Archive Site |
| Not Provided |
| Not Provided |
| Not Provided |
| Not Provided |
| |
| The Effect of Alcohol on Food Reward |
| The Effect of Moderate Alcohol Consumption on Subsequent Food Reward |
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.
|
| Not Provided |
| Interventional |
| Not Provided |
Allocation: Randomized Endpoint Classification: Pharmacodynamics Study Intervention Model: Crossover Assignment Masking: Single Blind (Subject) Primary Purpose: Basic Science |
|
|
- Other: Orange juice
Other Name: Orange Juice (Appelsientje)
- Other: maltodextrin
Other Name: Fantomalt maltodextrin (energy powder), Nutricia
- 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
- Other: butter cake consumption
chewing for 6 min on 40 gram cake and then swallow it.
Other Name: cake consumption
|
- Experimental: Alcohol placebo and MSF
175 mL orange juice with 31 g Fantomalt maltodextrin and modified sham feeding of 40 g butter cake
Interventions:
- Other: Orange juice
- Other: maltodextrin
- Other: butter cake MSF
- 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
Interventions:
- Other: Orange juice
- Other: Vodka
- Other: butter cake MSF
- Experimental: Alcohol placebo and consumption
175 mL orange juice with 31 g maltodextrin and consumption of 40 g butter cake
Interventions:
- Other: Orange juice
- Other: maltodextrin
- Other: butter cake consumption
- Experimental: Alcohol and consumption
65 mL vodka with 135 mL orange juice and consumption of 40 g butter cake
Interventions:
- Other: Orange juice
- Other: Vodka
- Other: butter cake consumption
- Experimental: Alcohol placebo and control
175 mL orange juice with 31 g maltodextrin and no oral exposure to butter cake
Interventions:
- Other: Orange juice
- Other: maltodextrin
- Experimental: Alcohol and control
65 mL vodka with 135 mL orange juice and no oral exposure to butter cake
Interventions:
- Other: Orange juice
- Other: Vodka
|
| Not Provided |
| |
| Completed |
| 24 |
| December 2012 |
| December 2012 (final data collection date for primary outcome measure) |
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.
|
| Male |
| 25 Years to 50 Years |
| Yes |
| Contact information is only displayed when the study is recruiting subjects |
| Netherlands |
| |
| NCT01738906 |
| P9532 |
| No |
| Henk FJ Hendriks, TNO Quality of Life |
| Henk FJ Hendriks |
- Foundation for Alcohol Research (SAR), The Netherlands
- Ministry of Economic Affairs, The Netherlands
|
| Principal Investigator: |
Henk Hendriks, PhD |
TNO Zeist, The Netherlands |
|
|
| TNO Quality of Life |
| January 2013 |