ObesityNCT01738906
The Effect of Alcohol on Food Reward
A study testing Orange juice, maltodextrin and Vodka in people with Obesity and Body Weight, run by Henk FJ Hendriks at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity, Body Weight
- What is being tested?
- Orange juice, maltodextrin and Vodka
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteNetherlands
- Study dates
- Oct 2012to Dec 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 17Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Centre for Human Drug Research (CHDR)
Leiden, South Holland, 2333 CL
About this study
Official title: 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.
Read more
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
- Being tested
- Orange juice, maltodextrin, Vodka, butter cake MSF, butter cake consumption
- Medical subject headings
- Obesity, Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Orange juiceOther
Also called Orange Juice (Appelsientje)
maltodextrinOther
Also called Fantomalt maltodextrin (energy powder), Nutricia
VodkaOther
Also called Smirnoff Vodka
butter cake MSFOther
Also called cake modified sham feeding
chewing on 40 gram cake for 6 minutes and before swallowing expectorating the bolus in cup.
butter cake consumptionOther
Also called cake consumption
chewing for 6 min on 40 gram cake and then swallow it.
| Study group | Role | What they receive |
|---|---|---|
| Alcohol placebo and MSF | Experimental | 175 mL orange juice with 31 g Fantomalt maltodextrin and modified sham feeding of 40 g butter cake Receives: Other: Orange juice; Other: maltodextrin; Other: 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 Receives: Other: Orange juice; Other: Vodka; Other: butter cake MSF |
| Alcohol placebo and consumption | Experimental | 175 mL orange juice with 31 g maltodextrin and consumption of 40 g butter cake Receives: Other: Orange juice; Other: maltodextrin; Other: butter cake consumption |
| Alcohol and consumption | Experimental | 65 mL vodka with 135 mL orange juice and consumption of 40 g butter cake Receives: Other: Orange juice; Other: Vodka; Other: butter cake consumption |
| Alcohol placebo and control | Experimental | 175 mL orange juice with 31 g maltodextrin and no oral exposure to butter cake Receives: Other: Orange juice; Other: maltodextrin |
| Alcohol and control | Experimental | 65 mL vodka with 135 mL orange juice and no oral exposure to butter cake Receives: Other: Orange juice; Other: Vodka |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: up to 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2012 (estimated)
- Study startOct 2012
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henk FJ Hendriks
- Sponsor type
- University, hospital or other
- Collaborators
- Foundation for Alcohol Research (SAR), The Netherlands, Ministry of Economic Affairs, The Netherlands
- Responsible party
- Sponsor-investigator, Henk FJ Hendriks, TNO
- Investigators
- Henk Hendriks, PhD, Principal investigator, TNO Zeist, The Netherlands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01738906
- Sponsor's protocol ID
- P9532
- Status last verified
- Jan 2013
- First submitted
- 28 Nov 2012
- Last updated
- 3 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Moderate Alcohol Consumption on Subsequent Food Reward
- ClinicalTrials.gov ID
- NCT01738906
- Acronym / sponsor ID
- P9532
- Conditions
- Obesity, Body Weight
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Henk FJ HendriksUniversity, hospital or other
- Collaborators
- Foundation for Alcohol Research (SAR), The Netherlands, Ministry of Economic Affairs, The Netherlands
- Study start
- Oct 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 30 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Alcohol placebo and MSF | Experimental | Other: Orange juice, Other: maltodextrin, Other: butter cake MSF175 mL orange juice with 31 g Fantomalt maltodextrin and modified sham feeding of 40 g butter cake |
| Alcohol and MSF | Experimental | Other: Orange juice, Other: Vodka, Other: butter cake MSF65 mL vodka with 135 mL orange juice (ca 20 g alcohol)and modified sham feeding of 40 g butter cake |
| Alcohol placebo and consumption | Experimental | Other: Orange juice, Other: maltodextrin, Other: butter cake consumption175 mL orange juice with 31 g maltodextrin and consumption of 40 g butter cake |
| Alcohol and consumption | Experimental | Other: Orange juice, Other: Vodka, Other: butter cake consumption65 mL vodka with 135 mL orange juice and consumption of 40 g butter cake |
| Alcohol placebo and control | Experimental | Other: Orange juice, Other: maltodextrin175 mL orange juice with 31 g maltodextrin and no oral exposure to butter cake |
| Alcohol and control | Experimental | Other: Orange juice, Other: Vodka65 mL vodka with 135 mL orange juice and no oral exposure to butter cake |
Who may qualify
- Ages
- 25 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (17 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Orange juiceAlso: Orange Juice (Appelsientje) | Other | Alcohol and MSF, Alcohol and consumption, Alcohol and control, Alcohol placebo and MSF, Alcohol placebo and consumption, Alcohol placebo and control |
| maltodextrinAlso: Fantomalt maltodextrin (energy powder), Nutricia | Other | Alcohol placebo and MSF, Alcohol placebo and consumption, Alcohol placebo and control |
| VodkaAlso: Smirnoff Vodka | Other | Alcohol and MSF, Alcohol and consumption, Alcohol and control |
| butter cake MSFAlso: cake modified sham feedingchewing on 40 gram cake for 6 minutes and before swallowing expectorating the bolus in cup. | Other | Alcohol and MSF, Alcohol placebo and MSF |
| butter cake consumptionAlso: cake consumptionchewing for 6 min on 40 gram cake and then swallow it. | Other | Alcohol and consumption, Alcohol placebo and consumption |
Primary outcome
Explicit food 'wanting'
Time frame: up to 75 minutes
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
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
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
Questionnaire measuring food 'liking' for different food categories on a visual analogue scale (ranging 0-100).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Henk Hendriks, PhD principal investigator
TNO Zeist, The Netherlands
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Orange juice, maltodextrin and Vodka in people with Obesity and Body Weight, run by Henk FJ Hendriks at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Explicit food 'wanting' (time frame: up to 75 minutes). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2013.