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临床试验/NCT01738906
NCT01738906已完成不适用

The Effect of Moderate Alcohol Consumption on Subsequent Food Reward

Henk FJ Hendriks2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2012年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
24
试验地点
2
主要终点
Explicit food 'wanting'

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
Single (Participant)

入排标准

年龄范围
25 Years 至 50 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

Explicit food 'wanting'

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: up to 30 minutes

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

次要结局

未报告次要终点

研究者

发起方
Henk FJ Hendriks
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Henk FJ Hendriks

Project Manager

TNO

研究点 (2)

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