이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

Pleasure for Food and Endocannabinoids in Obesity (PLOBEC)

A New Method for the Characterisation of Pleasure for Food in Obesity and Relationships With the Endocannabinoid System

Disturbances in hedonic and motivational processes play a major role in the pathophysiology of obesity. To date, experimental approaches for the study of emotional and motivational processing rely on subjective assessment scales. We have therefore developed two novel computer-generated tasks challenging respectively visual and temporal discrimination capacities for a quantitative and objective measurement of the hedonic and motivational state in humans. According to the task, the subjects are asked to view and to compare two stimuli, an appetitive one (food pictures) and its devalued counterpart (food pictures in greyscale), at each trial, assessing either the size (task A) or the duration of presentation (task B). From these considerations, the present project aims at using our novel tool to: i) assess the hedonic and motivational state in subjects with obesity, ii) compare their responses with healthy volunteers, and iii) establish relationships with biological markers known to be highly involved in the regulation of both emotional and motivational processes, such as endocannabinoids. The present project should demonstrate that the behavioral tests validated in our laboratory are relevant experimental tools for the diagnostic/clinical assessment and for the phenotypic characterization of obese patients. The application of the test in the therapeutic context could add further information about the efficacy and relevance of the chosen therapy. Finally, our project will provide information on the biological substrates of hedonic and motivational impairments that might become target of therapy in obesity.

연구 개요

상태

알려지지 않은

정황

상세 설명

Disturbances in hedonic and motivational processes play a major role in the pathophysiology of reward-related diseases, such as obesity. To date, experimental approaches for the study of emotional and motivational processing rely on subjective assessment scales. We have therefore developed and validated a novel computer-generated test challenging visual and temporal discrimination capacities in humans. The subjects are asked to view and to compare two stimuli, an appetitive one (food pictures; F) and its devalued counterpart (food pictures in greyscale; D), at each trial, assessing either the size (task A) or the duration of presentation (task B). Geometric figures are used as controls and presented in color (C) or greyscale (D). Both tasks are registered under the French agency for the protection of computer software. Here, we propose to use our novel test to: i) assess the hedonic and motivational state in subjects suffering from obesity, ii) compare their responses with healthy volunteers, and iii) establish relationships with biological markers known to be highly involved in the regulation of both emotional and motivational processes, such as endocannabinoids. Responses to the test in obese patients will be evaluated during two separate experimental sessions under either fasting or satiety conditions.

The present study is expected to begin mid-November 2013 for a total duration of 24 consecutive months. A sample of 25 patients suffering from obesity will be recruited and compared with 25 healthy normal volunteers who are free from any previous or current metabolic and psychiatric disorders. They will be matched on age and sex. They will be screened using the "Association pour la Méthodologie et la Documentation en Psychiatrie" questionnaire for obtaining a series of information, comprising the marital status, number of children, number of siblings, education and training, professional qualifications, significant life events… They will be evaluated with the Mini-International Neuropsychiatric Interview in order to determine the presence of mood disorders and associated psychopathology. The Three-Factor Eating Questionnaire will be employed for measuring three separate aspects of eating behavior: cognitive restraint, uncontrolled eating, and emotional eating. This will be completed with the Multidimensional Body Self-Relations Questionnaire and the State-Trait Anxiety Inventory in order to assess the body satisfaction and anxiety levels, respectively. Beyond all these assessments, two separate experimental sessions will be conducted, one in satiety and the other in fasting. During each session, the participants will be asked to perform the two validated instrumental tasks in front the screen of a computer. Plasma levels of endocannabinoids will be monitered by collecting blood samples prior to the consumption of a calorically-defined meal and while carrying out the computer-generated tasks under satiety. Blood will be withdrawn at the same time-points during the session in fasting. Visual analogue scales (VAS) assessing hunger levels will be completed before blood is collected. A VAS will be also used for the global assessment of appetitive properties of the viewed food images just before the end of the second experimental session.

연구 유형

중재적

등록 (예상)

50

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

      • Bordeaux, 프랑스, 33077
        • 모병
        • Neurocentre Magendie (INSERM U862)
        • 연락하다:
        • 수석 연구원:
          • Bruno Aouizerate, Professor
        • 부수사관:
          • Antoine Tabarin, Professor
        • 부수사관:
          • Blandine Gatta-Cherifi, Professor
        • 부수사관:
          • Camille Gouzien, Doctor

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 (성인)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

Inclusion Criteria:

Obese patients :

  1. Be between 18 and 60 year-old
  2. Have a body mass index ranging from 35 to 50 kg/m2
  3. Have no previous history of surgical treatment of obesity
  4. Have received no standard intervention for obesity within the last 3 months before study
  5. Have a stable weight (variation <5%) within the last 3 months before study
  6. Have a restriction score <9 on the three-factor eating questionnaire
  7. Be free from any current and previous psychiatric disorder, such as major depression or drug abuse/dependence
  8. Understand and accept the design and constraints of the present study
  9. Be a beneficiary or member of health insurance plan
  10. Provide written consent to the study after receiving clear information

Healthy volunteers :

  1. Be between 18 and 60 year-old
  2. Be free from any current and previous psychiatric disorder, such as major depression or drug abuse/dependence
  3. Understand and accept the design and constraints of the present study
  4. Be a beneficiary or member of health insurance plan
  5. Provide written consent to the study after receiving clear information

Exclusion Criteria:

Obese patients :

  1. Suffer from monogenic obesity
  2. Take any psychotropic treatment such as anxiolytic/hypnotic drugs over the last week preceding the study
  3. Be a pregnant or nursing woman
  4. Use alcohol over the last two days preceding the study

Healthy volunteers :

  1. Suffer from any current and previous somatic or psychiatric condition
  2. Have a body mass index below 18,5 kg/m2 or above 25 kg/m2
  3. Take any psychotropic treatment such as anxiolytic/hypnotic drugs over the last week preceding the study
  4. Be a pregnant or nursing woman
  5. Use alcohol over the last two days preceding the study

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 상영
  • 할당: 무작위화되지 않음
  • 중재 모델: 병렬 할당
  • 마스킹: 하나의

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Obese patients
Computer-based tasks evaluating size and time discrimination capacities Blood sampling for the determination of plasma endocannabinoids levels
Computer-based tasks designed to assess size and time discrimination capacities
Blood drawn for the measurement of circulating endocannabinoids concentrations
실험적: Normal-weight healthy volunteers
Computer-based tasks evaluating size and time discrimination capacities Blood sampling for the determination of plasma endocannabinoids levels
Computer-based tasks designed to assess size and time discrimination capacities
Blood drawn for the measurement of circulating endocannabinoids concentrations

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Change in the Point of subjective equality (PSE)
기간: From fasting to satiety conditions 3 days apart (days 4 and 7 after inclusion)
The PSE is defined as the ratio "F"/"D" or "C"/"D" for which the stimulus "F" or "C" was judged greater than "D" with a probability of 0.5
From fasting to satiety conditions 3 days apart (days 4 and 7 after inclusion)

2차 결과 측정

결과 측정
측정값 설명
기간
Change in the Percentage of subjective discrimination (PSD)
기간: From fasting to satiety conditions 3 days apart (days 4 and 7 after inclusion)
The PSD is defined as the percentage of responses where the stimulus "F" or "C" was judged greater than "D" during the trials where the stimulus "F" or "C" was physically equal to "D", in terms of size or duration of presentation.
From fasting to satiety conditions 3 days apart (days 4 and 7 after inclusion)
Circulating endocannabinoids concentrations
기간: Determined on blood samples collected during the experimental sessions under fasting and satiety (days 4 and 7 after inclusion)
Determined on blood samples collected during the experimental sessions under fasting and satiety (days 4 and 7 after inclusion)

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

수사관

  • 수석 연구원: Bruno Aouizerate, Professor, Neurocentre Magendie (INSERM U862)

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작

2014년 1월 1일

기본 완료 (예상)

2016년 2월 1일

연구 완료 (예상)

2016년 2월 1일

연구 등록 날짜

최초 제출

2013년 11월 4일

QC 기준을 충족하는 최초 제출

2013년 11월 8일

처음 게시됨 (추정)

2013년 11월 15일

연구 기록 업데이트

마지막 업데이트 게시됨 (추정)

2016년 2월 24일

QC 기준을 충족하는 마지막 업데이트 제출

2016년 2월 23일

마지막으로 확인됨

2016년 2월 1일

추가 정보

이 연구와 관련된 용어

기타 연구 ID 번호

  • C13-33
  • 2013-A00982-43 (레지스트리 식별자: IDRCB)

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

미국에서 제조되어 미국에서 수출되는 제품

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

Computer-based tasks에 대한 임상 시험

3
구독하다