- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01544816
Evaluating the Effects of Snack Products on Energy
2013년 5월 6일 업데이트: Mondelēz International, Inc.
To determine the effect of snack products varying in composition, on energy in healthy adult subjects.
연구 개요
연구 유형
중재적
등록 (실제)
49
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Georgia
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Atlanta, Georgia, 미국, 30341
- Mercer University Center for Clinical Research
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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
20년 (성인)
건강한 자원 봉사자를 받아들입니다
예
연구 대상 성별
모두
설명
Inclusion Criteria:
- The subject must provide informed consent.
- The subject is male or female, and between the ages of 20 and 45, inclusive.
- The subject is a routine, moderate daily user of caffeine (approximately 1-4 cups of coffee or equivalent).
- The subject is fluent in English.
- The subject has a minimum of a high school diploma.
- Females of Child-bearing Potential (FOCP) must have a negative urine or serum beta HCG pregnancy test at screening. FOCP must abstain from sexual activity that could result in a pregnancy, or use acceptable contraceptives throughout the period of study treatment exposure. Acceptable contraceptives include IUDs, hormonal contraceptives (oral, implanted or injectable) and double barrier methods (such as condom or diaphragm with spermicidal gel). If hormonal contraceptives are used, the period of use must be sufficiently long to achieve pharmacological effectiveness prior to study treatment exposure (refer to individual product information for details on onset of effectiveness). FOCP who are not currently sexually active, must agree to use acceptable contraception, as defined above, if they decide to become sexually active during the period of study treatment exposure .
- The subject is in good physical and mental health based on a general medical history.
- The subject has adequate visual and auditory acuity and cognitive ability to complete the assessments and is capable of understanding and following instructions for the performance tests within the normal, age-adjusted range (within one SD) at screening.
- Must be able and willing to obtain a minimum of 7 hours of sleep the night prior to each study visit.
- The subject is willing and able to comply with all requirements defined within this protocol.
- The subject reports having a snack at least two afternoons per week.
- The subject reports experiencing an "afternoon slump".
Exclusion Criteria
- The subject has a current Axis I or Axis II comorbid psychiatric diagnosis or other symptomatic manifestations that, in the opinion of the examining physician (Investigator), will contraindicate treatment with caffeine.
- Attention Deficit Disorder or Attention Deficit Hyperactivity Disorder
- BMI ≤ 19 or ≥ 30 kg/m2.
- The subject has documented allergies, adverse reactions, or intolerance to caffeine.
- The subject has any significant medical illness or condition for which caffeine is contraindicated.
- The subject has a history of drug dependence or substance use disorder based upon DSM-IV-TR criteria (excluding nicotine).
- The subject has a positive urine drug or alcohol drug test result (to include nicotine).
- The subject has participated in an investigational study or received an investigational drug within the past 28 days.
- The subject has used nicotine products within 30 days of screening or during the duration of the study.
- The subject is taking medications, that have CNS effects or affect performance, (such as sedating antihistamines and decongestant sympathomimetics, either oral or topical), and may interfere with efficacy or safety assessments.
- The subject has a concurrent chronic or acute illness (such as allergic rhinitis or severe cold), disability, or other condition that might confound the results of rating tests administered in the study or that might increase risk to the subject. Similarly, the subject will be excluded if he or she has any additional conditions that, in the Investigator's opinion, would preclude the subject from completing the study or would not be in the best interest of the subject. This would include any significant illness or unstable medical condition that could lead to difficulty complying with the protocol.
- The female subject is pregnant or lactating or planning on becoming pregnant during the study
- Hypertension or other chronic medical conditions
- Individuals who do not maintain a routine nighttime sleep schedule (e.g. no shift work).
- Individuals judged by the Investigator to be unsuitable for enrollment in this study for any reason.
- The subject has been diagnosed with phenylketonuria.
- Inability to perform performance tests within the Normal range (i.e., performance no lower than 1SD below the mean) at screening.
- The subject has a pre-existing medical condition.
- Subject has been diagnosed with a sleeping disorder.
- Subject has a fasting glucose of >110 mg/dl.
- Subject has an allergy to wheat, soy, nuts or other food.
- Subject has Kosher or Halal dietary restrictions.
- Subject reports never eating biscuits, cookies or crackers.
- Epworth Sleepiness Scale ≥ at screening (i.e., evidence of excessive daytime sleepiness).
- Dislike of chocolate flavorings
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 기초 과학
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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위약 비교기: Control Food Product
Control food product
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control food product
Experimental food product containing ingredient 1
Experimental food product containing ingredient 2
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실험적: Experimental Food Product 1
Experimental food product 1
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control food product
Experimental food product containing ingredient 1
Experimental food product containing ingredient 2
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실험적: Experimental Food Product 2
Experimental food product 2
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control food product
Experimental food product containing ingredient 1
Experimental food product containing ingredient 2
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
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Energy questionnaire OR Rating of perceived energy OR Subjective feeling of energy (visual analog scale)
기간: 90 minutes post snack
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90 minutes post snack
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Chad VanDenBerg, Pharm.D., Mercer University
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
2012년 2월 1일
기본 완료 (실제)
2012년 8월 1일
연구 완료 (실제)
2012년 8월 1일
연구 등록 날짜
최초 제출
2012년 2월 24일
QC 기준을 충족하는 최초 제출
2012년 2월 29일
처음 게시됨 (추정)
2012년 3월 6일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
2013년 5월 8일
QC 기준을 충족하는 마지막 업데이트 제출
2013년 5월 6일
마지막으로 확인됨
2013년 5월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- KFG-123X-01
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. .
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