- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01143194
A Randomized, Placebo-Controlled, Double-Blind, Crossover Study to Evaluate the Effects of Three Doses of the Dietary Supplement oréVida™ on Alertness, Attention and Concentration in Healthy Men and Women
The purpose of this study is to investigate the effects of the dietary supplement oréVida™ (active ingredient on the basis of a culinary herb)administered twice daily in an acute study on an improvement in vigilance, attention, concentration, memory and mood in 45 healthy men and pre-menopausal women, aged 35-50 years, inclusive.
oréVida™ is considered a dietary supplement, and therefore it is not an approved drug by the Food and Drug Administration (FDA). It is regulated like a food. The U.S. Food and Drug Administration does not strictly regulate herbs and dietary supplements. We do not claim that this supplement is meant to treat any ailment.
연구 개요
상태
연구 유형
등록 (실제)
단계
- 1단계
연락처 및 위치
연구 장소
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Illinois
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Addison, Illinois, 미국, 60101
- Provident Clinical Research
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Subject is a male or pre-menopausal female, 35-50 years, inclusive. Post-menopausal is defined as a history of spontaneous amenorrhea for a period of 12 consecutive months or six weeks post-surgical bilateral oophorectomy, with or without hysterectomy.
- Subject is willing to maintain his or her habitual diet and usual physical activity patterns throughout the study.
- Subject has no health conditions that would prevent him/her from fulfilling the study requirements as judged by the Investigator on the basis of medical history and routine laboratory test results.
- Subject has a body mass index (BMI) of ≥20.00 and <30.00 kg/m2
- Subject is willing to refrain from consuming alcohol 24 h prior to test days.
- Subject is willing to refrain from consuming caffeine and caffeine-containing products 12 h prior to test days.
- Subject is willing to refrain from vigorous physical activity 12 h prior to test days.
- Subject is a non-smoker.
- Subject understands the study procedures and signs forms providing informed consent to participate in the study and authorization for release of relevant protected health information to the study Investigator.
Exclusion Criteria:
- Subject has a positive drug screening of amphetamines, barbiturates, benzodiazepines, cannabis, cocaine, methamphetamines, methadone, 3,4-methylenedioxymethamphetamine, opiates or tricyclic antidepressants at screening.
- Subject has abnormal laboratory test results of clinical significance, including, but not limited to: creatinine ≥1.5 mg/dL, or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥1.5X the upper limit of normal at screening.
- Subject has donated more than 300 mL of blood during the three months prior to screening.
- Subject has uncontrolled hypertension (systolic blood pressure ≥160 mm Hg or diastolic blood pressure ≥100 mm Hg) as defined by the average blood pressure measured at screening. One re-test will be allowed on a separate day prior to visit 2, day 0 for subjects whose blood pressure exceeds either of these cut points at visit 1.
- Subject has a history or presence of clinically important cardiac, renal, hepatic, endocrine (including diabetes mellitus), pulmonary, biliary, gastrointestinal, pancreatic, or neurologic disorders that, in the judgment of the Investigator, would interfere with the subject's ability to provide informed consent, comply with the study protocol (which might confound the interpretation of the study results), or put the subject at undue risk.
- Subject has a history, in the judgment of the Investigator, of a psychological illness or condition such as to interfere with the subject's ability to understand the requirements of the study.
- Use of any sleep aid medication within four days prior to each test day.
- Subject has a history or presence of cancer in the prior two years, except for non-melanoma skin cancer.
- Subject is pregnant, planning to be pregnant during the study period, lactating, or women of childbearing potential who are unwilling to commit to the use of a medically approved form of contraception throughout the study period. The method of contraception must be recorded in the source documentation.
- Excessive habitual caffeine consumption (>300 mg caffeine/d or ≥3 cups of caffeinated coffee/d), following screening and throughout the study period.
- Use of any psychotropic medication within four weeks of screening and throughout the study.
- Use of antibiotics or signs of active systemic infection. Treatment visits will be rescheduled to allow the subject to wash off of the antibiotic for at least five days prior to any test visit.
- Subject has had exposure to any non-registered drug product within 30 days prior to the screening visit.
- Use of dietary supplements containing any of the following: ginkgo biloba, St. John's wort, ginseng, gotu kola (Indian pennywort); daily doses of vitamin E (≥30 mg/d) or folic acid (≥400 ug/d); thiamine, riboflavin, and/or pyridoxine (≥2 mg/d); and eicosapentaenoic acid (EPA), docosahexaenoic acid or a combination of EPA + DHA (≥500 mg/d) within 2 weeks of screening visit.
- Recent history of (within 12 months of screening visit 1) or strong potential for alcohol or substance abuse. Alcohol abuse is defined as >14 drinks per week (1 drink = 12 oz beer, 5 oz wine, or 1½ oz distilled spirits).
- Subject has a known allergy or sensitivity to study product or any ingredients of the study product or meals provided.
- The subject is unable to perform the tests on the CDR System during training to the established acceptable levels for participation in this type of study.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 삼루타
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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위약 비교기: 위약
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1 capsule of placebo twice a day
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실험적: oréVida™ 60mg/day
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1 capsule 30 mg oréVida™ twice a day (one in the morning, one in the afternoon, so in total 60 mg/day)
1 capsule 60 mg oréVida™ twice a day (one in the morning, one in the afternoon, so in total 120mg/day)
1 capsule 120 mg oréVida™ in the morning, one placebo capsule in the afternoon (si in total 120 mg/day)
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실험적: oréVida™ 120mg/day (1)
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1 capsule 30 mg oréVida™ twice a day (one in the morning, one in the afternoon, so in total 60 mg/day)
1 capsule 60 mg oréVida™ twice a day (one in the morning, one in the afternoon, so in total 120mg/day)
1 capsule 120 mg oréVida™ in the morning, one placebo capsule in the afternoon (si in total 120 mg/day)
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실험적: oréVida™ 120mg/day (2)
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1 capsule 30 mg oréVida™ twice a day (one in the morning, one in the afternoon, so in total 60 mg/day)
1 capsule 60 mg oréVida™ twice a day (one in the morning, one in the afternoon, so in total 120mg/day)
1 capsule 120 mg oréVida™ in the morning, one placebo capsule in the afternoon (si in total 120 mg/day)
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Vigilance, Attention, and Concentration Tasks
기간: 4 times one day (at each test day, tasks 13 times repeated)
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Cognitive Drug Research (CDR) Test Battery Attention:
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4 times one day (at each test day, tasks 13 times repeated)
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Working Memory & Executive Function Tasks
기간: 4 times one day (at each test day, tasks 7 times repeated)
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CDR Test Battery Memory:
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4 times one day (at each test day, tasks 7 times repeated)
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Episodic Secondary Memory Tasks
기간: 4 times one day (at each test day, tasks 7 times repeated)
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CDR Test Battery Memory:
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4 times one day (at each test day, tasks 7 times repeated)
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Additional Measurements / Questionnaires
기간: 4 times one day (at each test day, VAS 13 times repeated / POMS 3 times repeated)
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4 times one day (at each test day, VAS 13 times repeated / POMS 3 times repeated)
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공동 작업자 및 조사자
수사관
- 수석 연구원: Kathleen Kelley, MD, Provident Clinical Research
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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. .
oréVida™에 대한 임상 시험
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London Health Sciences CentreUniversity of Western Ontario, Canada; Synaptive Medical알려지지 않은뇌 손상, 만성 | Cerebellar Cognitive Affective Syndrome | 소뇌 함묵증
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Andrew ParrentUniversity of Western Ontario, Canada; Synaptive Medical알려지지 않은
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CereVasc IncAlvaMed, Inc.; Simplified Clinical Data Systems, LLC; Bioscience Consulting, Inc.모병
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Medtronic Cardiovascular모집하지 않고 적극적으로대 동맥류독일, 뉴질랜드, 미국, 네덜란드, 스위스, 영국, 스페인, 호주, 이탈리아, 스웨덴, 프랑스, 오스트리아, 슬로바키아
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Asklepios Kliniken Hamburg GmbHUniversity of Kiel완전한기도 관리 | 후두 마스크 기도 | 광섬유 삽관법
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Boston Scientific Corporation완전한일시적 허혈 발작 | 혈전색전성 뇌졸중 | 뇌졸중 예방미국, 아르헨티나, 독일
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Medtronic CardiovascularMedtronic완전한