- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02381860
Investigate the Effect of Tart Montmorency Cherry Juice (Prunus Cerasus) on Cerebral Blood Flow and Cognitive Function
연구 개요
상세 설명
Each participant will be required to attend the laboratory on three occasions. The first of these will be an initial screening/training visit, within 14 days of the first active study visit. During the initial visit participants will be provided with written informed consent and screened with regards the study exclusion/inclusion criteria. Training will be given on the cognitive tasks and familiarisation with the study procedures will be provided.
Study days: Forty - eight hours prior to each study day, participants will begin dietary restrictions. Participants will then attend the first study day following an overnight fast. A cannula will be inserted and baseline blood samples obtained, baseline measures of cerebral blood flow will be examined using near infrared spectroscopy and its effect on cognitive function using a cognitive demand battery. The relevant drink will then be provided and blood samples and blood flow measures will be taken at hourly intervals (1, 2, 3, and 5h). No additional food or drink will be provided during the study period except for low-nitrate mineral water. After a minimum of 2 weeks, participants will be asked to return to the lab and repeat the procedure with the other drink.
Cerebrovascular Responses
Cerebral oxygenation will be assessed using near - infrared spectroscopy . Two near-infrared sensors will be placed on the skin over the right and left prefrontal cortex region of the forehead, and the signals were averaged to determine cerebral oxygenation. The sensors will be secured to the skin using double-sided adhesive tape and shielded from ambient light using an elastic bandage. The sensors alternately emit near-infrared light at wavelengths of 730 and 810 nm. Each sensor contains two detectors located at 3 and 4 cm from the emitting source that detect oxygenated and deoxygenated states of Hb to estimate regional O2 saturation based on internal algorithms (Rasmussen et al. 2007).
Blood velocity in the middle cerebral artery (MCAV) will be determined using transcranial Doppler sonography. A 2 MHz Doppler probe was positioned over the right middle cerebral artery using previously described search techniques (Aaslid et al. 1982) and will be secured with an adjustable headset (DiaMon, Compumedics DWL). The mean depth for Doppler signals was 51 ± 3 mm. Arterial blood pressure will be recorded with a transducer located at heart level (TruWave, Edwards Lifesciences, Nyon, Switzerland).
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Newcastle, 영국, NE18ST
- Northumbria University
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Males and females aged 40-60 years
- Not currently taking any medication
Exclusion Criteria:
- Those aged <40 or >60 years
- Currently taking medication
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 삼루타
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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위약 비교기: Placebo
The PLA supplement consisted of a commercially available, less than 5% fruit, cordial (Protein - Trace, Carbohydrate 260 mg•mL-1, Sodium 0.02 mg•mL-1, Fibre-Trace and Anthocyanins-Trace for colour), mixed with water, whey protein isolate (Arla Foods Ltd., Leeds, UK) and maltodextrin (MyProtein Ltd., Northwich, UK) until matched for carbohydrate and calorie content of the MC.
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과일 코디얼이 5% 미만인 한 덩어리에 물, 말토덱스트린 및 분리 유청 단백질을 혼합하여 주스의 탄수화물 및 칼로리 함량과 일치시킵니다.
다른 이름들:
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활성 비교기: 60mL of cherry concentrate with 100ml water
One bolus of 60mL of tart Montmorency cherry (MC) juice mixed with 100mL of water.
Independent analysis of MC (Atlas Biosciences, 2010) provided the following compositional data; Fat 0.028 mg•mL-1, Protein 31.47 mg•mL-1, Carbohydrate 669.4 mg•mL-1, Cholesterol < 0.01 mg•mL-1, Sodium 0.691 mg•mL-1, Calcium 0.137 mg•mL-1 and Iron 0.026 mg•mL-1.
Additionally, according to the manufacturers guidelines (Cherry Active, Hanworth, UK),
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타르트 몽모랑시 농축액 60mL에 물 100mL를 섞은 볼루스 1개.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
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Changes in Cerebral Blood Flow
기간: 0,1,2,3, and 5 hours
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0,1,2,3, and 5 hours
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2차 결과 측정
결과 측정 |
기간 |
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Changes in Cognitive Function
기간: 0,1,2,3 and 5 hours
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0,1,2,3 and 5 hours
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공동 작업자 및 조사자
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. .
위약에 대한 임상 시험
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AJU Pharm Co., Ltd.OM Pharma SA모병
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University Hospital, Strasbourg, France모집하지 않고 적극적으로