- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02116816
Absorption Profiles of Three Polyphenol Preparations With and Without Pollen Shell Covering
Investigation Into Polyphenol Absorption Profiles
This study consists of two parts. The first part of the study looked at the absorption of three different polyphenol preparations into the blood, the variability of their absorption and whether their absorption could be enhanced by mixing with pollen shells. For this purpose 12 healthy volunteers were recruited. All participants received all the 3 supplements with and without mixing with pollen shells so they had a total of 3 tests. For each test six blood samples were taken over an 8 hour period. Urine samples were also collected.
Oligopin was selected from the first study. The second part of study aims to look at the effects of Oligopin on endothelial function by assessing vascular tone and function in healthy volunteers using a non-invasive, direct measurement of vasodilatory capacity (EndoPAT). Nitrate and nitrite measurements, as well as blood pressure measurements, will also be recorded to provide a clear clinical assessment of the effects of this preparation (if any) upon vascular function. The effects of Oligopin will be compared to a placebo (methylcellulose-filled capsules) to allow a robust assessment of any clinical effects. A total of 24 healthy volunteers will be recruited for this study.
연구 개요
상세 설명
This study consists of two parts. The first part of the study looked at the absorption of three different polyphenol preparations into the blood, the variability of their absorption and whether their absorption could be enhanced by mixing with pollen shells (pollen shells have been shown to enhance lipid molecule absorption). For this purpose 12 healthy volunteers were recruited. All participants received all the 3 supplements with and without mixing with pollen shells so they had a total of 3 tests. For each test six blood samples were taken over an 8 hour period. Urine samples were also collected.
Oligopin was selected from the first study. The second part of study aims to look at the effects of Oligopin on endothelial function by assessing vascular tone and function in healthy volunteers using a non-invasive, direct measurement of vasodilatory capacity (EndoPAT). Nitrate and nitrite measurements, as well as blood pressure measurements, will also be recorded to provide a clear clinical assessment of the effects of this preparation (if any) upon vascular function. The effects of Oligopin will be compared to a placebo (methylcellulose-filled capsules) to allow a robust assessment of any clinical effects. A total of 24 healthy volunteers will be recruited for this study.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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East Yorkshire
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Hull, East Yorkshire, 영국, HU3 2RW
- Michael White Centre for Diabetes and Endocrinology
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Male or Female subjects between the age of 18-65 who can speak and understand English
- No concomitant medication including herbal medicines and food supplements
- No concomitant disease processes
- Body Mass Index 21- 29kg/m2
- Systolic blood pressure ≤150 mm Hg and diastolic pressure <90 mm Hg
- Subjects who have given informed consent
Exclusion Criteria:
- Patients not wishing to allow disclosure to their GPs.
- Concomitant medication including herbal medicines and food supplements
- Concomitant disease processes
- History of drug/alcohol abuse or Alcohol intake within 24 hours of dosing visit (visits 2-4)
- Body Mass Index <21 and > 29kg/m2
- Systolic blood pressure >150 mm Hg and or a diastolic pressure>90 mm Hg
- Unable to tolerate polyphenol products or adhere to low polyphenol diet
- Vegetarian
- Subjects not willing or able to fast until 12 noon (a total of 14 hours).
- Pregnant females or planning to conceive in the next 3 months.
- Participation in any other study currently or in the last three months.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 건강 서비스 연구
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Polyphenol
Polyphenol preparations
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Polyphenol
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Area Under the Absorption Curve for each polyphenol preparation
기간: 8 hours
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Blood samples will be withdrawn 6 times over an 8 hour period: baseline, then 30 minutes, 1 hour, 2 hours, 4 hours and 8 hours after ingestion of each polyphenol supplement (total 3 supplements)
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8 hours
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공동 작업자 및 조사자
수사관
- 수석 연구원: Thozhukat Sathyapalan, MBBS FRCP MD, University of Hull
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 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- Protocol Version 2
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. .