- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01065402
A Study to Evaluate the Efficacy and Safety of PPB-R-203-Based Meal Versus TK9-Based Meal in 20 Patients With Diabetes
A Randomized, Two-Regimen, Crossover, Comparative Study to Evaluate the Efficacy and Safety of PPB-R-203-Based Meal Versus TK9-Based Meal in 20 Patients With Diabetes
연구 개요
상세 설명
연구 유형
등록 (예상)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Hsieh Mei Huei
- 전화번호: 886-8-762-8188
- 이메일: judyie@isredbioresearch.com.tw
연구 장소
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Pingtung, 대만, 900
- 모병
- Pingtung Christian Hospital
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연락하다:
- Chang Daw Ming, Physician
- 전화번호: 2714 886-8-7368686
- 이메일: dawming@gmail.com
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수석 연구원:
- Chuang Lee Ming, Physician
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Diabetes mellitus patient.
- Aged between 20 to 65 years old.
- Informed consent form signed.
Exclusion Criteria:
- A recent history of drug or alcohol abuse.
- Sensitivity to analogous product.
- Serious cardiovascular disorders.
- Participation in another clinical investigation study.
- Ongoing influenza, autoimmune disease and other metabolic diseases.
- Pregnant or lactating women.
- Individuals are judged by the investigators or co-investigator to be undesirable as subjects.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 건강 서비스 연구
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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위약 비교기: TK9-Based Meal
TK9, Taikeng 9, is one commercially available rice manufacture by Yeedon Enterprise Co., Ltd.
TK9-Based Meal is a diet equivalent to daily energy needs as judged by indirect calorimetry and of the same macronutrient composition.
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TK9, Taikeng 9, is one commercially available rice manufacture by Yeedon Enterprise Co., Ltd.
TK9-Based Meal is a diet equivalent to daily energy needs as judged by indirect calorimetry and of the same macronutrient composition.
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실험적: PPB-R-203-Based Meal
PPB-R-203 is manufacture by Pharma Power Biotec Co., Ltd. The composition of PPB-R-203 is resistant starch (RS). By definition, resistant starch (RS) is any starch that is not digested in the small intestine but passes to the large intestine (or the colon). Therefore, resistant starch can be regarded as a component of dietary fiber. RS intake is associated with several changes in metabolism which may confer some health benefits. PPB-R-203-Based is the diet equivalent to daily energy needs as judged by indirect calorimetry and of the same macronutrient composition. |
PPB-R-203 is manufacture by Pharma Power Biotec Co., Ltd.
The composition of PPB-R-203 is resistant starch (RS).
Resistant starch can be regarded as a component of dietary fiber.
Some forms of RS are present naturally in many foods, and average global consumption is estimated at 3-10 g/day.
PPB-R-203-Based is the diet equivalent to daily energy needs as judged by indirect calorimetry and of the same macronutrient composition.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
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The daily blood glucose level will be monitored by the continuous glucose monitoring system (CGMS) device Medtronic MiniMed.
기간: 2 days
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2 days
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공동 작업자 및 조사자
수사관
- 수석 연구원: Chuang Lee Ming, Physician, National Taiwan University Hospital
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (예상)
연구 완료 (예상)
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. .
TK9-Based Meal에 대한 임상 시험
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Qazvin University Of Medical Sciences완전한
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Qazvin University Of Medical Sciences알려지지 않은
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New Jersey Institute of TechnologyChildren's Hospital of Philadelphia; National Eye Institute (NEI); Rutgers University; Salus...모병