- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT04278209
Glycogen Metabolism in Children
Measurement of Glycogen Replenishment in Children After an Overnight Fast
연구 개요
상세 설명
The aim of the study is to investigate if liver and muscle glycogen stores are depleted in children after overnight fasting and to what extend the stores are replenished with the intake of small breakfast.
The study is a balanced incomplete crossover design. Participants (children between 8 and 12 years old) have to be two periods of two days in the study. They will be randomized in 6 arms, receiving either water, 1 serving of a small breakfast (Breakfast 1) or 2 servings of the small breakfast (Breakfast 2).
An Interim Analysis after 9 completed subjects will be performed in order to calculate the total number of subjects needed to adequately power the Primary Endpoint.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Nottingham, 영국, NG7 2RD
- University of Nottingham Medical School
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Healthy girls and boys between 8 and 12 years of age
- Clinically healthy body weight (5 to 85th rounded percentile from UK)
- In good health as determined by health screening questionnaires
- English proficiency as per investigator judgment
- Informed consent signed by parent(s), or legal representative if applicable and signed child assent according to local legislation
Exclusion Criteria:
- Girls having menstruations
- Any type of self-reported food allergies
- Lactose intolerance
- Claustrophobic
- Diagnosis of Diabetes Mellitus
- Diagnosed acute or chronic medical conditions that could impact study outcomes (asthma)
- Ongoing diseases or intake of any prescribed or over the counter drugs
- Participants or participants' parent(s) or legal representative who are not willing and not able to comply with scheduled visits and the requirements of the study protocol (including a consumption of 200 ml study drink)
- Currently participating or having participated in another clinical trial within 12 weeks prior to trial start.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 기초 과학
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
실험적: Breakfast 1 - Breakfast 2
Participants will receive Breakfast 1 then Breakfast 2.
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Participant will receive Breakfast 1
Participant will receive Breakfast 2
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실험적: Breakfast 1 - water
Participants will receive Breakfast 1, then water.
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Participant will receive Breakfast 1
Participant will receive water
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실험적: Breakfast 2 - water
Participants will receive Breakfast 2, then water.
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Participant will receive Breakfast 2
Participant will receive water
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실험적: Breakfast 2 - Breakfast 1
Participants will receive 2 servings, then 1 serving of the study product.
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Participant will receive Breakfast 1
Participant will receive Breakfast 2
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실험적: Water - Breakfast 1
Participants will receive water, then Breakfast 1.
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Participant will receive Breakfast 1
Participant will receive water
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실험적: Water - Breakfast 2
Participants will receive water, then Breakfast 2.
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Participant will receive Breakfast 2
Participant will receive water
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Incremental/decremental AUC0-240 of the concentration/time curve of hepatic glycogen
기간: 4 hours
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To determine the effects of 1 and 2 servings of a small breakfast on hepatic glycogen stores; measured by NMR
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4 hours
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Change of hepatic glycogen content over an overnight fast
기간: 12 hours
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Change of hepatic glycogen content over an overnight fast
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12 hours
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Change of muscle glycogen content over an overnight fast
기간: 12 hours
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Change of muscle glycogen content over an overnight fast
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12 hours
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Incremental/decremental AUC0-240 of the concentration/time curve of muscle glycogen
기간: 4 hours
|
To determine the effects of 1 and 2 servings of a small breakfast on muscle glycogen stores; measured by NMR
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4 hours
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공동 작업자 및 조사자
스폰서
수사관
- 수석 연구원: Liz Simpson, PhD, University of Nottingham Medical School
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
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
- 1906NRC
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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