Second Meal Effects of a Wholegrain Cereal Product on Blood Glucose Response
2022년 6월 29일 업데이트: Aventure AB
The aim of this study is to investigate second meal effects of a wholegrain cereal product on blood glucose response.
The wholegrain cereal product will be consumed in the evening and blood glucose analyzed after a standardized breakfast meal the following morning.
연구 개요
상태
완전한
정황
연구 유형
중재적
등록 (실제)
17
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Lund, 스웨덴
- Aventure AB
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
35년 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
Inclusion Criteria:
- Male or Female, 35 to 65 years of age
- BMI 18.5-29.9 kg/m2
- Agree to maintain consistent dietary habits and physical activity levels for the duration of the study.
- Healthy as determined by medical history and information provided by the volunteer.
- Willingness to complete questionnaires and follow instructions associated with the study and to complete all visits.
- Has given voluntary, written, informed consent to participate in the study.
Exclusion Criteria:
- Elevated fasting blood glucose (above 6.1 mmol/L at fasting on visit 1, 2, 3 or 4)
- Women who are pregnant or breast feeding
- Any medical condition(s) or medication(s) known to significantly affect glucose metabolism. Significance to be assessed by the QI
- Use of medication, over-the-counter medication, natural health products or dietary supplements/probiotics that may affect glucose metabolism is prohibited during this study. Significance to be assessed by the QI. Participants who are taking allowed prescribed medications must agree to maintain their current method and dosing regimen during the course of the study unless other is recommended by their physician.
- Known Type I or Type II diabetes, including women who previously have had gestational diabetes.
- Use of antibiotics within 2 weeks of enrollment
- Metabolic diseases and/or chronic gastrointestinal diseases (IBS, Crohns etc.)
- Allergy to ingredients included in investigational product, reference, or standardized meal
- Participants restricted to a vegetarian or vegan diet
- Intolerance to gluten
- Individuals who are averse to venous catheterization or capillary blood sampling
- Currently active smokers (or using other tobacco products, and e-cigarettes)
- Unstable medical conditions as determined by QI
- Participation in other clinical research trials
- Individuals who are cognitively impaired and/or who are unable to give informed consent
- Acute infection
Any other condition which in the QI's opinion may adversely affect the individual's ability to complete the study or its measures or which may pose significant risk to the individual
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공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
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: Reference
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This intervention is based on white rice.
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활성 비교기: Whole cereal kernels Dose A
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This wholegrain intervention contains whole cereal kernels.
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활성 비교기: Whole cereal kernels Dose B
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This wholegrain intervention contains whole cereal kernels.
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활성 비교기: Cut cereal kernels Dose A
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This wholegrain intervention contains cut cereal kernels.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Postprandial capillary blood glucose iAUC (0-120 min)
기간: Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
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The change in capillary blood glucose between wholegrain products and reference in the total incremental area under the curve iAUC(0-120 min) after the standardized breakfast meal.
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Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Postprandial capillary blood glucose Cmax
기간: Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
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The change in capillary blood glucose between wholegrain products and reference in 2-hour Cmax(0-120 min) (maximum concentration) after the breakfast meal.
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Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
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Postprandial capillary blood glucose Tmax
기간: Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
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The change in capillary blood glucose between wholegrain products and reference in 2-hour Tmax(0-120 min) (the time to maximum concentration) after the breakfast meal.
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Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
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Fasting capillary blood glucose
기간: Outcome measures will be assessed just before the standardized meal is consumed.
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The change in fasting capillary blood glucose the morning after consuming either wholegrain products or reference.
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Outcome measures will be assessed just before the standardized meal is consumed.
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Postprandial capillary blood glucose iAUC (0-60 min)
기간: Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
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The change in capillary blood glucose between wholegrain products and reference in the 1-hour incremental area under the curve iAUC(0-60 min) after the standardized breakfast meal.
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Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
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Postprandial capillary blood glucose 2-hour iPeak(0-120 min) (incremental maximum value)
기간: Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
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The change in capillary blood glucose between wholegrain products and reference in the 2-hour iPeak(0-120 min) (incremental maximum value) after the breakfast meal.
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Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
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Postprandial Insulin iAUC(0-120 min)
기간: Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
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The change in venous blood insulin between wholegrain products and reference in the total incremental area under the curve iAUC(0-120 min) after the standardized breakfast meal.
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Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
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Postprandial Insulin Cmax
기간: Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
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The change in venous blood insulin between wholegrain products and reference in Cmax after the standardized breakfast meal.
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Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
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Postprandial Insulin Tmax
기간: Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
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The change in venous blood insulin between wholegrain products and reference in Tmax after the standardized breakfast meal.
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Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
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Fasting Insulin
기간: Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
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The change in fasting venous blood insulin the morning after consuming either wholegrain products or reference.
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Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
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Postprandial insulin iAUC (0-60 min)
기간: Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
|
The change in venous blood insulin between wholegrain products and reference in the 1-hour incremental area under the curve iAUC(0-60 min) after the standardized breakfast meal.
|
Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
|
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Postprandial venous blood insulin 2-hour iPeak(0-120 min) (incremental maximum value)
기간: Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
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The change in venous blood insulin between wholegrain products and reference in the 2-hour iPeak(0-120 min) (incremental maximum value) after the breakfast meal.
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Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Fasting GLP-1
기간: Outcome measures will be assessed just before the standardized meal is consumed.
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The change in fasting GLP-1 the morning after consuming either wholegrain products or reference.
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Outcome measures will be assessed just before the standardized meal is consumed.
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GLP-1 iAUC(0-120 min)
기간: Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
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The change in GLP-1 between wholegrain products and reference in the total incremental area under the curve iAUC(0-120 min) after the standardized breakfast meal.
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Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
|
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GLP-1 iAUC(0-60 min)
기간: Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
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The change in GLP-1 between wholegrain products and reference in the1-hour incremental area under the curve iAUC(0-60 min) after the standardized breakfast meal.
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Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
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GLP-1 Cmax
기간: Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
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The changein GLP-1 between wholegrain products and reference in Cmax after the standardized breakfast meal.
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Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
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GLP-1 Tmax
기간: Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
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The change in GLP-1 between wholegrain products and reference in Tmax after the standardized breakfast meal.
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Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
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Fasting PYY
기간: Outcome measures will be assessed just before the standardized meal is consumed.
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The change in fasting PYY the morning after consuming either wholegrain products or reference.
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Outcome measures will be assessed just before the standardized meal is consumed.
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PYY 2-hour mean concentration
기간: Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
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The change in PYY between the wholegrain products and the reference in the 2-hour mean concentration after the breakfast meal.
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Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
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PYY 1-hour mean concentration
기간: Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
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The change in PYY between the wholegrain products and the reference in the 1-hour mean concentration after the breakfast meal.
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Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
스폰서
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2022년 3월 17일
기본 완료 (실제)
2022년 6월 13일
연구 완료 (실제)
2022년 6월 13일
연구 등록 날짜
최초 제출
2022년 3월 14일
QC 기준을 충족하는 최초 제출
2022년 3월 14일
처음 게시됨 (실제)
2022년 3월 23일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2022년 7월 5일
QC 기준을 충족하는 마지막 업데이트 제출
2022년 6월 29일
마지막으로 확인됨
2022년 3월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- TSP2201
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
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. .
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-
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-
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-
The University of Texas Health Science Center at...Hearing Center of Excellence모병
-
Virginia Polytechnic Institute and State UniversityRoswell Park Cancer Institute모병
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