- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02487537
Immediate and Long-term Induction of Incretin Release by Artificial Sweeteners 2 (ILIAS-2)
Epidemiological data suggest, that not only sugar-based, but also artificially sweetened soft drinks may play a role in the development of diabetes.
Recent studies in animals and humans have shown, that artificial sweeteners (AS) influence metabolic responses after glucose ingestion, possibly alter the intestinal microbiome and even modulate incretin release.
Data on human subjects are sparse and controversial, especially in a long-term manner. We therefore conduct a cross-over study to assess metabolic response to sweetened vs. non-sweetened soft drinks, which are consumed over a period of 4 weeks.
연구 개요
상세 설명
Epidemiological data suggest, that not only sugar-based, but also artificially sweetened soft drinks may play a role in the development of diabetes.
Recent studies in animals and humans have shown, that artificial sweeteners (AS) influence metabolic responses after glucose ingestion, possibly alter the intestinal microbiome and even modulate incretin release.
Data on human subjects are sparse and controversial, especially in a long-term manner. We therefore conduct a cross-over study to assess metabolic response to sweetened vs. non-sweetened soft drinks, which are consumed over a period of 4 weeks. Metabolic assessment will be based on oral glucose tolerance tests.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Brandenburg
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Bergholz-Rehbrücke, Brandenburg, 독일, 14458
- German Institut for Human Nutrition; Department for Clinical Nutrition
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- healthy
Exclusion Criteria:
- no metabolic disorders such as diabetes, hypothyroidism, corticoid therapy, heart or lung disease
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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위약 비교기: Non-sweetened soft drink
4-week-intervention with one liter of custom-made soft drink per day; soft drink does not contain glucose or any kind of sweet tasting substance
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활성 비교기: Sweetened soft drink
4-week-intervention with one liter of custom-made soft drink per day, soft drinks contains an amount of sweetener, which is isosweet compared to 100 g of sucrose in one liter of beverage
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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change in release of GIP
기간: 4 weeks (cross-over)
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change in fasting state and post-glucose release of GIP between the two interventions
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4 weeks (cross-over)
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change in release of GLP-1
기간: 4 weeks (cross-over)
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change in fasting state and post-glucose release of GLP-1 between the two interventions
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4 weeks (cross-over)
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change in release of GLP-2
기간: 4 weeks (cross-over)
|
change in fasting state and post-glucose release of GLP-2 between the two interventions
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4 weeks (cross-over)
|
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change in release of PYY
기간: 4 weeks (cross-over)
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change in fasting state and post-glucose release of PYY between the two interventions
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4 weeks (cross-over)
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change in release of insulin
기간: 4 weeks (cross-over)
|
change in fasting state and post-glucose release of insulin between the two interventions
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4 weeks (cross-over)
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change in combined levels of glucose and insulin, expressed in calculated indices for insulin secretion
기간: 4 weeks (cross-over)
|
change in fasting state and post-glucose insulin secretion between the two interventions
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4 weeks (cross-over)
|
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change in combined levels of glucose and insulin, expressed in calculated indices for insulin sensitivity
기간: 4 weeks (cross-over)
|
change in fasting state and post-glucose insulin sensitivity between the two interventions
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4 weeks (cross-over)
|
공동 작업자 및 조사자
간행물 및 유용한 링크
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 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
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. .