- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT03741218
Grape Polyphenols and Second-meal Effect (GRAPESECOND)
Potential Modulatory Effect of Whole Grape on Second-meal Tolerance in Obese Subjects: Role of Polyphenols
연구 개요
상세 설명
Twenty-five subjects with obesity will be were recruited. Detailed inclusion and exclusion criteria are provided below.
The subjects will receive, after overnight fasting, either a monodose of freeze-dried grapes (equivalent to 300 g of fresh grapes) or isocaloric placebo solved in water, together with a high-fat breakfast. Blood samples will be collected before the intake, up to 5 h after breakfast, then a medium-fat lunch will be provided and blood samples will be collected for three additional hours. Both interventions will be separated by two weeks. The following determinations will be performed in blood samples collected at different periods: glucose, insulin, triglycerides, uric acid, viscosity, antioxidant capacity. Additionally, a satiety test will be provided. It is expected that grape supplementation, as compared with an isocaloric placebo, causes significant modifications in all the parameters indicated. Nevertheless, the primary outcome of this study is the area under the curve for glucose after the second meal (300-420 min from basal time).
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Madrid, 스페인, 28040
- Institute of Food Science, Technology and Nutrition, National Research Council (ICTAN-CSIC)
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Obesity (BMI = 30-40 kg/m2).
Exclusion Criteria:
- Subjects with a pharmaceutical treatment set to modify blood pressure, lipid profile or glucose.
- Subjects with diagnoses of type 2 diabetes, cardiovascular diseases or thyroid diseases.
- Values above the following ones: glucose, > 115 mg/dL; triglycerides, > 350 mg/dL; total cholesterol, > 280 mg/dL; systolic blood pressure, > 150 mmHg; diastolic blood pressure, > 100 mmHg
- Previous bariatric surgery.
- Volunteers participating in other studies (currently or during last year) or weight loss plans.
- Pregnant or breastfeeding women.
- Adherence to vegetarian diets or usual consumption of dietary supplements.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 기초 과학
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 1
All subjects will receive a high-fat breakfast and a medium-fat lunch twice.
They will consume together with the breakfast the placebo (PLA) the first time and grape (GRAP) the second time.
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The subjects will receive, after overnight fasting, either a monodose of freeze-dried grapes (equivalent to 300 g of fresh grapes) or isocaloric placebo solved in water, together with a high-fat breakfast.
Blood samples will be collected before the intake, up to 5 h after breakfast, then a medium-fat lunch will be provided and blood samples will be collected for three additional hours.
A total of 10 samples will be collected: 0-30-60-120-180-240-300-330-360-420 min.
Both interventions will be separated by two weeks.
Subjects will be instructed not to modify their dietary habits during the development of the study, but during the 72 h before each visit they will have to restrict the intake of polyphenol-rich foods (a detailed list will be provided).
|
실험적: 2
All subjects will receive a high-fat breakfast and a medium-fat lunch twice.
They will consume together with the breakfast grape (GRAP) the first time and the placebo (PLA) the second time.
|
The subjects will receive, after overnight fasting, either a monodose of freeze-dried grapes (equivalent to 300 g of fresh grapes) or isocaloric placebo solved in water, together with a high-fat breakfast.
Blood samples will be collected before the intake, up to 5 h after breakfast, then a medium-fat lunch will be provided and blood samples will be collected for three additional hours.
A total of 10 samples will be collected: 0-30-60-120-180-240-300-330-360-420 min.
Both interventions will be separated by two weeks.
Subjects will be instructed not to modify their dietary habits during the development of the study, but during the 72 h before each visit they will have to restrict the intake of polyphenol-rich foods (a detailed list will be provided).
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Postprandial glucose (300-420 min)
기간: Up to two months
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Changes of postprandial blood glucose as result of supplementation with grapes, measured area under the curve for the period 300-420 min
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Up to two months
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Postprandial glucose and insulin
기간: Up to four months
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Changes of blood glucose (0-320 min) and insulin (0-300 and 300-420 min) as result of supplementation with grapes
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Up to four months
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Plasma triglycerides
기간: Up to four months
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Changes of plasma triglycerides (0-300 and 300-420 min) as result of supplementation with grapes
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Up to four months
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Plasma uric acid
기간: Up to four months
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Changes of plasma uric acid (0-300 and 300-420 min) as result of supplementation with grapes
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Up to four months
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Plasma antioxidant capacity
기간: Up to five months
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Changes of plasma antioxidant capacity (0-300 and 300-420 min) as result of supplementation with grapes
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Up to five months
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Plasma viscosity
기간: Up to six months
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Changes of plasma viscosity (0-300 and 300-420 min) as result of supplementation with grapes.
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Up to six months
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Satiety
기간: Up to three months
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Changes of satiety (0-300 and 300-420 min) as result of supplementation with grapes.
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Up to three months
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공동 작업자 및 조사자
수사관
- 수석 연구원: Jara Pérez-Jiménez, PhD, Institute of Food Science, Technology and Nutrition (ICTAN-CSIC)
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 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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