- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01064778
Glycemic Index and Brain Function
The Effects of Dietary Glycemic Index on Brain Function
연구 개요
상세 설명
Most individuals have great difficulty following reduced calorie diets because they experience increased hunger. This process is regulated by specific brain areas. Though many psychological and environmental factors are involved, physiological effects of diet may have a significant impact. The postprandial rise in blood glucose, quantified by the glycemic index (GI), is of particular interest. High GI meals elicit hormonal events that limit availability of metabolic fuels, causing hunger and overeating, especially in people with high insulin secretion.
Our aim is to examine how postprandial changes after high versus low GI meals affect hunger and brain function in areas of intake control. Specifically, we speculate that obese individuals will demonstrate functional changes in brain areas of intake control and increased hunger after a high versus low GI meal.
We will recruit obese, young adults and quantify their insulin secretion during a 2-hour oral glucose tolerance test. A brief practice MRI session will serve to familiarize the subjects with the scanning process. During the two test sessions, standardized test meals with high versus low GI will be given in a randomized, blinded cross-over design. Serial blood levels of hormones, metabolic fuels, and metabolites will be correlated with perceived hunger, and a perfusion MRI scan will be performed to assess brain activation during the late postprandial phase, at the nadir of blood sugar and insulin levels (4 hours postprandial).
This work will inform an integrated physiological model relating peripheral postprandial changes to brain function and hunger. In addition, findings may provide evidence of a novel diet-phenotype, in which baseline clinical characteristics can be used to predict which weight loss diet will work best for a specific individual. Metabolite profiling might shed light on the mechanisms linking diet composition to brain function, and provide feasible clinical markers of the identified phenotype to facilitate translation into practice.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Massachusetts
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Boston, Massachusetts, 미국, 02215
- Beth Israel Deaconess Medical Center
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Boston, Massachusetts, 미국, 02115
- Children's Hospital Boston
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Boston, Massachusetts, 미국, 02215
- Brigham and Women's Hospital
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion criteria
- Males age 18 to 35 years
- BMI less than or equal to 25 for age and gender
Exclusion criteria
- weight > 300 lbs
- largest body circumference > 144cm
- body shape incompatible with MRI scanner or equipment
- MRI exclusion criteria
- large fluctuations in body weight (5% over preceding 6 months, 2.5% during the study)
- known medical problems that may affect metabolism or hormones
- diabetes mellitus (fasting plasma glucose ≥126 mg/dL)
- other abnormal laboratory screening tests
- taking any medications or dietary supplements that might affect body weight, appetite, or energy expenditure
- smoking or illicit substance abuse
- high levels of physical activity (>30 minutes per day, > 4days per week)
- currently following a weight loss diet
- allergies or intolerance to eggs, vanilla extract, equal, canola oil, milk, cornstarch, corn syrup
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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활성 비교기: Low GI
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Subjects will be instructed to consume a liquid test meal with a low GI over 5 minutes after baseline laboratory evaluations.
The low and high GI meal contain similar amounts of milk, oil, dried egg whites, equal, and vanilla extract.
The low GI meal corn-starch as a carbohydrate.
Both meals have similar macronutrient composition (60% carbohydrate, 15% protein, 25% fat), micronutrient profiles, physical properties, palatability and sweetness.
The high vs. low GI meals have a predicted difference in GI of 90 vs. 40, and consistent with this prediction, a pilot study in obese young adults found a 2.2-fold difference in glycemic response (p<0.001).
The test meals will provide 25% of individual daily energy requirements.
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실험적: High GI
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Subjects will be instructed to consume a liquid test meal with a high GI over 5 minutes after baseline laboratory evaluations.
The low and high GI meal contain similar amounts of milk, oil, dried egg whites, equal, and vanilla extract.
The high GI meal contains corn-syrup as a carbohydrate.
Both meals have similar macronutrient composition (60% carbohydrate, 15% protein, 25% fat), micronutrient profiles, physical properties, palatability and sweetness.
The high vs. low GI meals have a predicted difference in GI of 90 vs. 40, and consistent with this prediction, a pilot study in obese young adults found a 2.2-fold difference in glycemic response (p<0.001).
The test meals will provide 25% of individual daily energy requirements.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
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Blood Flow in Brain Areas of Intake Control.
기간: 4 hours postprandial
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4 hours postprandial
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Subjective Hunger Rating
기간: Every 30 minutes for 5 hours.
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Every 30 minutes for 5 hours.
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Blood Glucose Level
기간: Every 30 minutes for 5 hours.
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Every 30 minutes for 5 hours.
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Blood Insulin Level
기간: Every 30 minutes for 5 hours
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Every 30 minutes for 5 hours
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Blood Glucagon Level
기간: Every 30 minutes for 5 hours.
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Every 30 minutes for 5 hours.
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Blood Growth Hormone Level
기간: Every 30 minutes for 5 hours.
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Every 30 minutes for 5 hours.
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Blood Epinephrine Level
기간: Every 30 minutes for 5 hours.
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Every 30 minutes for 5 hours.
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Blood Fatty Acids Level
기간: Every 30 minutes for 5 hours.
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measuring metabolite profiles
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Every 30 minutes for 5 hours.
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공동 작업자 및 조사자
수사관
- 연구 책임자: Belinda S Lennerz, MD, PhD, Boston Children's Hospital
- 수석 연구원: David Alsop, PhD, Beth Israel Deaconess Medical Center
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
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 (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. .
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