- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00315354
Popular Diets Study
2016년 11월 22일 업데이트: David S. Ludwig, MD, PhD, Boston Children's Hospital
Popular Diets, Metabolism, and CVD Risk
The aim of this study is to evaluate the effects of three dominant dietary patterns - conventional low-fat, low-glycemic index (GI) and very-low-carbohydrate - on energy metabolism and heart disease risk factors following weight loss in obese young adults in a feeding study
연구 개요
상태
완전한
상세 설명
For most of the last half century, reduction in fat intake has been the primary nutritional approach for the prevention and treatment of obesity and cardiovascular disease (CVD).
Over the last few years, very low carbohydrate (Atkins-type) diets have achieved great popularity, with publication of several studies suggesting greater weight loss and improvements in CVD risk factors over 3 to 6 months.
Recently, a third dietary approach focused on glycemic index (GI) has generated interest.
However, few studies have compared the effects of these diets on body weight regulation and risk for CVD.
The primary hypotheses of this study are that any diet that lowers the postprandial rise in blood glucose (very-low-carbohydrate or low-GI) will have beneficial effects on the physiological adaptations to weight loss and on some CVD risk factors.
However, other CVD risk factors will be adversely affected by a very-low-carbohydrate vs. a low-GI diet.
Preliminary data provide strong support for these hypotheses, by showing that resting energy expenditure declines less and CVD risk factors improve more with weight loss on a low-glycemic load diet compared to a conventional low-fat diet.
This application proposes a cross-over feeding design to study the effects of three diets following 12.5% weight loss in obese young adult subjects (n = 24, age 18 to 40 years).
The diets are: 1) conventional low-fat, with 60% carb, 20% fat, 20% protein; 2) low-GI with 40% carb, 40% fat, 20% protein; and 3) very-low-carbohydrate with 10% carb, 60% fat, 30% protein.
The primary outcome is resting energy expenditure (indirect calorimetry).
Secondary outcomes include total energy expenditure (doubly labeled water), thermic effect of food (indirect calorimetry), physical activity (accelerometry), insulin resistance and B-cell function (frequently-sampled OGTT), blood lipids, blood pressure and measures of systemic inflammation and coagulopathy.
This study should have major public health implications to the millions of Americans currently following diets to decrease body weight and risk for heart disease.
연구 유형
중재적
등록 (실제)
24
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
-
-
Massachusetts
-
Boston, Massachusetts, 미국, 02115
- Children's Hospital Boston
-
-
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
18년 (성인)
건강한 자원 봉사자를 받아들입니다
예
연구 대상 성별
모두
설명
Inclusion Criteria:
- BMI ≥ 27 kg/m2
- Willing and able to come to the GCRC 5 days per week to consume a supervised meal and pick-up food for all other meals
- Available for scheduled hospital admissions
- Willing to abstain from alcohol consumption for the duration of the study
- If female, regular menstrual cycles (defined as 26 to 30 days between cycles; no more than one day variation in the duration of menstrual flow)
Exclusion Criteria:
- Weight > 350 lbs
- Change in body weight (± 10%) over preceding year
- Taking any medications or dietary supplements that might affect body weight, appetite, or energy expenditure
- Smoking (1 cigarette in the last week)
- High levels of physical activity
- Currently following a special diet
- Abnormal laboratory screening tests
- Type 2 diabetes mellitus
- Allergies or aversions to foods on the study menu
- Previous diagnosis of an eating disorder or any other mental health disorder
- If female, pregnant in the past 12 months or planning to become pregnant during the study period
- If female, lactating in the preceding 12 months
- If taking birth control medication, change in medication in previous 3 months or plans to change medication during the study period
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: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
활성 비교기: 2
저지방 다이어트
|
Feeding protocol, all foods prepared in a metabolic kitchen
|
|
실험적: 1
Low glycemic index diet
|
Feeding protocol, all foods prepared in a metabolic kitchen
|
|
활성 비교기: 3
Very low carbohydrate diet
|
Feeding protocol, all foods prepared in a metabolic kitchen
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
|
resting energy expenditure using indirect calorimetry in the fasting state
기간: end of each dietary period
|
end of each dietary period
|
|
insulin resistance assessed by frequently-sampled oral glucose tolerance test
기간: end of each dietary period
|
end of each dietary period
|
|
thyroid function tests
기간: end of each dietary period
|
end of each dietary period
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
total energy expenditure using doubly labeled water methodology
기간: end of each dietary period
|
end of each dietary period
|
|
|
thermic effect of food using indirect calorimetry
기간: end of each dietary period
|
end of each dietary period
|
|
|
physical activity using accelerometry
기간: end of each dietary period
|
end of each dietary period
|
|
|
serum lipids
기간: end of each dietary period
|
end of each dietary period
|
|
|
plasminogen activator inhibitor-1
기간: end of each dietary period
|
end of each dietary period
|
|
|
C-reactive protein
기간: end of each dietary period
|
end of each dietary period
|
|
|
blood pressure
기간: end of each dietary period
|
end of each dietary period
|
|
|
hunger/appetite
기간: end of each dietary period
|
end of each dietary period
|
|
|
insulin 30 minutes after oral glucose (as an effect modifier)
기간: baseline
|
baseline
|
|
|
Core temperature
기간: End of each dietary period
|
End of each dietary period
|
|
|
secreted frizzle-related protein-4
기간: end of each dietary period
|
end of each dietary period
|
|
|
heme-oxygenase
기간: end of each dietary period
|
end of each dietary period
|
|
|
Irisin
기간: end of each dietary period
|
end of each dietary period
|
|
|
fibroblast growth factor-21
기간: end of each dietary period
|
end of each dietary period
|
|
|
chemerin
기간: end of each dietary period
|
end of each dietary period
|
|
|
trimethylamine N-oxide
기간: fasting and postprandial, end of each dietary period
|
fasting and postprandial, end of each dietary period
|
|
|
alanine aminotransferase
기간: end of each dietary period
|
end of each dietary period
|
|
|
Uric acid
기간: end of each dietary period
|
end of each dietary period
|
|
|
insulin
기간: fasting and postprandial, end of each dietary period
|
fasting and postprandial, end of each dietary period
|
|
|
ghrelin
기간: fasting and postprandial, end of each dietary period
|
fasting and postprandial, end of each dietary period
|
|
|
gastric inhibitory peptide
기간: fasting and postprandial, end of each dietary period
|
fasting and postprandial, end of each dietary period
|
|
|
GLP1
기간: fasting and postprandial, end of each dietary period
|
fasting and postprandial, end of each dietary period
|
|
|
PYY
기간: fasting and postprandial, end of each dietary period
|
fasting and postprandial, end of each dietary period
|
|
|
Amylin
기간: fasting and postprandial, end of each dietary period
|
fasting and postprandial, end of each dietary period
|
|
|
Leptin
기간: end of each dietary period
|
end of each dietary period
|
|
|
Metabolomic analysis
기간: end of each dietary period
|
Evaluate the effect of diet on metabolomic profile in plasma, with the aim of assessing dietary adherence and exploring diet-disease mechanisms
|
end of each dietary period
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
협력자
수사관
- 연구 책임자: Cara B Ebbeling, PhD, Boston Children's Hospital
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- Walsh CO, Ebbeling CB, Swain JF, Markowitz RL, Feldman HA, Ludwig DS. Effects of diet composition on postprandial energy availability during weight loss maintenance. PLoS One. 2013;8(3):e58172. doi: 10.1371/journal.pone.0058172. Epub 2013 Mar 6.
- Ebbeling CB, Swain JF, Feldman HA, Wong WW, Hachey DL, Garcia-Lago E, Ludwig DS. Effects of dietary composition on energy expenditure during weight-loss maintenance. JAMA. 2012 Jun 27;307(24):2627-34. doi: 10.1001/jama.2012.6607.
- Hron BM, Ebbeling CB, Feldman HA, Ludwig DS. Hepatic, adipocyte, enteric and pancreatic hormones: response to dietary macronutrient composition and relationship with metabolism. Nutr Metab (Lond). 2017 Jul 5;14:44. doi: 10.1186/s12986-017-0198-y. eCollection 2017.
- Esko T, Hirschhorn JN, Feldman HA, Hsu YH, Deik AA, Clish CB, Ebbeling CB, Ludwig DS. Metabolomic profiles as reliable biomarkers of dietary composition. Am J Clin Nutr. 2017 Mar;105(3):547-554. doi: 10.3945/ajcn.116.144428. Epub 2017 Jan 11. Erratum In: Am J Clin Nutr. 2022 Feb 9;115(2):601.
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
2006년 4월 1일
기본 완료 (실제)
2010년 6월 1일
연구 완료 (실제)
2013년 4월 1일
연구 등록 날짜
최초 제출
2006년 4월 14일
QC 기준을 충족하는 최초 제출
2006년 4월 14일
처음 게시됨 (추정)
2006년 4월 18일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
2016년 11월 23일
QC 기준을 충족하는 마지막 업데이트 제출
2016년 11월 22일
마지막으로 확인됨
2016년 11월 1일
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. .