Effects of Reduction in Saturated Fat on Cholesterol and Lipoproteins in Lean and Obese Persons
연구 개요
상세 설명
Background: Increased intake of saturated fat may influence LDL cholesterol and other cardiovascular risk factors different in normal weight and obese subjects. Methods: The study is a randomized controlled clinical trial in 84 men and women between 21 to 70 years with normal BMI (25 kg/m2) or obesity (BMI 30-45 kg/m2) and elevated LDL cholesterol (>3.0 mmol/l). Dietary intervention: Randomization will be to one of two balanced weight maintenance Mediterranean-type diets that differ in their fat sources: an intervention diet substituting unsaturated fats from oil and nuts for saturated fats from meat and dairy foods, and a control diet with whole fat dairy and meat with saturated fats that are not fat reduced.
Primary research question: Compare the effect of substitution of unsaturated fat from nuts and oils for saturated fat from meat and dairy foods on serum lipids in normal weight and obese subjects with elevated LDL cholesterol.
Secondary research questions: Compare the effect of substitution of unsaturated fat from nuts and oils for saturated fat on cardiometabolic risk factors including insulin resistance, inflammation and serum PCSK9 in normal weight and obese individuals.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Oslo, 노르웨이, 0424
- Oslo universitetssykehus, Ullevål
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Men and women aged 21 to 70 years with normal BMI (25 kg/m2) or obesity (BMI 30-45 kg/m2) and elevated LDL cholesterol (> 3.0 mmol/l).
Exclusion Criteria:
- Diabetes types 1 and 2
- History of CVD including myocardial infarction, percutaneous coronary intervention (PCI), coronary artery bypass grafting (CABG), stroke, transient ischemic attack (TIA) or other atherosclerotic disease, eating disorder and other secondary causes of hyperlipidemia.
- Use of statins or other cholesterol-modifying drugs.
- Genetic lipid disorder.
- Gastrointestinal disorders that limit food choices.
- Psychiatric illness, drug or alcohol abuse.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: unsaturated fat
an intervention diet substituting unsaturated fats from oil and nuts for saturated fats from meat and dairy foods
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Substituting unsaturated fat for saturated fat
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활성 비교기: saturated fat
a control diet with whole fat dairy and meat with saturated fats that are not fat reduced.
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a control diet with whole fat dairy and meat with saturated fats that are not fat reduced
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Serum lipids in normal weight and obese subjects with elevated LDL cholesterol.
기간: 10 weeks
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Compare the effect of substitution of unsaturated fat from nuts and oils for saturated fat from meat and dairy foods on serum lipids in normal weight and obese subjects with elevated LDL cholesterol.
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10 weeks
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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C-reactive protein in normal weight and obese individuals
기간: 10 weeks
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Compare the effect of substitution of unsaturated fat from nuts and oils for saturated fat on c-reactive protein in normal weight and obese individuals
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10 weeks
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Serum PCSK9 in normal weight and obese individuals
기간: 10 weeks
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Compare the effect of substitution of unsaturated fat from nuts and oils for saturated fat on inflammation in normal weight and obese individuals
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10 weeks
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Fasting glucose and HbA1C
기간: 10 weeks
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Compare the effect of substitution of unsaturated fat from nuts and oils for saturated fat on fasting glucose and HbA1C
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10 weeks
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공동 작업자 및 조사자
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 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 1786 (REK(
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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