Fat Effects in Women With Metabolic Syndrome (FEMMES II)
Among 10 premenopausal women with Metabolic Syndrome:
Specific Aim 1: Compare the effects of acute fat feeding on flow mediated dilation (FMD) as measured by brachial artery reactivity among three fat challenges (saturated fat vs. monounsaturated fat (MUFA) vs. polyunsaturated fat (PUFA)at 4 hours post feeding. Hypothesis Saturated fat feeding will impair FMD but MUFA and PUFA feeding will not.
Specific Aim 2: Compare the effects of acute feeding on vascular inflammation as measured by VCAM and sICAM among three fat challenges at 3 1/2 hours post feeding.
Hypothesis: Saturated fat feeding will increase vascular inflammation but MUFA and PUFA will not.
연구 개요
연구 유형
등록 (예상)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Washington
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Seattle, Washington, 미국, 98104
- University of Washington
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Female,
- 18-50 years of age,
- Pre-menopausal,
- Weight stable for at least 3 months,
- Not planning to lose or gain weight for 3 months,
Meets the following 3/5 criteria for metabolic syndrome:
- increased blood sugar
- increased blood fats (triglycerides),
- increased blood pressure,
- decreased good cholesterol (HDL-C).
- increased waist circumference,
Exclusion Criteria:
- History of diabetes mellitus
- Fasting glucose ≥ 126 mg/dL
- History of cardiovascular disease (peripheral vascular disease, coronary artery disease, cerebrovascular disease)
- Pregnant or planning a pregnancy within the study period
- Fasting triglycerides > 500 mg/dL
- Currently taking lipid lowering medications**
- Oral or patch hormone contraception**
- Currently taking vaso-active (blood pressure) medications**
- SBP ≥ 140 and/or DBP ≥90 mm Hg or taking blood pressure lowering Rx
- Chronic use of aspirin (prn use is allowed)
- Chronic use of non-steroidal anti-inflammatory medications (prn use is allowed)
- Tobacco use within 6 months of starting study
- Participation in another clinical trial within the last 30 days
- History of active gall bladder disease
- History of digestive or malabsorptive disease requiring treatment or surgery
- Moderate to severe lactose intolerance
- Milk Allergy
- Walnut Allergy or Nut Allergy
- Coconut allergy
(**) Drugs within the following classifications are exclusionary: Lipid lowering, beta blockers, ACE inhibitors, angiotensin receptor blockers, diuretics, calcium channel blockers, alpha blockers, nitrates, hormone contraception includes patch or oral hormone contraception (Hormone containing IUDs or vaginal rings are okay)
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 삼루타
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: young women with MetS
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Each feeding will consist of 473 mL of nonfat milk and 50 gms oil.
The oil will be high in saturated fat, monounsaturated fat or polyunsaturated fat.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Flow Mediated Dilation at 4 hours post feeding
기간: four hours
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4 hours
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four hours
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2차 결과 측정
결과 측정 |
기간 |
|---|---|
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Adhesion molecules (VCAM and sICAM)
기간: 3 1/2 hours
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3 1/2 hours
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공동 작업자 및 조사자
수사관
- 수석 연구원: Pathmaja Paramsothy, MD, MS, University of Washington
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (예상)
연구 완료 (예상)
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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