Stearic Acid and Endothelial Function
The goal of this clinical trial is to evaluate the postprandial and long-term effects of dietary stearic acid on vascular function in overweight or obese adult males and females aged 40-70 years. The main questions it aims to answer are:
- Does consuming a high stearic acid-rich meal improve postprandial vascular function compared to a high oleic acid-rich meal?
- Does a 14-day stearic acid-rich diet improve fasting vascular function compared to an oleic acid-rich diet?
- Does a 14-day stearic acid-rich diet reduce the impairment of postprandial vascular function following a high palmitic-acid challenge meal?
Participants will:
- Complete screening questionnaires, a 3-day food log, body composition measurements, and fasting blood and urine tests.
- Consume a provided, 14-day controlled diet high in palmitic acid while avoiding outside food and beverages other than water.
- Be randomly assigned to consume a provided 14-day diet high in either stearic acid (cocoa butter blend) or oleic acid (plant oil blend).
- Attend two 5-hour testing visits at the clinic after overnight fasting.
- Undergo intravenous (IV) catheter placement for repeated blood sampling and non-invasive vascular health assessments (ultrasound artery checks and pulse measurements).
- Consume assigned high-fat test meals within 15 minutes and undergo hourly vascular and blood assessments over a 4-hour period.
연구 개요
상태
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Florida
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Tallahassee, Florida, 미국, 32306
- Florida State University
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연락하다:
- Will Mumby
- 전화번호: 850-644-1829
- 이메일: hnfs-cardionutritionlab@fsu.edu
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Adults ages 40-70 years
- BMI 25.0-40.0 kg/m2
- Seated blood pressure <130/80 mmHg
- Willing and able to attend laboratory visits
Exclusion Criteria:
- Current diagnosis or history of diabetes, renal disease, liver disease, gallbladder disease, cholecystectomy, pancreatic disease, cancer, overt cardiovascular disease, or a major cardiovascular event (e.g., heart attack or stroke)
- Current or recent use of weight loss medications
- Significant change in bodyweight of ≥ 5% within the past 6 months
- Current or recent use of glucose- or lipid-lowering drugs
- Fasting LDL cholesterol ≥ 190 mg/dL or fasting plasma total cholesterol > 7.8 mmol/L (302 mg/dL), or fasting plasma TAG > 3 mmol/L (267 mg/dL)
- Current or recent use of tobacco, nicotine, or illicit drugs
- History of bariatric surgery
- Hysterectomy or ovarian removal (females)
- Pregnant or lactating
- Athlete
- Unwilling or unable to provide consent
- Unwilling or unable to consume study diet
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 기초 과학
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 삼루타
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Stearic Acid
|
On this intervention, participants will be given a diet rich in palmitic acid (~35% kcal/d palm stearin) for 14 days. Participants will be given a test meal containing 50 g of stearic acid-rich (~90/~10% cocoa butter / high-linoleic sunflower oil) fat. Participants will be given a high stearic acid-rich diet (~35% kcal/d ~90/~10% cocoa butter / high-linoleic sunflower oil mixture) for 14 days total. Participants will be given a test meal containing 50 g of stearic acid-rich (50g palm oil) fat. |
|
활성 비교기: Oleic Acid
|
On this intervention, participants will be given a diet rich in palmitic acid (~35% kcal/d palm stearin) for 14 days. Participants will be given a test meal containing 50 g of stearic acid-rich (50g palm oil) fat. Participants will be given a test meal with 50 g of oleic acid-rich (~55/~45% palm olein / high-oleic sunflower oil) fat. Participants will be given a high oleic acid-rich (~35% kcal/d ~55/~45% palm olein / high-oleic sunflower oil mixture) for 14 days total. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Postprandial Endothelial Function after a Stearic Acid vs Oleic Acid Test Meal
기간: Day 1 of the stearic acid and oleic acid diets, after consuming the stearic acid or oleic acid test meals, respectively
|
Brachial artery flow-mediated dilation (FMD) as measured in % dilation after a test meal |
Day 1 of the stearic acid and oleic acid diets, after consuming the stearic acid or oleic acid test meals, respectively
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Fasting Long-Term Changes Endothelial Function
기간: Fasting FMD measured on day 15 after the oleic acid and stearic acid diets
|
Brachial artery flow-mediated dilation (FMD) as measured in % dilation |
Fasting FMD measured on day 15 after the oleic acid and stearic acid diets
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|
Postprandial Endothelial Function after Palmitic Acid Challenge Meal
기간: Day 15 after the high oleic acid and stearic acid diets, following the palmitic acid test meal
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Brachial artery flow-mediated dilation (FMD) as measured in % dilation |
Day 15 after the high oleic acid and stearic acid diets, following the palmitic acid test meal
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
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
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- STUDY00006972
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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