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临床试验/NCT07831603
NCT07831603尚未招募不适用

Stearic Acid and Endothelial Function

Florida State University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2026年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
40
试验地点
1
主要终点
Postprandial Endothelial Function after a Stearic Acid vs Oleic Acid Test Meal

研究概览

简要总结

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:

  1. Does consuming a high stearic acid-rich meal improve postprandial vascular function compared to a high oleic acid-rich meal?
  2. Does a 14-day stearic acid-rich diet improve fasting vascular function compared to an oleic acid-rich diet?
  3. 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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
40 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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
  • Unwilling or unable to provide consent
  • Unwilling or unable to consume study diet

研究组 & 干预措施

Stearic Acid

Experimental

干预措施: High Palmitic Acid Diet (Other)

Stearic Acid

Experimental

干预措施: Stearic Acid Test Meal (Other)

Stearic Acid

Experimental

干预措施: High Stearic Acid Diet (Other)

Stearic Acid

Experimental

干预措施: Palmitic Acid Test Meal (Other)

Oleic Acid

Active Comparator

干预措施: High Palmitic Acid Diet (Other)

Oleic Acid

Active Comparator

干预措施: Oleic Acid Test Meal (Other)

Oleic Acid

Active Comparator

干预措施: High Oleic Acid Diet (Other)

Oleic Acid

Active Comparator

干预措施: Palmitic Acid Test Meal (Other)

结局指标

主要结局

Postprandial Endothelial Function after a Stearic Acid vs Oleic Acid Test Meal

时间窗: 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

次要结局

  • Fasting Long-Term Changes Endothelial Function(Fasting FMD measured on day 15 after the oleic acid and stearic acid diets)
  • Postprandial Endothelial Function after Palmitic Acid Challenge Meal(Day 15 after the high oleic acid and stearic acid diets, following the palmitic acid test meal)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Will Mumby

Graduate Assistant

Florida State University

研究点 (1)

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