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NCT Number: NCT07831603

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:

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.

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Key information

Conditions

Healthy Middle-aged Subjects Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity & Overweight Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

High Palmitic Acid Diet

Other

On this intervention, participants will be given a diet rich in palmitic acid (~35% kcal/d palm stearin) for 14 days.

Stearic Acid Test Meal

Other

Participants will be given a test meal containing 50 g of stearic acid-rich (~90/~10% cocoa butter / high-linoleic sunflower oil) fat.

Oleic Acid Test Meal

Other

Participants will be given a test meal with 50 g of oleic acid-rich (~55/~45% palm olein / high-oleic sunflower oil) fat.

High Stearic Acid Diet

Other

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.

High Oleic Acid Diet

Other

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.

Palmitic Acid Test Meal

Other

Participants will be given a test meal containing 50 g of stearic acid-rich (50g palm oil) fat.

Primary outcomes

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

    Time frame: 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

Secondary outcomes

  1. Fasting Long-Term Changes Endothelial Function

    Time frame: Fasting FMD measured on day 15 after the oleic acid and stearic acid diets

    Brachial artery flow-mediated dilation (FMD) as measured in % dilation

  2. Postprandial Endothelial Function after Palmitic Acid Challenge Meal

    Time frame: Day 15 after the high oleic acid and stearic acid diets, following the palmitic acid test meal

    Brachial artery flow-mediated dilation (FMD) as measured in % dilation

Sponsors and collaborators

Lead sponsor

Florida State University

Other

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 21, 2026
Registry last updated
Sep 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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