Stearic Acid and Endothelial Function

September 15, 2026 updated by: Will Mumby, Florida State University

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Stearic Acid
Other: High Palmitic Acid Diet

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

Other: Stearic Acid Test Meal

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

Other: High Stearic Acid Diet

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.

Other: Palmitic Acid Test Meal

Participants will be given a test meal containing 50 g of stearic acid-rich (50g palm oil) fat.
Active Comparator: Oleic Acid
Other: High Palmitic Acid Diet

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

Other: Palmitic Acid Test Meal

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

Other: Oleic Acid Test Meal

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

Other: High Oleic Acid Diet

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Day 1 of the stearic acid and oleic acid diets, after consuming the stearic acid or oleic acid test meals, respectively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Fasting FMD measured on day 15 after the oleic acid and stearic acid diets
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
Day 15 after the high oleic acid and stearic acid diets, following the palmitic acid test meal

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Florida State University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2026

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

August 1, 2027

Study Registration Dates

First Submitted

September 15, 2026

First Submitted That Met QC Criteria

September 15, 2026

First Posted (Actual)

September 21, 2026

Study Record Updates

Last Update Posted (Actual)

September 21, 2026

Last Update Submitted That Met QC Criteria

September 15, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00006972

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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