Healthy Middle-aged SubjectsNCT07831603
Stearic Acid and Endothelial Function
A study testing High Palmitic Acid Diet, Stearic Acid Test Meal and Oleic Acid Test Meal in people with Healthy Middle-aged Subjects and Obesity & Overweight, run by Florida State University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Middle-aged Subjects, Obesity & Overweight
- What is being tested?
- High Palmitic Acid Diet, Stearic Acid Test Meal and Oleic Acid Test Meal
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2026to Aug 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Florida State University
Tallahassee, Florida, 32306
Will Mumby, 850-644-1829, hnfs-cardionutritionlab@fsu.edu
About this study
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?
Read more
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.
- Conditions
- Healthy Middle-aged Subjects, Obesity & Overweight
- Being tested
- High Palmitic Acid Diet, Stearic Acid Test Meal, Oleic Acid Test Meal, High Stearic Acid Diet, High Oleic Acid Diet
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Palmitic Acid DietOther
On this intervention, participants will be given a diet rich in palmitic acid (~35% kcal/d palm stearin) for 14 days.
Stearic Acid Test MealOther
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 MealOther
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 DietOther
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 DietOther
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 MealOther
Participants will be given a test meal containing 50 g of stearic acid-rich (50g palm oil) fat.
| Study group | Role | What they receive |
|---|---|---|
| Stearic Acid | Experimental | Not described Receives: Other: High Palmitic Acid Diet; Other: Stearic Acid Test Meal; Other: High Stearic Acid Diet; Other: Palmitic Acid Test Meal |
| Oleic Acid | Active comparator | Not described Receives: Other: High Palmitic Acid Diet; Other: Oleic Acid Test Meal; Other: High Oleic Acid Diet; Other: Palmitic Acid Test Meal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postprandial Endothelial Function after a Stearic Acid vs Oleic Acid Test Meal
Brachial artery flow-mediated dilation (FMD) as measured in % dilation after a test meal
Measured: Day 1 of the stearic acid and oleic acid diets, after consuming the stearic acid or oleic acid test meals, respectively
Secondary outcomes (2)
Fasting Long-Term Changes Endothelial Function
Brachial artery flow-mediated dilation (FMD) as measured in % dilation
Measured: Fasting FMD measured on day 15 after the oleic acid and stearic acid diets
Postprandial Endothelial Function after Palmitic Acid Challenge Meal
Brachial artery flow-mediated dilation (FMD) as measured in % dilation
Measured: Day 15 after the high oleic acid and stearic acid diets, following the palmitic acid test meal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2026
- Study start1 Oct 2026 (estimated)
- Primary completionAug 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Middle-aged SubjectsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Florida State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Will Mumby, Florida State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07831603
- Sponsor's protocol ID
- STUDY00006972
- Status last verified
- Sep 2026
- First submitted
- 15 Sep 2026
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No