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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stearic Acid and Endothelial Function
- ClinicalTrials.gov ID
- NCT07831603
- Acronym / sponsor ID
- STUDY00006972
- Conditions
- Healthy Middle-aged Subjects, Obesity & Overweight
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Florida State UniversityUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 21 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stearic Acid | Experimental | Other: High Palmitic Acid Diet, Other: Stearic Acid Test Meal, Other: High Stearic Acid Diet, Other: Palmitic Acid Test Meal |
| Oleic Acid | Active comparator | Other: High Palmitic Acid Diet, Other: Oleic Acid Test Meal, Other: High Oleic Acid Diet, Other: Palmitic Acid Test Meal |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (12 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High Palmitic Acid DietOn this intervention, participants will be given a diet rich in palmitic acid (~35% kcal/d palm stearin) for 14 days. | Other | Oleic Acid, Stearic Acid |
| Stearic Acid Test MealParticipants will be given a test meal containing 50 g of stearic acid-rich (~90/~10% cocoa butter / high-linoleic sunflower oil) fat. | Other | Stearic Acid |
| Oleic Acid Test MealParticipants will be given a test meal with 50 g of oleic acid-rich (~55/~45% palm olein / high-oleic sunflower oil) fat. | Other | Oleic Acid |
| High Stearic Acid DietParticipants 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 | Stearic Acid |
| High Oleic Acid DietParticipants will be given a high oleic acid-rich (~35% kcal/d ~55/~45% palm olein / high-oleic sunflower oil mixture) for 14 days total. | Other | Oleic Acid |
| Palmitic Acid Test MealParticipants will be given a test meal containing 50 g of stearic acid-rich (50g palm oil) fat. | Other | Oleic Acid, Stearic Acid |
Primary outcome
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
2 secondary outcomes
Fasting Long-Term Changes Endothelial Function
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.