Stearic Acid for Vascular Function in Obesity

No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Are You a Good Fit for This Trial?

This trial is for men and women aged 40-70 who are overweight or obese, as well as healthy individuals in that age range. Participants should be able to follow a controlled diet and attend clinic visits. People with certain health conditions or dietary restrictions may not qualify.

Inclusion Criteria

BMI 25.0-40.0 kg/m2
Seated blood pressure <130/80 mmHg
Willing and able to attend laboratory visits
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Exclusion Criteria

Pregnant or lactating
Athlete
Significant change in bodyweight of ≥ 5% within the past 6 months
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks
1 visit (in-person)

Dietary Intervention

Participants consume a 14-day controlled diet high in palmitic acid, followed by a 14-day diet high in either stearic acid or oleic acid

28 days
2 visits (in-person, 5 hours each)

Postprandial Testing

Participants undergo vascular and blood assessments after consuming high-fat test meals

4 hours per visit
2 visits (in-person, 5 hours each)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

What Are the Treatments Tested in This Trial?

Trial Overview

The study compares the effects of diets and meals high in different fats—stearic acid, oleic acid, and palmitic acid—on blood vessel function. Participants eat specific test meals and follow assigned diets for two weeks, with regular blood tests and artery checks.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Stearic AcidExperimental Treatment4 Interventions
Group II: Oleic AcidActive Control4 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Florida State University

Lead Sponsor

Trials
234
Recruited
41,100+