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Stearic Acid and Endothelial Function

ConditionsHealthy Middle-aged SubjectsObesity & Overweight
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-70
SponsorFlorida State University

About 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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • High Palmitic Acid Diet

    Other intervention

    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 intervention

    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 intervention

    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 intervention

    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 intervention

    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 intervention

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

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Stearic AcidExperimental treatment 4 interventions
Group B: Oleic AcidActive comparator 4 interventions

Trial outcomes

Primary outcomes

1

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

Time frame
Day 1 of the stearic acid and oleic acid diets, after consuming the stearic acid or oleic acid test meals, respectively

Secondary outcomes

1

Fasting Long-Term Changes Endothelial Function

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

Time frame
Fasting FMD measured on day 15 after the oleic acid and stearic acid diets
2

Postprandial Endothelial Function after Palmitic Acid Challenge Meal

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

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Florida State University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: