Stearic Acid and Endothelial Function
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.
Studieoversigt
Status
Betingelser
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Florida
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Tallahassee, Florida, Forenede Stater, 32306
- Florida State University
-
Kontakt:
- Will Mumby
- Telefonnummer: 850-644-1829
- E-mail: hnfs-cardionutritionlab@fsu.edu
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-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Grundvidenskab
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Tredobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Stearic Acid
|
On this intervention, participants will be given a diet rich in palmitic acid (~35% kcal/d palm stearin) for 14 days. Participants will be given a test meal containing 50 g of stearic acid-rich (~90/~10% cocoa butter / high-linoleic sunflower oil) fat. 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. Participants will be given a test meal containing 50 g of stearic acid-rich (50g palm oil) fat. |
|
Aktiv komparator: Oleic Acid
|
On this intervention, participants will be given a diet rich in palmitic acid (~35% kcal/d palm stearin) for 14 days. Participants will be given a test meal containing 50 g of stearic acid-rich (50g palm oil) fat. Participants will be given a test meal with 50 g of oleic acid-rich (~55/~45% palm olein / high-oleic sunflower oil) fat. 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. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Postprandial Endothelial Function after a Stearic Acid vs Oleic Acid Test Meal
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Fasting Long-Term Changes Endothelial Function
Tidsramme: 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
Tidsramme: 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
|
Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- STUDY00006972
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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