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NCT Number: NCT06216678

The Effects of Healthy Diets With Plant Oils on Heart and Metabolic Health

This study will examine the effect of a healthy diet containing cottonseed oil compared to healthy diets containing other commonly consumed plant oils on biomarkers of heart and metabolic health after 4 weeks.

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Key information

Age range

25 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Pennylvania State University

University Park, Pennsylvania, 16802, United States

Location status: Recruiting

Location contact

About this study

This is a 3-period randomized crossover complete feeding study examining if a dietary pattern containing cottonseed oil improves lipids/lipoproteins and other cardiometabolic disease risk factors to a greater extent than a fatty acid matched diet devoid of cottonseed oil and a diet lower in polyunsaturated fatty acids (PUFA) and saturated fatty acids (SFA), but with a matched PUFA:SFA ratio

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • LDL-C ≥100 mg/dL and ≤190 mg/dL
  • BMI of 25-40 kg/m2
  • Blood pressure <140/90 mmHg
  • Fasting blood glucose <126 mg/dL
  • Fasting triglycerides <350 mg/dL
  • ≤10% change in body weight for 6 months prior to enrollment

Exclusion criteria

  • Type 1 or type 2 diabetes or fasting blood glucose ≥126 mg/dL
  • Prescription of anti-hypertensive, lipid lowering or glucose lowering drugs
  • Intake of supplements that affect the outcomes of interest and unwilling to cease during the study period
  • Diagnosed liver, kidney, or autoimmune disease
  • Prior cardiovascular event (e.g., stroke, heart attack)
  • Current pregnancy or intention of pregnancy within the next 6 months
  • Lactation within prior 6 months
  • Follows a vegetarian or vegan diet
  • Food allergies/intolerance/sensitives/dislikes of foods included in the study menu
  • Antibiotic use within the prior 1 month
  • Oral steroid use within the prior 1 month
  • Use of tobacco or nicotine containing products with in the past 6 months
  • Cancer any site within the past 10 years (eligible if ≥10 years without recurrence) or non-melanoma skin cancer with in the past 5 years (eligible if ≥5 years without recurrence)
  • Participation in another clinical trial within 30 days of baseline
  • Currently following a restricted or weight loss diet
  • Prior bariatric surgery
  • Intake of >14 alcoholic drinks/week and/or lack of willingness to consume a maximum of two standard drinks per week while enrolled in the study and/or not willing to avoid alcohol consumption for 48 hour prior to test visits

Treatment and study plan

Healthy Dietary Pattern with Cottonseed Oil

Other

Cottonseed Oil

Healthy Dietary Pattern with Fatty Acid-Matched Plant Oils

Other

Plant oil blend fatty acid matched

Healthy Dietary Pattern with PUFA:SFA Ratio-Matched Plant Oil

Other

Plant oil with matched PUFA to SFA ratio

Primary outcomes

  1. LDL-cholesterol concentration

    Time frame: 4 weeks

    Assessed from fasting blood draw expressed in mg/dL. LDL-cholesterol will be measured directly via enzymatic assay. The mean of the LDL-cholesterol values from day 1 and day 2 testing will be used for analysis.

Secondary outcomes

  1. Triglycerides concentration

    Time frame: 4 weeks

    Assessed from fasting blood draw expressed in mg/dL

  2. Total Cholesterol concentration

    Time frame: 4 weeks

    Assessed from fasting blood draw expressed in mg/dL

  3. HDL-cholesterol concentration

    Time frame: 4 weeks

    Assessed from fasting blood draw expressed in mg/dL

  4. Particle Size and Number of LDL, HDL, VLDL and Chylomicrons

    Time frame: 4 weeks

    Measured via Nuclear Magnetic Resonance

  5. Central Systolic and Diastolic Blood Pressure

    Time frame: 4 weeks

    Blood pressure measured assessed using a SphymoCor Xcel (Atcor Medical)

  6. Brachial Systolic and Diastolic Blood Pressure

    Time frame: 4 weeks

    Blood pressure measured assessed using a SphymoCor Xcel (Atcor Medical)

  7. Carotid-Femoral Pulse Wave Velocity

    Time frame: 4 weeks

    A measure of arterial stiffness assessed using a SphymoCor Xcel (Atcor Medical).

    Expressed in meters/second.

  8. Fasting Serum Insulin concentration

    Time frame: 4 weeks

    Serum insulin levels assessed in a fasting blood draw and expressed in micro IU/mL

  9. Fasting Plasma Glucose concentration

    Time frame: 4 weeks

    Glucose assessed in a fasting blood draw and expressed in mg/dL

  10. Fasting Serum Fructosamine concentration

    Time frame: 4 weeks

    Fructosamine assessed in a fasting blood draw and expressed in micro IU/mL

  11. Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)

    Time frame: 4 weeks

    Calculated from insulin and glucose measured from a fasting blood sample. Calculated as (insulin × glucose) / 22.5

  12. Dihydrosterculic acid

    Time frame: 4 weeks

    Dihydrosterculic acid assessed from fasting blood draw and measured using Gas-Chromatography-Mass Spectrometry

Other outcomes

  1. Composition of the Gut Microbiota

    Time frame: 4 weeks

    Abundance measured using 16 s rRNA sequencing

  2. Fatty acids

    Time frame: 4 weeks

    Fatty acid analysis of red blood cells assessed from fasting blood draw and measured using Gas Chromatography

Study contacts

Contact information is provided by the study sponsor or research team.

Kristina Petersen, PhD

CONTACT

[email protected]

814-865-7206

Stacey Meily

CONTACT

[email protected]

814-863-8622

Sponsors and collaborators

Lead sponsor

Penn State University

Other

Collaborators

  • Cotton Incorporated

Registry information

Official study title

The Effects of Healthy Diets With Plant Oils on Heart and Metabolic Health: A Randomized, Crossover, Controlled-feeding Study

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Jan 22, 2024
Registry last updated
Feb 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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