Recruiting

Cottonseed Oil

Sponsor:

Penn State University

Code:

NCT06216678

Conditions

Cardiovascular Diseases

Eligibility Criteria

Sex: All

Age: 25 - 60

Healthy Volunteers: Accepted

Interventions

Healthy Dietary Pattern with Cottonseed Oil

Healthy Dietary Pattern with Fatty Acid-Matched Plant Oils

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

Study Details

Brief summary:

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.

Conditions

Cardiovascular Diseases

Study ID

NCT06216678

Start date

Sep 9, 2024

Status verified date

Jan, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 25 - 60

Healthy Volunteers: Accepted

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

Study Design

Enrollment

52 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Healthy Diet + Cottonseed Oil (CSOD)

Healthy dietary pattern containing 40g/day/2000 kcal of cottonseed oil (CSO)

active comparator: Healthy Diet + Fatty Acid-Matched Plant Oils (FAMD)

Healthy dietary pattern containing 40g/day/2000 kcal of a blend of plant oils comprising a fatty acid profile that matches the CSOD but devoid of CSO

active comparator: Healthy Diet + PUFA:SFA Ratio-Matched Plant Oil (P:S-MD)

Healthy dietary pattern containing 40g/day/2000 kcal of plant oil that is lower in polyunsaturated fatty acids (PUFA) and saturated fatty acids (SFA) than the CSOD, but with a matched PUFA:SFA ratio and devoid of CSO.

Interventions

Healthy Dietary Pattern with Cottonseed Oil

Cottonseed Oil

Healthy Dietary Pattern with Fatty Acid-Matched Plant Oils

Plant oil blend fatty acid matched

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

Plant oil with matched PUFA to SFA ratio

Primary outcome measure

  • LDL-cholesterol concentration [ Time Frame: 4 weeks ]

Central Contacts and Locations

Central contacts

Kristina Petersen, PhD

814-865-7206kup63@psu.edu

Stacey Meily

814-863-8622sas117@psu.edu

Locations

The Pennylvania State University

Recruiting

University Park, Pennsylvania, United States, 16802

Contacts

1-866-778-3438DCHLab@psu.edu

More Information

Sponsor

Penn State University

Last update posted

Feb 2, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Penn State University on 2026-02-02.