Effects of Healthy Diets with Plant Oils on Heart and Metabolic Health
The Effects of Healthy Diets With Plant Oils on Heart and Metabolic Health: A Randomized, Crossover, Controlled-feeding Study
This study tests if a healthy diet with cottonseed oil can improve heart and metabolic health better than diets with other plant oils for people at risk of heart disease.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 52 (estimated) |
| Ages | 25 Years to 60 Years |
| Sex | All |
| Sponsor | Penn State University Academic / other |
| Locations | 1 site (University Park, Pennsylvania) |
| Trial ID | NCT06216678 on ClinicalTrials.gov |
What this trial studies
This study examines how a healthy diet that includes cottonseed oil impacts heart and metabolic health compared to diets with other plant oils. It is a randomized crossover feeding study that will assess changes in lipids and other risk factors for cardiometabolic diseases over a 4-week period. Participants will follow three different dietary patterns to determine which is most effective in improving health markers.
Who should consider this trial
Good fit: Ideal candidates are adults with elevated LDL cholesterol levels, a BMI between 25-40, and no significant metabolic disorders.
Not a fit: Patients with diabetes, significant cardiovascular history, or those on specific medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to dietary recommendations that significantly improve heart and metabolic health for individuals at risk.
How similar studies have performed: Previous studies have shown promising results with dietary interventions focusing on plant oils, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
University Park, Pennsylvania
- The Pennylvania State University — University Park, Pennsylvania, United States (Recruiting)
Study contacts
- Study coordinator: Kristina Petersen, PhD
- Email: kup63@psu.edu
- Phone: 814-865-7206
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.