The Effects of Healthy Diets With Plant Oils on Heart and Metabolic Health
Purpose
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.
Condition
- Cardiovascular Diseases
Eligibility
- Eligible Ages
- Between 25 Years and 60 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- Yes
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
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover Assignment
- Primary Purpose
- Prevention
- Masking
- Double (Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
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. |
|
Recruiting Locations
The Pennylvania State University
University Park, Pennsylvania 16802
University Park, Pennsylvania 16802
More Details
- NCT ID
- NCT06216678
- Status
- Recruiting
- Sponsor
- Penn State University
Detailed Description
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