NCT06216678NARecruitingAccepts Healthy Volunteers
The Effects of Healthy Diets With Plant Oils on Heart and Metabolic Health
Penn State University
Start Date
9/9/2024
Completion Date
12/1/2027
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.
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
Eligibility Criteria
Age Range: 25 years to 60 years
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
Interventions
OTHER
Healthy Dietary Pattern with Cottonseed Oil
OTHER
Healthy Dietary Pattern with Fatty Acid-Matched Plant Oils
OTHER
Healthy Dietary Pattern with PUFA:SFA Ratio-Matched Plant Oil
Conditions
Cardiovascular Diseases
Locations
The Pennylvania State University
University Park, Pennsylvania 16802
United States