Status:
RECRUITING
The Effects of Healthy Diets With Plant Oils on Heart and Metabolic Health
Lead Sponsor:
Penn State University
Collaborating Sponsors:
Cotton Incorporated
Conditions:
Cardiovascular Diseases
Eligibility:
All Genders
25-60 years
Phase:
NA
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...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 9 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT06216678
Start Date
September 9 2024
End Date
December 1 2025
Last Update
October 9 2024
Active Locations (1)
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1
The Pennylvania State University
University Park, Pennsylvania, United States, 16802