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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

Interested in This Trial?

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Conditions

Cardiovascular Diseases

Locations

The Pennylvania State University

University Park, Pennsylvania 16802

United States