Clinical trial NCT06216678: The Effects of Healthy Diets With Plant Oils on Heart and Metabolic Health
Official title: The Effects of Healthy Diets With Plant Oils on Heart and Metabolic Health: A Randomized, Crossover, Controlled-feeding Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cardiovascular Diseases
Lead sponsor: Penn State University
Sponsor class: OTHER
Collaborators: name: Cotton Incorporated
First posted: 2024-01-22
Enrollment: 52
Sex: ALL
Minimum age (years): 25
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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 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: 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

Primary outcomes:
measure: LDL-cholesterol concentration
timeFrame: 4 weeks
Secondary outcomes:
measure: Triglycerides concentration
timeFrame: 4 weeks
measure: Total Cholesterol concentration
timeFrame: 4 weeks
measure: HDL-cholesterol concentration
timeFrame: 4 weeks
measure: Particle Size and Number of LDL, HDL, VLDL and Chylomicrons
timeFrame: 4 weeks
measure: Central Systolic and Diastolic Blood Pressure
timeFrame: 4 weeks
measure: Brachial Systolic and Diastolic Blood Pressure
timeFrame: 4 weeks
measure: Carotid-Femoral Pulse Wave Velocity
timeFrame: 4 weeks
measure: Fasting Serum Insulin concentration
timeFrame: 4 weeks
measure: Fasting Plasma Glucose concentration
timeFrame: 4 weeks
measure: Fasting Serum Fructosamine concentration
timeFrame: 4 weeks
measure: Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)
timeFrame: 4 weeks
measure: Dihydrosterculic acid
timeFrame: 4 weeks
Other outcomes:
measure: Composition of the Gut Microbiota
timeFrame: 4 weeks
measure: Fatty acids
timeFrame: 4 weeks
Locations:
city: University Park
country: United States
facility: The Pennylvania State University
state: Pennsylvania
Study officials:
References: