The Effects of Healthy Diets With Plant Oils on Heart and Metabolic Health

Not Applicable

Recruiting

• Conditions: Cardiovascular Diseases

• Registration Number: NCT06216678
• Lead Sponsor: Penn State University

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

Study Timeline

• Study First Submitted: 2024-01-11
• Study First Submitted QC: 2024-01-11
• Study First Posted: 2024-01-22
• Study Start: 2024-09-09
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-08
• Last Update Posted: 2024-10-09
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 52

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
LDL-cholesterol concentration	4 weeks	Assessed from fasting blood draw expressed in mg/dL. LDL-cholesterol will be measured directly via enzymatic assay. The mean of the LDL-cholesterol values from day 1 and day 2 testing will be used for analysis.

Secondary Outcome Measures

Name	Time	Method
Brachial Systolic and Diastolic Blood Pressure	4 weeks	Blood pressure measured assessed using a SphymoCor Xcel (Atcor Medical)
Fasting Serum Insulin concentration	4 weeks	Serum insulin levels assessed in a fasting blood draw and expressed in micro IU/mL
HDL-cholesterol concentration	4 weeks	Assessed from fasting blood draw expressed in mg/dL
Particle Size and Number of LDL, HDL, VLDL and Chylomicrons	4 weeks	Measured via Nuclear Magnetic Resonance
Fasting Plasma Glucose concentration	4 weeks	Glucose assessed in a fasting blood draw and expressed in mg/dL
Triglycerides concentration	4 weeks	Assessed from fasting blood draw expressed in mg/dL
Fasting Serum Fructosamine concentration	4 weeks	Fructosamine assessed in a fasting blood draw and expressed in micro IU/mL
Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)	4 weeks	Calculated from insulin and glucose measured from a fasting blood sample. Calculated as (insulin × glucose) / 22.5
Dihydrosterculic acid	4 weeks	Dihydrosterculic acid assessed from fasting blood draw and measured using Gas-Chromatography-Mass Spectrometry
Total Cholesterol concentration	4 weeks	Assessed from fasting blood draw expressed in mg/dL
Central Systolic and Diastolic Blood Pressure	4 weeks	Blood pressure measured assessed using a SphymoCor Xcel (Atcor Medical)
Carotid-Femoral Pulse Wave Velocity	4 weeks	A measure of arterial stiffness assessed using a SphymoCor Xcel (Atcor Medical).; Expressed in meters/second.

Trial Locations

Locations (1)

The Pennylvania State University; 🇺🇸 University Park, Pennsylvania, United States