The Effects of Healthy Diets With Plant Oils on Heart and Metabolic Health: A Randomized, Crossover, Controlled-feeding Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Penn State University
- Enrollment
- 52
- Locations
- 1
- Primary Endpoint
- LDL-cholesterol concentration
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Prevention
- Masking
- Double (Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 25 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Healthy Diet + Cottonseed Oil (CSOD)
Healthy dietary pattern containing 40g/day/2000 kcal of cottonseed oil (CSO)
Intervention: Healthy Dietary Pattern with Cottonseed Oil (Other)
Healthy Diet + Fatty Acid-Matched Plant Oils (FAMD)
Healthy dietary pattern containing 40g/day/2000 kcal of a blend of plant oils comprising a fatty acid profile that matches the CSOD but devoid of CSO
Intervention: Healthy Dietary Pattern with Fatty Acid-Matched Plant Oils (Other)
Healthy Diet + PUFA:SFA Ratio-Matched Plant Oil (P:S-MD)
Healthy dietary pattern containing 40g/day/2000 kcal of plant oil that is lower in polyunsaturated fatty acids (PUFA) and saturated fatty acids (SFA) than the CSOD, but with a matched PUFA:SFA ratio and devoid of CSO.
Intervention: Healthy Dietary Pattern with PUFA:SFA Ratio-Matched Plant Oil (Other)
Outcomes
Primary Outcomes
LDL-cholesterol concentration
Time Frame: 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 Outcomes
- HDL-cholesterol concentration(4 weeks)
- Particle Size and Number of LDL, HDL, VLDL and Chylomicrons(4 weeks)
- Brachial Systolic and Diastolic Blood Pressure(4 weeks)
- Fasting Serum Insulin concentration(4 weeks)
- Fasting Plasma Glucose concentration(4 weeks)
- Triglycerides concentration(4 weeks)
- Fasting Serum Fructosamine concentration(4 weeks)
- Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)(4 weeks)
- Dihydrosterculic acid(4 weeks)
- Total Cholesterol concentration(4 weeks)
- Central Systolic and Diastolic Blood Pressure(4 weeks)
- Carotid-Femoral Pulse Wave Velocity(4 weeks)
Investigators
Kristina Petersen PhD, APD, FAHA
Associate Professor
Penn State University