Cardiovascular Diseases
Conditions
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
Interventions
OTHERHealthy Dietary Pattern with Cottonseed Oil
Cottonseed Oil
OTHERHealthy Dietary Pattern with Fatty Acid-Matched Plant Oils
Plant oil blend fatty acid matched
OTHERHealthy Dietary Pattern with PUFA:SFA Ratio-Matched Plant Oil
Plant oil with matched PUFA to SFA ratio
Sponsors
Penn State University
Cotton Incorporated
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
25 Years to 60 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Triglycerides concentration | 4 weeks | Assessed from fasting blood draw expressed in mg/dL |
| Total Cholesterol concentration | 4 weeks | Assessed from fasting blood draw expressed in mg/dL |
| 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 |
| Central Systolic and Diastolic Blood Pressure | 4 weeks | Blood pressure measured assessed using a SphymoCor Xcel (Atcor Medical) |
| Brachial 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. |
| Fasting Serum Insulin concentration | 4 weeks | Serum insulin levels assessed in a fasting blood draw and expressed in micro IU/mL |
| Fasting Plasma Glucose concentration | 4 weeks | Glucose assessed in a fasting blood draw and 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 |
Countries
United States
Contacts
CONTACTKristina Petersen, PhD
CONTACTStacey Meily
Outcome results
None listed