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

The Pennsylvania State University (PENNSTATE)

Status: Enrolling

Conditions: Cardiovascular Diseases

Treatments: Other: Healthy Dietary Pattern with Fatty Acid-Matched Plant Oils; Other: Healthy Dietary Pattern with PUFA:SFA Ratio-Matched Plant Oil; Other: Healthy Dietary Pattern with Cottonseed Oil

Study type: Interventional

Funder types: Other

Identifiers

NCT06216678

POS

Details and patient eligibility

About

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.

Full 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

Enrollment: 52 estimated patients

Sex: All

Ages: 25 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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52 participants in 3 patient groups

Healthy Diet + Cottonseed Oil (CSOD)

Experimental group

Description:

Healthy dietary pattern containing 40g/day/2000 kcal of cottonseed oil (CSO)

Treatment:

Other: Healthy Dietary Pattern with Cottonseed Oil

Healthy Diet + Fatty Acid-Matched Plant Oils (FAMD)

Active Comparator group

Description:

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

Treatment:

Other: Healthy Dietary Pattern with Fatty Acid-Matched Plant Oils

Healthy Diet + PUFA:SFA Ratio-Matched Plant Oil (P:S-MD)

Active Comparator group

Description:

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.

Treatment:

Other: Healthy Dietary Pattern with PUFA:SFA Ratio-Matched Plant Oil