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Recruiting NCT06216678

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

No phase Interventional Cardiovascular Diseases

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Healthy Dietary Pattern with Cottonseed Oil, Healthy Dietary Pattern with Fatty Acid-Matched Plant Oils, Healthy Dietary Pattern with PUFA:SFA Ratio-Matched Plant Oil.
Who it may be relevant to
Registry conditions: Cardiovascular Diseases. Basic parameters: 25 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

The Effects of Healthy Diets With Plant Oils on Heart and Metabolic Health: A Randomized, Crossover, Controlled-feeding Study

Overview

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

  • Other Healthy Dietary Pattern with Cottonseed Oil
    Cottonseed Oil
  • Other Healthy Dietary Pattern with Fatty Acid-Matched Plant Oils
    Plant oil blend fatty acid matched
  • Other Healthy Dietary Pattern with PUFA:SFA Ratio-Matched Plant Oil
    Plant oil with matched PUFA to SFA ratio

Primary outcome measures

  • LDL-cholesterol concentration [Time frame: 4 weeks]
Secondary outcome measures (12)
  • Triglycerides concentration [Time frame: 4 weeks]
  • Total Cholesterol concentration [Time frame: 4 weeks]
  • HDL-cholesterol concentration [Time frame: 4 weeks]
  • Particle Size and Number of LDL, HDL, VLDL and Chylomicrons [Time frame: 4 weeks]
  • Central Systolic and Diastolic Blood Pressure [Time frame: 4 weeks]
  • Brachial Systolic and Diastolic Blood Pressure [Time frame: 4 weeks]
  • Carotid-Femoral Pulse Wave Velocity [Time frame: 4 weeks]
  • Fasting Serum Insulin concentration [Time frame: 4 weeks]
  • Fasting Plasma Glucose concentration [Time frame: 4 weeks]
  • Fasting Serum Fructosamine concentration [Time frame: 4 weeks]
  • Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) [Time frame: 4 weeks]
  • Dihydrosterculic acid [Time frame: 4 weeks]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Crossover
Masking
Double blind
Primary purpose
Prevention

Study locations

United States · 1 center
  • The Pennylvania State University — University Park

Identifiers

NCT: NCT06216678 · POS

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗