Health TrialsbyHealthPanel

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

ConditionCardiovascular Diseases
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age25-60
SponsorPenn State University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Crossover

Treatments tested in this trial

  • Healthy Dietary Pattern with Cottonseed Oil

    Other intervention

    Cottonseed Oil

  • Healthy Dietary Pattern with Fatty Acid-Matched Plant Oils

    Other intervention

    Plant oil blend fatty acid matched

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

    Other intervention

    Plant oil with matched PUFA to SFA ratio

Treatment groups

52 Participants
are divided into 3 treatment groups
Group A: Healthy Diet + Cottonseed Oil (CSOD)Experimental treatment 1 intervention
Group B: Healthy Diet + Fatty Acid-Matched Plant Oils (FAMD)Active comparator 1 intervention
Group C: Healthy Diet + PUFA:SFA Ratio-Matched Plant Oil (P:S-MD)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

LDL-cholesterol concentration

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.

Time frame
4 weeks

Secondary outcomes

1

Triglycerides concentration

Assessed from fasting blood draw expressed in mg/dL

Time frame
4 weeks
2

Total Cholesterol concentration

Assessed from fasting blood draw expressed in mg/dL

Time frame
4 weeks
3

HDL-cholesterol concentration

Assessed from fasting blood draw expressed in mg/dL

Time frame
4 weeks
4

Particle Size and Number of LDL, HDL, VLDL and Chylomicrons

Measured via Nuclear Magnetic Resonance

Time frame
4 weeks

Other outcomes

1

Composition of the Gut Microbiota

Abundance measured using 16 s rRNA sequencing

Time frame
4 weeks
2

Fatty acids

Fatty acid analysis of red blood cells assessed from fasting blood draw and measured using Gas Chromatography

Time frame
4 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Penn State University

Lead sponsor

Cotton Incorporated

Collaborator

Source ClinicalTrials.gov
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