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

Cardiovascular Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06216678
• Other study ID #: POS
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 2024
• Est. completion date: December 2025

Study information

• Verified date: April 2024
• Source: Penn State University
• Contact: Kristina Petersen, PhD
• Phone: 814-865-7206
• Email: kup63[@]psu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 52
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Diseases

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Penn State University	Cotton Incorporated

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Composition of the Gut Microbiota	Abundance measured using 16 s rRNA sequencing	4 weeks
Other	Fatty acids	Fatty acid analysis of red blood cells assessed from fasting blood draw and measured using Gas Chromatography	4 weeks
Primary	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.	4 weeks
Secondary	Triglycerides concentration	Assessed from fasting blood draw expressed in mg/dL	4 weeks
Secondary	Total Cholesterol concentration	Assessed from fasting blood draw expressed in mg/dL	4 weeks
Secondary	HDL-cholesterol concentration	Assessed from fasting blood draw expressed in mg/dL	4 weeks
Secondary	Particle Size and Number of LDL, HDL, VLDL and Chylomicrons	Measured via Nuclear Magnetic Resonance	4 weeks
Secondary	Central Systolic and Diastolic Blood Pressure	Blood pressure measured assessed using a SphymoCor Xcel (Atcor Medical)	4 weeks
Secondary	Brachial Systolic and Diastolic Blood Pressure	Blood pressure measured assessed using a SphymoCor Xcel (Atcor Medical)	4 weeks
Secondary	Carotid-Femoral Pulse Wave Velocity	A measure of arterial stiffness assessed using a SphymoCor Xcel (Atcor Medical).; Expressed in meters/second.	4 weeks
Secondary	Fasting Serum Insulin concentration	Serum insulin levels assessed in a fasting blood draw and expressed in micro IU/mL	4 weeks
Secondary	Fasting Plasma Glucose concentration	Glucose assessed in a fasting blood draw and expressed in mg/dL	4 weeks
Secondary	Fasting Serum Fructosamine concentration	Fructosamine assessed in a fasting blood draw and expressed in micro IU/mL	4 weeks
Secondary	Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)	Calculated from insulin and glucose measured from a fasting blood sample. Calculated as (insulin × glucose) / 22.5	4 weeks
Secondary	Dihydrosterculic acid	Dihydrosterculic acid assessed from fasting blood draw and measured using Gas-Chromatography-Mass Spectrometry	4 weeks