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

NCT06216678 | Recruiting

• 1 other identifier: POS
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Diseases

Outcome Measures

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.

  4 weeks

Secondary Outcomes (12)

• Triglycerides concentration

  4 weeks

• Total Cholesterol concentration

  4 weeks

• HDL-cholesterol concentration

  4 weeks

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

  4 weeks

• Central Systolic and Diastolic Blood Pressure

  4 weeks

Other Outcomes (2)

• Composition of the Gut Microbiota

  4 weeks

• Fatty acids

  4 weeks

Study Arms (3)

Healthy Diet + Cottonseed Oil (CSOD)

EXPERIMENTAL

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

Other: Healthy Dietary Pattern with Cottonseed Oil

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

ACTIVE COMPARATOR

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

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

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

ACTIVE COMPARATOR

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.

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

Interventions

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

Plant oil with matched PUFA to SFA ratio

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

Healthy Dietary Pattern with Cottonseed Oil OTHER

Cottonseed Oil

Healthy Diet + Cottonseed Oil (CSOD)

Healthy Dietary Pattern with Fatty Acid-Matched Plant Oils OTHER

Plant oil blend fatty acid matched

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

Eligibility Criteria

• Age: 25 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cotton Incorporated: collaborator
• Penn State University: lead

Study Sites (1)

The Pennylvania State University

University Park, Pennsylvania, 16802, United States

RECRUITING

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

Cottonseed Oil

Intervention Hierarchy (Ancestors)

Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fats, Unsaturated; Plant Oils; Oils; Plant Preparations; Biological Products; Complex Mixtures; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Central Study Contacts

Kristina Petersen, PhD

CONTACT

814-865-7206; kup63@psu.edu

Stacey Meily

CONTACT

814-863-8622; sas117@psu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 11, 2024
• First Posted: January 22, 2024
• Study Start: September 9, 2024
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: February 2, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: After publication of all pre-specified primary and secondary outcomes

Locations

US (1)