Cardiovascular DiseasesNCT06216678
The Effects of Healthy Diets With Plant Oils on Heart and Metabolic Health
A study testing Healthy Dietary Pattern with Cottonseed Oil, Healthy Dietary Pattern with Fatty Acid-Matched Plant Oils and Healthy Dietary Pattern with PUFA:SFA Ratio-Matched Plant Oil in people with Cardiovascular Diseases, run by Penn State University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 25 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- Healthy Dietary Pattern with Cottonseed Oil, Healthy Dietary Pattern with Fatty Acid-Matched Plant Oils and Healthy Dietary Pattern with PUFA:SFA Ratio-Matched Plant Oil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Sep 2024to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 17Show fewer
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The Pennylvania State University
University Park, Pennsylvania, 16802
1-866-778-3438, DCHLab@psu.edu
About this study
Official title: The Effects of Healthy Diets With Plant Oils on Heart and Metabolic Health: A Randomized, Crossover, Controlled-feeding Study
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.
Read the 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
- Conditions
- Cardiovascular Diseases
- Being tested
- 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
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Healthy Dietary Pattern with Cottonseed OilOther
Cottonseed Oil
Healthy Dietary Pattern with Fatty Acid-Matched Plant OilsOther
Plant oil blend fatty acid matched
Healthy Dietary Pattern with PUFA:SFA Ratio-Matched Plant OilOther
Plant oil with matched PUFA to SFA ratio
| Study group | Role | What they receive |
|---|---|---|
| Healthy Diet + Cottonseed Oil (CSOD) | Experimental | Healthy dietary pattern containing 40g/day/2000 kcal of cottonseed oil (CSO) Receives: 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 Receives: 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. Receives: Other: Healthy Dietary Pattern with PUFA:SFA Ratio-Matched Plant Oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 weeks
Secondary outcomes (12)
Triglycerides concentration
Assessed from fasting blood draw expressed in mg/dL
Measured: 4 weeks
Total Cholesterol concentration
Assessed from fasting blood draw expressed in mg/dL
Measured: 4 weeks
HDL-cholesterol concentration
Assessed from fasting blood draw expressed in mg/dL
Measured: 4 weeks
Particle Size and Number of LDL, HDL, VLDL and Chylomicrons
Measured via Nuclear Magnetic Resonance
Measured: 4 weeks
Central Systolic and Diastolic Blood Pressure
Blood pressure measured assessed using a SphymoCor Xcel (Atcor Medical)
Measured: 4 weeks
Brachial Systolic and Diastolic Blood Pressure
Blood pressure measured assessed using a SphymoCor Xcel (Atcor Medical)
Measured: 4 weeks
Carotid-Femoral Pulse Wave Velocity
A measure of arterial stiffness assessed using a SphymoCor Xcel (Atcor Medical).
Expressed in meters/second.
Measured: 4 weeks
Fasting Serum Insulin concentration
Serum insulin levels assessed in a fasting blood draw and expressed in micro IU/mL
Measured: 4 weeks
Fasting Plasma Glucose concentration
Glucose assessed in a fasting blood draw and expressed in mg/dL
Measured: 4 weeks
Fasting Serum Fructosamine concentration
Fructosamine assessed in a fasting blood draw and expressed in micro IU/mL
Measured: 4 weeks
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
Measured: 4 weeks
Dihydrosterculic acid
Dihydrosterculic acid assessed from fasting blood draw and measured using Gas-Chromatography-Mass Spectrometry
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2024
- Study start9 Sep 2024
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by Penn State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Penn State University
- Sponsor type
- University, hospital or other
- Collaborators
- Cotton Incorporated
- Responsible party
- Principal investigator, Kristina Petersen PhD, APD, FAHA, Penn State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06216678
- Sponsor's protocol ID
- POS
- Status last verified
- Jan 2026
- First submitted
- 11 Jan 2024
- Last updated
- 2 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data will be deposited into an open access repository once results from all pre-specified primary and secondary outcomes are published.
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Healthy Diets With Plant Oils on Heart and Metabolic Health: A Randomized, Crossover, Controlled-feeding Study
- ClinicalTrials.gov ID
- NCT06216678
- Acronym / sponsor ID
- POS
- Conditions
- Cardiovascular Diseases
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Penn State UniversityUniversity, hospital or other
- Collaborators
- Cotton Incorporated
- Study start
- 9 Sep 2024 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 22 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy Diet + Cottonseed Oil (CSOD) | Experimental | Other: Healthy Dietary Pattern with Cottonseed OilHealthy dietary pattern containing 40g/day/2000 kcal of cottonseed oil (CSO) |
| Healthy Diet + Fatty Acid-Matched Plant Oils (FAMD) | Active comparator | Other: Healthy Dietary Pattern with Fatty Acid-Matched Plant OilsHealthy 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 |
| Healthy Diet + PUFA:SFA Ratio-Matched Plant Oil (P:S-MD) | Active comparator | Other: Healthy Dietary Pattern with PUFA:SFA Ratio-Matched Plant OilHealthy 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. |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (17 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Healthy Dietary Pattern with Cottonseed OilCottonseed Oil | Other | Healthy Diet + Cottonseed Oil (CSOD) |
| Healthy Dietary Pattern with Fatty Acid-Matched Plant OilsPlant oil blend fatty acid matched | Other | Healthy Diet + Fatty Acid-Matched Plant Oils (FAMD) |
| Healthy Dietary Pattern with PUFA:SFA Ratio-Matched Plant OilPlant oil with matched PUFA to SFA ratio | Other | Healthy Diet + PUFA:SFA Ratio-Matched Plant Oil (P:S-MD) |
Primary outcome
LDL-cholesterol concentration
Time frame: 4 weeks
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.
12 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data will be deposited into an open access repository once results from all pre-specified primary and secondary outcomes are published.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Healthy Dietary Pattern with Cottonseed Oil, Healthy Dietary Pattern with Fatty Acid-Matched Plant Oils and Healthy Dietary Pattern with PUFA:SFA Ratio-Matched Plant Oil in people with Cardiovascular Diseases, run by Penn State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kristina Petersen, PhD (814-865-7206, kup63@psu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
LDL-cholesterol concentration (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2026.