The Effects of Healthy Diets With Plant Oils on Heart and Metabolic Health
NCT ID: NCT06216678
Last Updated: 2024-10-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
52 participants
INTERVENTIONAL
2024-09-09
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
PREVENTION
DOUBLE
Study Groups
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Healthy Diet + Cottonseed Oil (CSOD)
Healthy dietary pattern containing 40g/day/2000 kcal of cottonseed oil (CSO)
Healthy Dietary Pattern with Cottonseed Oil
Cottonseed Oil
Healthy Diet + Fatty Acid-Matched Plant Oils (FAMD)
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
Healthy Dietary Pattern with Fatty Acid-Matched Plant Oils
Plant oil blend fatty acid matched
Healthy Diet + PUFA:SFA Ratio-Matched Plant Oil (P:S-MD)
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.
Healthy Dietary Pattern with PUFA:SFA Ratio-Matched Plant Oil
Plant oil with matched PUFA to SFA ratio
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
25 Years
60 Years
ALL
Yes
Sponsors
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Cotton Incorporated
UNKNOWN
Penn State University
OTHER
Responsible Party
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Kristina Petersen PhD, APD, FAHA
Associate Professor
Locations
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The Pennylvania State University
University Park, Pennsylvania, United States
Countries
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Central Contacts
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Facility Contacts
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Role: primary
Provided Documents
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Document Type: Statistical Analysis Plan
Other Identifiers
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POS
Identifier Type: -
Identifier Source: org_study_id
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