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| Name | Class |
|---|---|
| Cotton Incorporated | UNKNOWN |
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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy Diet + Cottonseed Oil (CSOD) | Experimental | Healthy dietary pattern containing 40g/day/2000 kcal of cottonseed oil (CSO) |
|
| 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 |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Healthy Dietary Pattern with Cottonseed Oil | Other | Cottonseed Oil |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Triglycerides concentration | Assessed from fasting blood draw expressed in mg/dL | 4 weeks |
| Total Cholesterol concentration | Assessed from fasting blood draw expressed in mg/dL |
| Measure | Description | Time Frame |
|---|---|---|
| Composition of the Gut Microbiota | Abundance measured using 16 s rRNA sequencing | 4 weeks |
| Fatty acids | Fatty acid analysis of red blood cells assessed from fasting blood draw and measured using Gas Chromatography |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kristina Petersen, PhD | Contact | 814-865-7206 | kup63@psu.edu | |
| Stacey Meily | Contact | 814-863-8622 | sas117@psu.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Pennylvania State University | Recruiting | University Park | Pennsylvania | 16802 | United States |
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.
After publication of all pre-specified primary and secondary outcomes
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 26, 2024 | Jul 26, 2024 |
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| Healthy Dietary Pattern with Fatty Acid-Matched Plant Oils |
| Other |
Plant oil blend fatty acid matched |
|
| Healthy Dietary Pattern with PUFA:SFA Ratio-Matched Plant Oil | Other | Plant oil with matched PUFA to SFA ratio |
|
| 4 weeks |
| HDL-cholesterol concentration | Assessed from fasting blood draw expressed in mg/dL | 4 weeks |
| Particle Size and Number of LDL, HDL, VLDL and Chylomicrons | Measured via Nuclear Magnetic Resonance | 4 weeks |
| Central Systolic and Diastolic Blood Pressure | Blood pressure measured assessed using a SphymoCor Xcel (Atcor Medical) | 4 weeks |
| Brachial Systolic and Diastolic Blood Pressure | Blood pressure measured assessed using a SphymoCor Xcel (Atcor Medical) | 4 weeks |
| Carotid-Femoral Pulse Wave Velocity | A measure of arterial stiffness assessed using a SphymoCor Xcel (Atcor Medical). Expressed in meters/second. | 4 weeks |
| Fasting Serum Insulin concentration | Serum insulin levels assessed in a fasting blood draw and expressed in micro IU/mL | 4 weeks |
| Fasting Plasma Glucose concentration | Glucose assessed in a fasting blood draw and expressed in mg/dL | 4 weeks |
| Fasting Serum Fructosamine concentration | Fructosamine assessed in a fasting blood draw and expressed in micro IU/mL | 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 | 4 weeks |
| Dihydrosterculic acid | Dihydrosterculic acid assessed from fasting blood draw and measured using Gas-Chromatography-Mass Spectrometry | 4 weeks |
| 4 weeks |
| SAP_001.pdf |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D003369 | Cottonseed Oil |
| ID | Term |
|---|---|
| D004042 | Dietary Fats, Unsaturated |
| D004041 | Dietary Fats |
| D005223 | Fats |
| D008055 | Lipids |
| D005224 | Fats, Unsaturated |
| D010938 | Plant Oils |
| D009821 | Oils |
| D028321 | Plant Preparations |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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