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The research study is an intervention and feasibility crossover design pilot study designed to assess if consuming 3 study foods made with either soybean oil or palm oil per day for 4 weeks can alter whole blood, plasma and erythrocyte fatty acids and body weight in overweight/obese adults. Additionally, the study will assess the adherence to consuming 3 study foods per day for 4 weeks and to assess if participant remain unaware of (or masked to) which study food group (soybean oil vs palm oil) they are consuming.
The objectives of the study include
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Soybean Oil | Experimental | Consumption of study foods each day made with soybean oil |
|
| Palm Oil | Placebo Comparator | Consumption of study foods each day made with palm oil |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Soybean Oil Foods | Other | Three food product containing 10g of soybean oil each will be consumed each day for a today of 30g of soybean oil consumed each day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in blood fatty acid composition | Determine changes in whole blood, plasma and erythrocyte linoleic acid in the soybean oil arm and determine the changes in whole blood, plasma and erythrocyte oleic acid and palmitic acid in the palm oil arm. Fatty acids for all sample types are reported as percent of total identified | Week 0, Week 2, Week 4, Week 6, Week 8, Week 10 |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in body weight | Determine changes in body weight in the soybean oil and palm oil arms | Week 0, Week 2, Week 4, Week 6, Week 8, Week 10 |
| Evidence of unmasking | Determine if there is evidence of unmasking of the two food product groups (soybean oil or palm oil) during the study in participants and in study coordinators using a questionnaire and calculating the Bang Blinding Index scale ranging from -1 to 1 with -1 is opposite guessing, 1 is lack of blinding and 0 is blinding |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Ohio State University Human Nutrition Laboratory | Columbus | Ohio | 43210 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41695083 | Derived | Yang CT, Cole RM, Colombo E, Angelotti A, Ni A, Belury MA. Foods Fortified with Soybean or Palm Oil Show No Effect on Inflammation or Oxidized Low-Density Lipoprotein in Adults with Overweight or Obesity: a Secondary Analysis of a Randomized Placebo-Controlled Crossover Trial. Curr Dev Nutr. 2026 Jan 7;10(2):107635. doi: 10.1016/j.cdnut.2025.107635. eCollection 2026 Feb. | |
| 41461275 |
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| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| Palm Oil Foods | Other | Three food product containing 10g of palm oil each will be consumed each day for a today of 30g of palm oil consumed each day |
|
| Week 4 and Week 10 |
| Adherence to study food consumption | Determine adherence of consuming 3 food products per day made with either soybean or palm oil through self report and returning of uneaten foods | Week 2, Week 4, Week 8, Week 10 |
| Derived |
| Cole RM, Colombo E, Angelotti A, Sparagna GC, Choriego RE, Jimenez-Flores R, Ni A, Belury MA. Feasibility Study of Soybean Oil-Fortified Foods to Alter Blood Content of Linoleic Acid and Body Weight: A Randomized Double-Masked Placebo-Controlled Crossover Trial. J Nutr. 2026 Feb;156(2):101288. doi: 10.1016/j.tjnut.2025.101288. Epub 2025 Dec 27. |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |