Dietary Oils to Sustain Energy Study

Study Overview
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Brief Summary
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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.

Detailed Description
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The objectives of the study include To determine changes in whole blood, plasma and erythrocyte linoleic acid after 4 weeks of consuming 3 foods products made soybean oil and determine changes in plasma and erythrocyte oleic acid and palmitic acid after 4 weeks of consuming 3 food products per day made with palm oil in overweight/obese adults To determine changes in body weight in overweight/obese adults during four weeks of consuming 3 food products per day made with soybean oil and during four weeks of consuming 3 food products per day made with palm oil To 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 To determine adherence of consuming 3 food products per day made with either soybean or palm oil for 4 weeks in overweight/obese adults

Official Title
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Dietary Oils to Sustain Energy (DOSE) Study: Understanding How Consumption of Dietary Oils in Foods Influences Blood Fatty Acids and Body Weight

Conditions
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Overweight and Obesity

Intervention / Treatment
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* Other: Soybean Oil Foods
* Other: Palm Oil Foods


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 25-80 years old Nonsmokers BMI 25-55 kg/m2 Exclusion Criteria: Current or previous diagnosis of heart, kidney, and some liver diseases Current or previous diagnosis some circulatory diseases and some autoimmune diseases Treatment of current cancer diagnosis or current cancer diagnosis Current or previous diagnosis of diabetes Gastrointestinal diseases or disorders (including pancreatic) that influence nutrient digestion and absorption or gastric bypass surgery Alcohol or drug abuse Inability to access veins for venipuncture Hypothyroidism or Hyperthyroidism diagnosis Food Allergy or intolerances Any dietary restriction where consumption of the study foods or any ingredient would be contraindicated Use of medications where consuming the study foods would be contraindicated Use of supplements or medications for weight loss or following a weight loss program Use of supplements high in linoleic acid in the past 4 weeks prior to enrolling Pregnancy and lactation

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Soybean Oil<br>Consumption of study foods each day made with soybean oil | Other: Soybean Oil Foods<br>* 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<br>|
| Placebo Comparator: Palm Oil<br>Consumption of study foods each day made with palm oil | Other: Palm Oil Foods<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |