Clinical trial NCT04975763: Dietary Oils to Sustain Energy Study
Official title: Dietary Oils to Sustain Energy (DOSE) Study: Understanding How Consumption of Dietary Oils in Foods Influences Blood Fatty Acids and Body Weight
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Overweight and Obesity
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2021-07-23
Enrollment: 16
Sex: ALL
Minimum age (years): 25
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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: 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

Eligibility criteria: 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

Primary outcomes:
measure: Changes in blood fatty acid composition
timeFrame: Week 0, Week 2, Week 4, Week 6, Week 8, Week 10
Secondary outcomes:
measure: Changes in body weight
timeFrame: Week 0, Week 2, Week 4, Week 6, Week 8, Week 10
measure: Evidence of unmasking
timeFrame: Week 4 and Week 10
measure: Adherence to study food consumption
timeFrame: Week 2, Week 4, Week 8, Week 10
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University Human Nutrition Laboratory
state: Ohio
Study officials:
References: