Dietary Oils to Sustain Energy Study (DOSE)
Primary Purpose
Overweight and Obesity
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Soybean Oil Foods
Palm Oil Foods
Sponsored by
About this trial
This is an interventional treatment trial for Overweight and Obesity
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
Sites / Locations
- The Ohio State University Human Nutrition Laboratory
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Soybean Oil
Palm Oil
Arm Description
Consumption of study foods each day made with soybean oil
Consumption of study foods each day made with palm oil
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Changes in body weight
Determine changes in body weight in the soybean oil and palm oil arms
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
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04975763
Brief Title
Dietary Oils to Sustain Energy Study
Acronym
DOSE
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
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 19, 2021 (Actual)
Primary Completion Date
December 30, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ohio State University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight and Obesity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
16 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Soybean Oil
Arm Type
Experimental
Arm Description
Consumption of study foods each day made with soybean oil
Arm Title
Palm Oil
Arm Type
Placebo Comparator
Arm Description
Consumption of study foods each day made with palm oil
Intervention Type
Other
Intervention Name(s)
Soybean Oil Foods
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Palm Oil Foods
Intervention Description
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
Primary Outcome Measure Information:
Title
Changes in blood fatty acid composition
Description
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
Time Frame
Week 0, Week 2, Week 4, Week 6, Week 8, Week 10
Secondary Outcome Measure Information:
Title
Changes in body weight
Description
Determine changes in body weight in the soybean oil and palm oil arms
Time Frame
Week 0, Week 2, Week 4, Week 6, Week 8, Week 10
Title
Evidence of unmasking
Description
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
Time Frame
Week 4 and Week 10
Title
Adherence to study food consumption
Description
Determine adherence of consuming 3 food products per day made with either soybean or palm oil through self report and returning of uneaten foods
Time Frame
Week 2, Week 4, Week 8, Week 10
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
The Ohio State University Human Nutrition Laboratory
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Dietary Oils to Sustain Energy Study
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