Dietary Oils to Sustain Energy Study (DOSE)

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Overweight and Obesity
• Intervention / Treatment: Other: Soybean Oil Foods; Other: Palm Oil Foods

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

• Study Type: Interventional
• Enrollment (Estimated): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • The Ohio State University Human Nutrition Laboratory

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Soybean Oil; Consumption of study foods each day made with soybean oil	Other: Soybean Oil Foods; 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
Placebo Comparator: Palm Oil; Consumption of study foods each day made with palm oil	Other: Palm Oil Foods; 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Ohio State University

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 19, 2021
• Primary Completion (Actual): July 30, 2025
• Study Completion (Estimated): December 30, 2026

Study Registration Dates

• First Submitted: July 15, 2021
• First Submitted That Met QC Criteria: July 15, 2021
• First Posted (Actual): July 23, 2021

Study Record Updates

• Last Update Posted (Actual): April 21, 2026
• Last Update Submitted That Met QC Criteria: April 16, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Overweight; Obesity
• Other Study ID Numbers: 2021H0232

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No