Dietary Oils to Sustain Energy Study

NCT04975763 | Active Not Recruiting

• 1 other identifier: 2021H0232
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Overweight and Obesity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Changes in body weight

  Week 0, Week 2, Week 4, Week 6, Week 8, Week 10

• Evidence of unmasking

  Week 4 and Week 10

• Adherence to study food consumption

  Week 2, Week 4, Week 8, Week 10

Study Arms (2)

Soybean Oil

EXPERIMENTAL

Consumption of study foods each day made with soybean oil

Other: Soybean Oil Foods

Palm Oil

PLACEBO COMPARATOR

Consumption of study foods each day made with palm oil

Other: Palm Oil Foods

Interventions

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

Soybean Oil

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

Palm Oil

Eligibility Criteria

• Age: 25 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 25-80 years old
• Nonsmokers
• BMI 25-55 kg/m2

You may not qualify if:

• 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

Sponsors & Collaborators

• Ohio State University: lead

Study Sites (1)

The Ohio State University Human Nutrition Laboratory

Columbus, Ohio, 43210, United States

Location

Related Publications (2)

• 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.

  PMID: 41695083 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.

  PMID: 41461275 DERIVED

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 15, 2021
• First Posted: July 23, 2021
• Study Start: July 19, 2021
• Primary Completion: July 30, 2025
• Study Completion (Estimated): December 30, 2026
• Last Updated: April 21, 2026

Record last verified: 2026-04

Locations

US (1)