Dietary Oils to Sustain Energy Study

Not Applicable

Active, not recruiting

• Conditions: Overweight and Obesity
• Interventions: Other: Soybean Oil Foods; Other: Palm Oil Foods

• Registration Number: NCT04975763
• Lead Sponsor: Ohio State University

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

Study Timeline

• Study First Submitted: 2021-07-15
• Study First Submitted QC: 2021-07-15
• Study Start: 2021-07-19
• Study First Posted: 2021-07-23
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-27
• Last Update Posted: 2024-10-29
• Primary Completion: 2025-06-30
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 16

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Soybean Oil	Soybean Oil Foods	Consumption of study foods each day made with soybean oil
Palm Oil	Palm Oil Foods	Consumption of study foods each day made with palm oil

Primary Outcome Measures

Name	Time	Method
Changes in blood fatty acid composition	Week 0, Week 2, Week 4, Week 6, Week 8, Week 10	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

Name	Time	Method
Evidence of unmasking	Week 4 and Week 10	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
Changes in body weight	Week 0, Week 2, Week 4, Week 6, Week 8, Week 10	Determine changes in body weight in the soybean oil and palm oil arms
Adherence to study food consumption	Week 2, Week 4, Week 8, Week 10	Determine adherence of consuming 3 food products per day made with either soybean or palm oil through self report and returning of uneaten foods

Trial Locations

Locations (1)

The Ohio State University Human Nutrition Laboratory; 🇺🇸 Columbus, Ohio, United States