Dietary Oils to Sustain Energy Study

NCT ID: NCT04975763

Last Updated: 2025-08-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-19

Study Completion Date

2025-12-30

Brief Summary

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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

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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

Conditions

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Overweight and Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Soybean Oil

Consumption of study foods each day made with soybean oil

Group Type EXPERIMENTAL

Soybean Oil Foods

Intervention Type 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

Palm Oil

Consumption of study foods each day made with palm oil

Group Type PLACEBO_COMPARATOR

Palm Oil Foods

Intervention Type 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

Interventions

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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

Intervention Type 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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

25 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ohio State University

OTHER

Sponsor Role lead

Responsible Party

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Martha Belury

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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The Ohio State University Human Nutrition Laboratory

Columbus, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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2021H0232

Identifier Type: -

Identifier Source: org_study_id

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