The Foods & Oil to Repair, Correct and Enhance Strength (FORCES) Study

April 16, 2026 updated by: Martha Belury, Ohio State University

The Foods & Oil to Repair, Correct and Enhance Strength (FORCES) Study: Determining the Effect of Dietary Oils on Muscle Function, Strength and Mass

The proposed research is a parallel arm, randomized placebo-controlled clinical trial designed to assess changes in muscle strength, volume, fatigue resistance, and mobility in older adults after daily consumption of 12g of linoleic acid-rich oil.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Study Objectives

  1. To assess the effect of linoleic acid supplementation on muscle strength, muscle volume, fatigue- resistance, and physical mobility.
  2. To quantify the impact of linoleic acid supplementation on cardiolipin species and mitochondrial function in skeletal muscle of older adults

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
66

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Martha Belury, PhD RDN
  • Phone Number: 614-292-1680
  • Email: belury.1@osu.edu

Study Contact Backup

Study Locations

  • United States
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Recruiting
        • The Ohio State University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Linoleic Acid Intake <75% of the adequate intake
  • Probable sarcopenia

Exclusion Criteria:

  • Gastrointestinal diseases or disorders (including pancreatic and gastric bypass surgery) where consumption of the study foods would be contraindication or where the disease or disorder could negatively affect nutrient absorption and/or would prevent participants from tolerating the study foods
  • Hyperthyroidism diagnosis
  • Food Allergy or intolerances
  • Any dietary restriction where consumption of the study foods or any ingredient would be contraindicated
  • Unstable management of heart failure, heart disease events (including stroke or heart attack) within last 3 months prior to enrollment, a plan for heart surgeries or cardiac procedures
  • Current or previous diagnosis of severe kidney failure, liver cirrhosis, other liver diseases/infections that cause liver damage and some pulmonary diseases or severe/uncontrolled pulmonary diseases
  • Severe or uncontrolled rheumatologic or orthopedic diseases
  • Current diagnosis of or current treatment of cancer other than non-melanoma skin cancer
  • Neuromuscular or neurological conditions or diseases or use of mobility assistance (wheelchair, walker etc..) that would impact movement needed to perform the muscle function tests or prevent completion of the muscle function tests
  • Use of mobility assistance (wheelchair, walker etc..) that would prevent completion of the muscle function tests
  • Current 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
  • Alcohol or drug abuse
  • Allergy/intolerance to lidocaine or similar medication
  • Use of anticoagulant, antiplatelet, or other blood thinner medications
  • Terminal Illness
  • Any condition leading to muscle loss or weakness, impaired mobility or range of motion in legs (excluding normal aging)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: High Linoleic Safflower Oil
consumption of 12g of high linoleic safflower oil every day
Other: High Linoleic Acid Foods
Two food products containing 6g of high linoleic safflower oil each will be consumed each day for a total of 12g daily
Placebo Comparator: High Oleic Safflower Oil
Consumption of 12g of high oleic safflower oil every day
Other: High Oleic Acid Foods
Two food products containing 6g of high oleic safflower oil each will be consumed each day for a total of 12g daily

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Changes is leg extensor muscle strength
Time Frame: Week 0 and Week 24
To determine the impact of high linoleic safflower oil on isokinetic leg extensor muscle strength through isokinetic dynamometer
Week 0 and Week 24

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Changes in quadriceps muscle volume
Time Frame: Week 0 and Week 24
To determine the impact of high linoleic safflower oil on quadriceps muscle volume through MRI
Week 0 and Week 24
Change in maximum leg press strength
Time Frame: Week 0 and Week 24
To determine the impact of high linoleic safflower oil on maximum leg press strength using leg press machine
Week 0 and Week 24
Change in leg fatiguability
Time Frame: Week 0 and Week 24
To determine the impact of high linoleic safflower oil on muscle fatiguability through isokinetic dynamometer
Week 0 and Week 24
Change in muscle mitochondria function
Time Frame: Week 0 and Week 24
To determine the impact of high linoleic safflower oil on muscle and peripheral blood mononuclear cell mitochondria oxygen consumption rate using the Oroboros instrument
Week 0 and Week 24
Changes in cardiolipin species
Time Frame: Week 0 and Week 24
To determine the impact of high linoleic safflower oil on muscle and peripheral blood mononuclear cell cardiolipin species measured using electrospray ionization-mass spectrometry coupled to high-performance liquid chromatography.
Week 0 and Week 24
Changes in grip strength
Time Frame: Week 0 and Week 24
To determine the impact of high linoleic safflower oil on grip strength measured using hand dynamometer.
Week 0 and Week 24
Changes in gait speed
Time Frame: Week 0 and Week 24
To determine the impact of high linoleic safflower oil on gait speed measured by timing a 400-meter walk.
Week 0 and Week 24
Changes in chair rise time
Time Frame: Week 0 and Week 24
To determine the impact of high linoleic safflower oil on chair rise time measured by timing rise from a seated position five times.
Week 0 and Week 24
Changes in stair climb power
Time Frame: Week 0 and Week 24
To determine the impact of high linoleic safflower oil on stair climb time measured by timing the completion of climbing 1 flight of stairs
Week 0 and Week 24
Change in short physical performance battery score
Time Frame: Week 0 and Week 24
To determine the impact of high linoleic safflower oil on short physical performance battery short score which is calculated by measured by measuring time it takes to walk 4 meters, rise from a chair 5 times and the ability to balance in 3 standing positions for 10 seconds each. Scores range from 0 (predicts for worst physical performance) to 12 (predicts for best physical performance)
Week 0 and Week 24
change in blood fatty acids
Time Frame: Week 0 and Week 24
To determine the impact of high linoleic safflower oil on changes in blood fatty acids using gas chromatography
Week 0 and Week 24

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Association of changes in plasma linoleic acid with muscle function
Time Frame: Week 0 and Week 24
Use multiple linear regressions to determine the association of change in plasma linoleic acid with changes in leg extensor muscle strength
Week 0 and Week 24
Association of changes in plasma linoleic acid with muscle strength
Time Frame: Week 0 and Week 24
Use multiple linear regressions to determine the association of change in plasma linoleic acid with changes in maximum leg press strength
Week 0 and Week 24
Association of changes in plasma linoleic acid with muscle volume
Time Frame: Week 0 and Week 24
Use multiple linear regressions to determine the association of change in plasma linoleic acid with changes in muscle volume measured by MRI
Week 0 and Week 24
Association of changes 4-LA-cardiolipin with muscle function
Time Frame: Week 0 and Week 24
Use multiple linear regressions to determine the association of change in 4-LA-cardiolipin with changes in leg extensor muscle strength
Week 0 and Week 24
Association of changes 4-LA-cardiolipin with muscle strength
Time Frame: Week 0 and Week 24
Use multiple linear regressions to determine the association of change in 4-LA-cardiolipin with changes in maximum leg press strength.
Week 0 and Week 24
Association of changes 4-LA-cardiolipin with muscle volume
Time Frame: Week 0 and Week 24
Use multiple linear regressions to determine the association of change in 4-LA-cardiolipin with changes in leg muscle volume measured by MRI
Week 0 and Week 24
Association of changes mitochondria function with muscle volume.
Time Frame: Week 0 and Week 24
Use multiple linear regressions to determine the association of change in mitochondria function with changes in leg muscle volume measured by MRI
Week 0 and Week 24
Association of changes mitochondria function with muscle function
Time Frame: Week 0 and Week 24
Use multiple linear regressions to determine the association of change in mitochondria function with changes in leg extensor muscle strength.
Week 0 and Week 24
Association of changes mitochondria function with muscle strength.
Time Frame: Week 0 and Week 24
Use multiple linear regressions to determine the association of change in mitochondria function with changes in maximum leg press strength.
Week 0 and Week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ohio State University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institutes of Health (NIH)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Martha Belury, PhD RDN, Ohio State University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 16, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 5, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 11, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 12, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 21, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 16, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2023H0284

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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