SarcopeniaNCT06361511
The Foods & Oil to Repair, Correct and Enhance Strength (FORCES) Study
A study testing High Linoleic Acid Foods and High Oleic Acid Foods in people with Sarcopenia, run by Ohio State University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 65 to 80 years
- Conditions the study is for
- Sarcopenia
- What is being tested?
- High Linoleic Acid Foods and High Oleic Acid Foods
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Apr 2025to 1 May 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 80 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Linoleic Acid Intake <75% of the adequate intake
- Probable sarcopenia
Who cannot join
- 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
Show all 18Show fewer
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The Ohio State University
Columbus, Ohio, 43210
Martha Belury, PhD, 614-292-1680, belury.1@osu.edu
About this study
Official title: 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.
Read the detailed description
Study Objectives
- To assess the effect of linoleic acid supplementation on muscle strength, muscle volume, fatigue- resistance, and physical mobility.
- To quantify the impact of linoleic acid supplementation on cardiolipin species and mitochondrial function in skeletal muscle of older adults
- Conditions
- Sarcopenia
- Being tested
- High Linoleic Acid Foods, High Oleic Acid Foods
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Linoleic Acid FoodsOther
Two food products containing 6g of high linoleic safflower oil each will be consumed each day for a total of 12g daily
High Oleic Acid FoodsOther
Two food products containing 6g of high oleic safflower oil each will be consumed each day for a total of 12g daily
| Study group | Role | What they receive |
|---|---|---|
| High Linoleic Safflower Oil | Experimental | consumption of 12g of high linoleic safflower oil every day Receives: Other: High Linoleic Acid Foods |
| High Oleic Safflower Oil | Placebo comparator | Consumption of 12g of high oleic safflower oil every day Receives: Other: High Oleic Acid Foods |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes is leg extensor muscle strength
To determine the impact of high linoleic safflower oil on isokinetic leg extensor muscle strength through isokinetic dynamometer
Measured: Week 0 and Week 24
Secondary outcomes (11)
Changes in quadriceps muscle volume
To determine the impact of high linoleic safflower oil on quadriceps muscle volume through MRI
Measured: Week 0 and Week 24
Change in maximum leg press strength
To determine the impact of high linoleic safflower oil on maximum leg press strength using leg press machine
Measured: Week 0 and Week 24
Change in leg fatiguability
To determine the impact of high linoleic safflower oil on muscle fatiguability through isokinetic dynamometer
Measured: Week 0 and Week 24
Change in muscle mitochondria function
To determine the impact of high linoleic safflower oil on muscle and peripheral blood mononuclear cell mitochondria oxygen consumption rate using the Oroboros instrument
Measured: Week 0 and Week 24
Changes in cardiolipin species
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.
Measured: Week 0 and Week 24
Changes in grip strength
To determine the impact of high linoleic safflower oil on grip strength measured using hand dynamometer.
Measured: Week 0 and Week 24
Changes in gait speed
To determine the impact of high linoleic safflower oil on gait speed measured by timing a 400-meter walk.
Measured: Week 0 and Week 24
Changes in chair rise time
To determine the impact of high linoleic safflower oil on chair rise time measured by timing rise from a seated position five times.
Measured: Week 0 and Week 24
Changes in stair climb power
To determine the impact of high linoleic safflower oil on stair climb time measured by timing the completion of climbing 1 flight of stairs
Measured: Week 0 and Week 24
Change in short physical performance battery score
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)
Measured: Week 0 and Week 24
change in blood fatty acids
To determine the impact of high linoleic safflower oil on changes in blood fatty acids using gas chromatography
Measured: Week 0 and Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2024
- Study start16 Apr 2025
- Primary completion1 May 2029 (estimated)
- Study completion1 May 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Principal investigator, Martha Belury, Ohio State University
- Investigators
- Martha Belury, PhD RDN, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06361511
- Sponsor's protocol ID
- 2023H0284
- Status last verified
- Apr 2026
- First submitted
- 5 Apr 2024
- Last updated
- 21 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Foods & Oil to Repair, Correct and Enhance Strength (FORCES) Study: Determining the Effect of Dietary Oils on Muscle Function, Strength and Mass
- ClinicalTrials.gov ID
- NCT06361511
- Acronym / sponsor ID
- 2023H0284
- Conditions
- Sarcopenia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- 16 Apr 2025 (actual)
- Primary completion
- 1 May 2029 (estimated)
- Study completion
- 1 May 2030 (estimated)
- First posted
- 12 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Study Objectives
- To assess the effect of linoleic acid supplementation on muscle strength, muscle volume, fatigue- resistance, and physical mobility.
- To quantify the impact of linoleic acid supplementation on cardiolipin species and mitochondrial function in skeletal muscle of older adults
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High Linoleic Safflower Oil | Experimental | Other: High Linoleic Acid Foodsconsumption of 12g of high linoleic safflower oil every day |
| High Oleic Safflower Oil | Placebo comparator | Other: High Oleic Acid FoodsConsumption of 12g of high oleic safflower oil every day |
Who may qualify
- Ages
- 65 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Linoleic Acid Intake <75% of the adequate intake
- Probable sarcopenia
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High Linoleic Acid FoodsTwo food products containing 6g of high linoleic safflower oil each will be consumed each day for a total of 12g daily | Other | High Linoleic Safflower Oil |
| High Oleic Acid FoodsTwo food products containing 6g of high oleic safflower oil each will be consumed each day for a total of 12g daily | Other | High Oleic Safflower Oil |
Primary outcome
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
11 secondary outcomes
Changes in quadriceps muscle volume
Time frame: Week 0 and Week 24
Change in maximum leg press strength
Time frame: Week 0 and Week 24
Change in leg fatiguability
Time frame: Week 0 and Week 24
Change in muscle mitochondria function
Time frame: Week 0 and Week 24
Changes in cardiolipin species
Time frame: Week 0 and Week 24
Changes in grip strength
Time frame: Week 0 and Week 24
Changes in gait speed
Time frame: Week 0 and Week 24
Changes in chair rise time
Time frame: Week 0 and Week 24
Changes in stair climb power
Time frame: Week 0 and Week 24
Change in short physical performance battery score
Time frame: Week 0 and Week 24
change in blood fatty acids
Time frame: Week 0 and Week 24
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Martha Belury, PhD RDN principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Linoleic Acid Foods and High Oleic Acid Foods in people with Sarcopenia, run by Ohio State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Martha Belury, PhD RDN (614-292-1680, belury.1@osu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes is leg extensor muscle strength (time frame: Week 0 and Week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2026.