- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06361511
The Foods & Oil to Repair, Correct and Enhance Strength (FORCES) Study
April 11, 2024 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
Not yet recruiting
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Estimated)
66
Phase
- 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
- Name: Martha Belury, PhD RDN
- Phone Number: 614-292-1680
- Email: belury.1@osu.edu
Study Contact Backup
- Name: Rachel Cole
- Phone Number: 614-247-8235
- Email: belurylabstudies@osu.edu
Study Locations
-
-
Ohio
-
Columbus, Ohio, United States, 43210
- The Ohio State University
-
-
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
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 |
Intervention / Treatment |
---|---|
Experimental: High Linoleic Safflower Oil
consumption of 12g of high linoleic safflower oil every day
|
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
|
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
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
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
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
Collaborators
Investigators
- 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 (Estimated)
May 1, 2024
Primary Completion (Estimated)
May 1, 2029
Study Completion (Estimated)
May 1, 2030
Study Registration Dates
First Submitted
April 5, 2024
First Submitted That Met QC Criteria
April 11, 2024
First Posted (Actual)
April 12, 2024
Study Record Updates
Last Update Posted (Actual)
April 12, 2024
Last Update Submitted That Met QC Criteria
April 11, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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
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.
Clinical Trials on Sarcopenia
-
University of Texas at AustinNot yet recruitingExercise Training and SarcopeniaUnited States
-
Centre Hospitalier Universitaire DijonCompleted
-
Creighton UniversityUniversity of NebraskaRecruiting
-
University Hospital, CaenCompleted
-
University of NottinghamUniversity of OxfordRecruitingMuscle Atrophy | Age-Related SarcopeniaUnited Kingdom
-
Tufts UniversityNational Institute on Aging (NIA)CompletedMuscle Loss | Age-Related SarcopeniaUnited States
-
China Medical University HospitalCompleted
-
King's College LondonCo-sponsor: Guy's and St Thomas' NHS Foundation TrustCompletedFrailty | Sarcopenia | Age-Related SarcopeniaUnited Kingdom
-
Norwegian School of Sport SciencesOslo University HospitalNot yet recruitingHealthy Aging | Testosterone Deficiency | Age-Related Sarcopenia
-
Ningbo Medical Center Lihuili HospitalCompletedHemodialysis Patients With SarcopeniaChina
Clinical Trials on High Linoleic Acid Foods
-
Wake Forest University Health SciencesNational Center for Complementary and Integrative Health (NCCIH); University... and other collaboratorsCompletedFatty Acid-Gene InteractionsUnited States
-
Ohio State UniversityActive, not recruitingHealthy AdultsUnited States
-
Ohio State UniversityActive, not recruitingHealthy AdultsUnited States
-
University of TorontoCompleted
-
Ohio State UniversityNot yet recruitingInsomnia Type; Sleep Disorder
-
University of ChesterCompletedInflammation | Obesity | Lipid Disorder | Lung FunctionsUnited Kingdom
-
University College CorkRecruiting
-
Ohio State UniversityCorr-Jensen, LLC provided some of the study oil from Arista Industries, IncCompleted
-
University of JenaCognis Deutschland GmbH & Co. KGCompleted
-
Monsanto Company, LLCSolae, LLCCompletedHealthy Volunteers | Markers of Cardiovascular RiskUnited States