The Foods & Oil to Repair, Correct and Enhance Strength (FORCES) Study
- Conditions
- Sarcopenia
- Interventions
- Other: High Oleic Acid FoodsOther: High Linoleic Acid Foods
- Registration Number
- NCT06361511
- Lead Sponsor
- Ohio State University
- Brief 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.
- 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
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 66
- Linoleic Acid Intake <75% of the adequate intake
- Probable sarcopenia
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description High Oleic Safflower Oil High Oleic Acid Foods Consumption of 12g of high oleic safflower oil every day High Linoleic Safflower Oil High Linoleic Acid Foods consumption of 12g of high linoleic safflower oil every day
- Primary Outcome Measures
Name Time Method Changes is leg extensor muscle strength Week 0 and Week 24 To determine the impact of high linoleic safflower oil on isokinetic leg extensor muscle strength through isokinetic dynamometer
- Secondary Outcome Measures
Name Time Method Change in leg fatiguability Week 0 and Week 24 To determine the impact of high linoleic safflower oil on muscle fatiguability through isokinetic dynamometer
Changes in cardiolipin species 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.
Changes in grip strength Week 0 and Week 24 To determine the impact of high linoleic safflower oil on grip strength measured using hand dynamometer.
Changes in chair rise time 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.
Changes in stair climb power 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
Changes in quadriceps muscle volume Week 0 and Week 24 To determine the impact of high linoleic safflower oil on quadriceps muscle volume through MRI
Change in maximum leg press strength Week 0 and Week 24 To determine the impact of high linoleic safflower oil on maximum leg press strength using leg press machine
change in blood fatty acids Week 0 and Week 24 To determine the impact of high linoleic safflower oil on changes in blood fatty acids using gas chromatography
Change in muscle mitochondria function 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
Changes in gait speed Week 0 and Week 24 To determine the impact of high linoleic safflower oil on gait speed measured by timing a 400-meter walk.
Change in short physical performance battery score 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)
Trial Locations
- Locations (1)
The Ohio State University
🇺🇸Columbus, Ohio, United States