Clinical trial NCT06361511: The Foods & Oil to Repair, Correct and Enhance Strength (FORCES) 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Sarcopenia
Lead sponsor: Ohio State University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2024-04-12
Enrollment: 66
Sex: ALL
Minimum age (years): 65
Maximum age (years): 80
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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)

Primary outcomes:
measure: Changes is leg extensor muscle strength
timeFrame: Week 0 and Week 24
Secondary outcomes:
measure: Changes in quadriceps muscle volume
timeFrame: Week 0 and Week 24
measure: Change in maximum leg press strength
timeFrame: Week 0 and Week 24
measure: Change in leg fatiguability
timeFrame: Week 0 and Week 24
measure: Change in muscle mitochondria function
timeFrame: Week 0 and Week 24
measure: Changes in cardiolipin species
timeFrame: Week 0 and Week 24
measure: Changes in grip strength
timeFrame: Week 0 and Week 24
measure: Changes in gait speed
timeFrame: Week 0 and Week 24
measure: Changes in chair rise time
timeFrame: Week 0 and Week 24
measure: Changes in stair climb power
timeFrame: Week 0 and Week 24
measure: Change in short physical performance battery score
timeFrame: Week 0 and Week 24
measure: change in blood fatty acids
timeFrame: Week 0 and Week 24
Other outcomes:
measure: Association of changes in plasma linoleic acid with muscle function
timeFrame: Week 0 and Week 24
measure: Association of changes in plasma linoleic acid with muscle strength
timeFrame: Week 0 and Week 24
measure: Association of changes in plasma linoleic acid with muscle volume
timeFrame: Week 0 and Week 24
measure: Association of changes 4-LA-cardiolipin with muscle function
timeFrame: Week 0 and Week 24
measure: Association of changes 4-LA-cardiolipin with muscle strength
timeFrame: Week 0 and Week 24
measure: Association of changes 4-LA-cardiolipin with muscle volume
timeFrame: Week 0 and Week 24
measure: Association of changes mitochondria function with muscle volume.
timeFrame: Week 0 and Week 24
measure: Association of changes mitochondria function with muscle function
timeFrame: Week 0 and Week 24
measure: Association of changes mitochondria function with muscle strength.
timeFrame: Week 0 and Week 24
Locations:
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
Study officials:
affiliation: Ohio State University
name: Martha Belury, PhD RDN
role: PRINCIPAL_INVESTIGATOR
References: