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

Sarcopenia Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06361511
• Other study ID #: 2023H0284
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 1, 2024
• Est. completion date: May 1, 2030

Study information

• Verified date: April 2024
• Source: Ohio State University
• Contact: Martha Belury, PhD RDN
• Phone: 614-292-1680
• Email: belury.1[@]osu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 66
• Est. completion date: May 1, 2030
• Est. primary completion date: May 1, 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Sarcopenia

Intervention

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
• 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

Locations

Country	Name	City	State
United States	The Ohio State University	Columbus	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Ohio State University	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Association of changes in plasma linoleic acid with muscle function	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
Other	Association of changes in plasma linoleic acid with muscle strength	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
Other	Association of changes in plasma linoleic acid with muscle volume	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
Other	Association of changes 4-LA-cardiolipin with muscle function	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
Other	Association of changes 4-LA-cardiolipin with muscle strength	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
Other	Association of changes 4-LA-cardiolipin with muscle volume	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
Other	Association of changes mitochondria function with muscle volume.	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
Other	Association of changes mitochondria function with muscle function	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
Other	Association of changes mitochondria function with muscle strength.	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
Primary	Changes is leg extensor muscle strength	To determine the impact of high linoleic safflower oil on isokinetic leg extensor muscle strength through isokinetic dynamometer	Week 0 and Week 24
Secondary	Changes in quadriceps muscle volume	To determine the impact of high linoleic safflower oil on quadriceps muscle volume through MRI	Week 0 and Week 24
Secondary	Change in maximum leg press strength	To determine the impact of high linoleic safflower oil on maximum leg press strength using leg press machine	Week 0 and Week 24
Secondary	Change in leg fatiguability	To determine the impact of high linoleic safflower oil on muscle fatiguability through isokinetic dynamometer	Week 0 and Week 24
Secondary	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	Week 0 and Week 24
Secondary	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.	Week 0 and Week 24
Secondary	Changes in grip strength	To determine the impact of high linoleic safflower oil on grip strength measured using hand dynamometer.	Week 0 and Week 24
Secondary	Changes in gait speed	To determine the impact of high linoleic safflower oil on gait speed measured by timing a 400-meter walk.	Week 0 and Week 24
Secondary	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.	Week 0 and Week 24
Secondary	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	Week 0 and Week 24
Secondary	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)	Week 0 and Week 24
Secondary	change in blood fatty acids	To determine the impact of high linoleic safflower oil on changes in blood fatty acids using gas chromatography	Week 0 and Week 24