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Recruiting

NCT Number: NCT06361511

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

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.

Recruiting

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Key information

Age range

65 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Ohio State University

Columbus, Ohio, 43210, United States

Location status: Recruiting

Location contact

Martha Belury, PhD

CONTACT

[email protected]

614-292-1680

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

High Linoleic Acid Foods

Other

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

Other

Two food products containing 6g of high oleic safflower oil each will be consumed each day for a total of 12g daily

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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

  10. 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)

  11. 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

Other outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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.

  6. 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

  7. 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

  8. 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.

  9. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Martha Belury, PhD RDN

CONTACT

[email protected]

614-292-1680

Rachel Cole

CONTACT

[email protected]

614-247-8235

Sponsors and collaborators

Lead sponsor

Ohio State University

Other

Collaborators

  • National Institutes of Health (NIH)

Registry information

Official study title

The Foods & Oil to Repair, Correct and Enhance Strength (FORCES) Study: Determining the Effect of Dietary Oils on Muscle Function, Strength and Mass

Important dates

Study start
2025
Primary completion
2029
Study completion
2030
First posted
Apr 12, 2024
Registry last updated
Apr 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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