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

The Ohio State University

Status: Begins enrollment this month

Conditions: Sarcopenia

Treatments: Other: High Linoleic Acid Foods; Other: High Oleic Acid Foods

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06361511

2023H0284

Details and patient eligibility

About

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.

Full 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

Enrollment: 66 estimated patients

Sex: All

Ages: 65 to 80 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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66 participants in 2 patient groups, including a placebo group

High Linoleic Safflower Oil

Experimental group

Description:

consumption of 12g of high linoleic safflower oil every day

Treatment:

Other: High Linoleic Acid Foods

High Oleic Safflower Oil

Placebo Comparator group

Description:

Consumption of 12g of high oleic safflower oil every day

Treatment:

Other: High Oleic Acid Foods