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

NCT ID: NCT06361511

Last Updated: 2025-05-29

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-01
• Study Completion Date: 2030-05-01

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

Conditions

Sarcopenia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

High Linoleic Safflower Oil

consumption of 12g of high linoleic safflower oil every day

Group Type: EXPERIMENTAL

High Linoleic Acid Foods

Intervention Type: 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 Safflower Oil

Consumption of 12g of high oleic safflower oil every day

Group Type: PLACEBO_COMPARATOR

High Oleic Acid Foods

Intervention Type: OTHER

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

Interventions

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

Intervention Type: OTHER

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

Intervention Type: OTHER

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)

• Minimum Eligible Age: 65 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

Ohio State University

OTHER

Sponsor Role: lead

Responsible Party

Martha Belury

Professor and Chair, Food Science and Technology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Martha Belury, PhD RDN

Role: PRINCIPAL_INVESTIGATOR

Ohio State University

Locations

The Ohio State University

Columbus, Ohio, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Martha Belury, PhD RDN

Role: CONTACT

belury.1@osu.edu

614-292-1680

Rachel Cole

Role: CONTACT

belurylabstudies@osu.edu

614-247-8235

Facility Contacts

Martha Belury, PhD

Role: primary

belury.1@osu.edu

614-292-1680

Other Identifiers

2023H0284

Identifier Type: -

Identifier Source: org_study_id