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

NCT06361511 | Recruiting

• 1 other identifier: 2023H0284
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Sarcopenia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Changes in quadriceps muscle volume

  Week 0 and Week 24

• Change in maximum leg press strength

  Week 0 and Week 24

• Change in leg fatiguability

  Week 0 and Week 24

• Change in muscle mitochondria function

  Week 0 and Week 24

• Changes in cardiolipin species

  Week 0 and Week 24

Other Outcomes (9)

• Association of changes in plasma linoleic acid with muscle function

  Week 0 and Week 24

• Association of changes in plasma linoleic acid with muscle strength

  Week 0 and Week 24

• Association of changes in plasma linoleic acid with muscle volume

  Week 0 and Week 24

Study Arms (2)

High Linoleic Safflower Oil

EXPERIMENTAL

consumption of 12g of high linoleic safflower oil every day

Other: High Linoleic Acid Foods

High Oleic Safflower Oil

PLACEBO COMPARATOR

Consumption of 12g of high oleic safflower oil every day

Other: High Oleic Acid Foods

Interventions

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 Linoleic Safflower Oil

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

High Oleic Safflower Oil

Eligibility Criteria

• Age: 65 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Linoleic Acid Intake \<75% of the adequate intake
• Probable sarcopenia

You may not qualify if:

• 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

Sponsors & Collaborators

• Ohio State University: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

The Ohio State University

Columbus, Ohio, 43210, United States

RECRUITING

MeSH Terms

Conditions

Sarcopenia

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Officials

• Martha Belury, PhD RDN

  Ohio State University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Martha Belury, PhD RDN

CONTACT

614-292-1680; belury.1@osu.edu

Rachel Cole

CONTACT

614-247-8235; belurylabstudies@osu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chair, Food Science and Technology

Study Record Dates

• First Submitted: April 5, 2024
• First Posted: April 12, 2024
• Study Start: April 16, 2025
• Primary Completion (Estimated): May 1, 2029
• Study Completion (Estimated): May 1, 2030
• Last Updated: April 21, 2026

Record last verified: 2026-04

Locations

US (1)