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Recruiting NCT06361511

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

No phase Interventional Sarcopenia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: High Linoleic Acid Foods, High Oleic Acid Foods.
Who it may be relevant to
Registry conditions: Sarcopenia. Basic parameters: 65 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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

Interventions

  • 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
  • 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

Primary outcome measures

  • Changes is leg extensor muscle strength [Time frame: Week 0 and Week 24]
Secondary outcome measures (11)
  • Changes in quadriceps muscle volume [Time frame: Week 0 and Week 24]
  • Change in maximum leg press strength [Time frame: Week 0 and Week 24]
  • Change in leg fatiguability [Time frame: Week 0 and Week 24]
  • Change in muscle mitochondria function [Time frame: Week 0 and Week 24]
  • Changes in cardiolipin species [Time frame: Week 0 and Week 24]
  • Changes in grip strength [Time frame: Week 0 and Week 24]
  • Changes in gait speed [Time frame: Week 0 and Week 24]
  • Changes in chair rise time [Time frame: Week 0 and Week 24]
  • Changes in stair climb power [Time frame: Week 0 and Week 24]
  • Change in short physical performance battery score [Time frame: Week 0 and Week 24]
  • change in blood fatty acids [Time frame: Week 0 and Week 24]

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • The Ohio State University — Columbus

Identifiers

NCT: NCT06361511 · 2023H0284

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗