RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2025-02-03

Study Completion:2030-05-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06361511

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:65 Years to 80 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Linoleic Acid Intake \<75% of the adequate intake * Probable sarcopenia	* 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)

Inclusion Criteria

Exclusion Criteria

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

* 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)

Contacts and Locations

Study Contact

Martha Belury, PhD RDN

CONTACT

614-292-1680

belury.1@osu.edu

Rachel Cole

CONTACT

614-247-8235

belurylabstudies@osu.edu

Principal Investigator

Martha Belury, PhD RDN

PRINCIPAL_INVESTIGATOR

Ohio State University

Study Locations (Sites)

The Ohio State University

Columbus, Ohio, 43210

United States

Collaborators and Investigators

Sponsor: Ohio State University

Martha Belury, PhD RDN, PRINCIPAL_INVESTIGATOR, Ohio State University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-02-03

Study Completion Date2030-05-01

Study Record Updates

Study Start Date2025-02-03

Study Completion Date2030-05-01

Terms related to this study

Additional Relevant MeSH Terms

Sarcopenia