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

Официальное название

The Foods & Oil to Repair, Correct and Enhance Strength (FORCES) Study: Determining the Effect of Dietary Oils on Muscle Function, Strength and Mass

Обзор

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.

Подробное описание

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

Вмешательства

• Другое 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
• Другое 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

Первичные конечные точки

• Changes is leg extensor muscle strength [Срок оценки: Week 0 and Week 24]

Вторичные конечные точки (11)

• Changes in quadriceps muscle volume [Срок оценки: Week 0 and Week 24]
• Change in maximum leg press strength [Срок оценки: Week 0 and Week 24]
• Change in leg fatiguability [Срок оценки: Week 0 and Week 24]
• Change in muscle mitochondria function [Срок оценки: Week 0 and Week 24]
• Changes in cardiolipin species [Срок оценки: Week 0 and Week 24]
• Changes in grip strength [Срок оценки: Week 0 and Week 24]
• Changes in gait speed [Срок оценки: Week 0 and Week 24]
• Changes in chair rise time [Срок оценки: Week 0 and Week 24]
• Changes in stair climb power [Срок оценки: Week 0 and Week 24]
• Change in short physical performance battery score [Срок оценки: Week 0 and Week 24]
• change in blood fatty acids [Срок оценки: Week 0 and Week 24]

Критерии участия

Критерии включения

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

Критерии исключения

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• The Ohio State University — Columbus

Идентификаторы

NCT: NCT06361511 · 2023H0284

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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