NCT06361511招募中不适用
The Foods & Oil to Repair, Correct and Enhance Strength (FORCES) Study: Determining the Effect of Dietary Oils on Muscle Function, Strength and Mass
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Changes is leg extensor muscle strength
研究概览
简要总结
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.
详细描述
Study Objectives
- To assess the effect of linoleic acid supplementation on muscle strength, muscle volume, fatigue- resistance, and physical mobility.
- To quantify the impact of linoleic acid supplementation on cardiolipin species and mitochondrial function in skeletal muscle of older adults
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 80 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Linoleic Acid Intake <75% of the adequate intake
- •Probable sarcopenia
排除标准
- •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)
研究组 & 干预措施
High Linoleic Safflower Oil
Experimental
consumption of 12g of high linoleic safflower oil every day
干预措施: High Linoleic Acid Foods (Other)
High Oleic Safflower Oil
Placebo Comparator
Consumption of 12g of high oleic safflower oil every day
干预措施: High Oleic Acid Foods (Other)
结局指标
主要结局
Changes is leg extensor muscle strength
时间窗: Week 0 and Week 24
To determine the impact of high linoleic safflower oil on isokinetic leg extensor muscle strength through isokinetic dynamometer
次要结局
- Changes in gait speed(Week 0 and Week 24)
- Change in leg fatiguability(Week 0 and Week 24)
- Changes in cardiolipin species(Week 0 and Week 24)
- Changes in grip strength(Week 0 and Week 24)
- Changes in chair rise time(Week 0 and Week 24)
- Changes in stair climb power(Week 0 and Week 24)
- Changes in quadriceps muscle volume(Week 0 and Week 24)
- Change in maximum leg press strength(Week 0 and Week 24)
- change in blood fatty acids(Week 0 and Week 24)
- Change in muscle mitochondria function(Week 0 and Week 24)
- Change in short physical performance battery score(Week 0 and Week 24)
研究者
Martha Belury
Professor and Chair, Food Science and Technology
Ohio State University
研究点 (1)
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