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临床试验/NCT05862779
NCT05862779进行中(未招募)不适用

Effects of Omega-3 and Whey Protein Supplementation on Lean Mass and Strength Gains in Older Adults Performing Resistance Exercise: A Randomized, Double-Blind and Placebo-Controlled Study

Federal University of Uberlandia2 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2024年7月30日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
75
试验地点
2
主要终点
Changes in lean mass (kg) using ultrasound and dual-energy X-ray absorptiometry (DXA) in postmenopausal women

研究概览

简要总结

To evaluate the effect of omega-3 supplementation combined with whey protein intake on lean mass, muscle strength, metabolomic and lipidomic profiles, and biomarkers of oxidative stress and inflammation in older adults undergoing resistance exercise. Participants will be randomized into the 4 groups. The placebo group will receive 5 g per day of sunflower oil and 38 g per day of maltodextrin. The omega 3 + placebo group will receive 5 g per day of fish oil and 38 g per day of maltodextrin. The whey protein + placebo group will receive 38g per day of whey and 5g per day of sunflower oil. The omega 3 + whey group will receive 5g per day of fish oil and 38g per day of protein. All will perform the same exercise protocol for 12 weeks.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
60 Years 至 80 Years(Adult, Older Adult)
性别
Female
接受健康志愿者
是

入选标准

  • •Postmenopausal women (at least 1 year of menstrual interruption, self-reported);
  • •To be able to practice strength exercises;
  • •To be able to carry out supplementation;
  • •Do not present physical, orthopedic or cardiovascular complications that prevent the performance of physical exercises;
  • •No history of stroke or acute myocardial infarction;
  • •Not being a smoker and/or alcoholic;
  • •Do not perform hormone replacement therapy;
  • •Do not use anti-inflammatory drugs;
  • •To have normal kidney function;
  • •To submit a medical certificate of health that proves that the individual is able to perform exercises.

排除标准

  • •Do not provide the necessary information for the development of the study;
  • •Individuals with diseases previously diagnosed and undergoing treatment, such as type II diabetes mellitus, cancer, rheumatoid arthritis, cardiovascular, and kidney and/or liver diseases.

研究组 & 干预措施

Whey Protein + Placebo

Experimental

Group supplemented with isolated whey protein (38g/day) and sunflower oil (5g/day). All groups will undergo a training program with strength exercises for 12 weeks.

干预措施: Whey Protein + Placebo (Dietary Supplement)

Omega 3 + Placebo

Experimental

Group supplemented with omega-3 (5g/day) and maltodextrin (38g/day). All groups will undergo a training program with strength exercises for 12 weeks.

干预措施: Omega 3 + Placebo (Dietary Supplement)

Omega 3 + Whey Protein

Experimental

Group supplemented with omega-3 (5g/day) and whey protein (38g/day). All groups will undergo a training program with strength exercises for 12 weeks.

干预措施: Omega 3 + Whey Protein (Dietary Supplement)

Placebo Group

Placebo Comparator

Group supplemented with maltodextrin (38g/day) and sunflower oil (5g/day). All groups will undergo a training program with strength exercises for 12 weeks

干预措施: Placebo Group (Dietary Supplement)

结局指标

主要结局

Changes in lean mass (kg) using ultrasound and dual-energy X-ray absorptiometry (DXA) in postmenopausal women

时间窗: up to 12 weeks

Changes in lean mass (kg) using ultrasound and electrical bioimpedance in postmenopausal women

时间窗: up to 12 weeks

次要结局

  • Changes in strength (kg) using dynamometer in postmenopausal women(up to 12 weeks)

研究者

发起方
Federal University of Uberlandia
申办方类型
Other
责任方
Principal Investigator
主要研究者

Erick Prado de Oliveira

Assistant professor

Federal University of Uberlandia

研究点 (2)

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