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临床试验/NCT03386461
NCT03386461已完成不适用

Effect of Exercise Training and Omega-3 Fatty Acids on Metabolic Health and Dysfunction of Adipose Tissue in Elderly

Charles University, Czech Republic1 个研究点 分布在 1 个国家目标入组 55 人开始时间: 2017年1月5日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
55
试验地点
1
主要终点
Change in adipose tissue inflammatory signalling

研究概览

简要总结

The aim of this project is to investigate in elderly women, the effect of combined aerobic and resistive training and concomitant supplementation with omega-3 fatty acids on adipogenesis, metabolic functions and pro-inflammatory status of adipose tissue and on systemic metabolic profile.

详细描述

Aging is associated with development of disturbances of lipid and carbohydrate metabolism and with systemic pro-inflammatory state similarly to the alterations observed in obese individuals. Metabolic and immune dysfunction of adipose tissue has been suggested as an important contributing trigger to this condition. EXODYA project is a clinical study in elderly individuals that aims to establish benefits of lifestyle intervention and nutritional supplementation -either alone or in combination- for the amelioration of systemic and adipose tissue metabolic and immune disturbances. Effects of 4 months´ intervention with combined aerobic plus resistive exercise training and supplementation with omega-3 polyunsaturated fatty acids on systemic metabolic profile and molecular characteristics of adipose tissue will be investigated in elderly women. Thus, a proof-of-concept will be provided for novel recommendations and guidelines for lifestyle interventions in elderly population

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Double (Participant, Care Provider)

盲法说明

Two types of pills (calanus or placebo) will be prescribed to subjects, investigator will randomly assign the subjects to the arms

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

  • •elderly women: age 60-80
  • •non-trained (without regular physical activity)
  • •BMI in the range of 25-30 kg/m2

排除标准

  • •diagnosed cancer, diabetes, liver and renal diseases, untreated hyper- or hypo-thyroidism, long term use of anti-inflammatory medication (anti-rheumatics and analgesics affecting cyclooxygenases (100 mg of anopyrin daily is acceptable), steroids and/or Omega-3 dietary supplements

研究组 & 干预措施

Exercise + Omega 3 supplementation

Experimental

Subjects will be enrolled in physical activity program that consists of combined aerobic and resistive training 3 times a week for 4 months. Training will be supervised by physiotherapists experienced in exercise training of elderly (Senior Fitness, and Faculty of Physical Education and Sport). Subjects will take 5 capsules od Calanus oil (containing approx. 250 mg EPA and DHA per day).

干预措施: Exercise training (Behavioral)

Exercise + Omega 3 supplementation

Experimental

Subjects will be enrolled in physical activity program that consists of combined aerobic and resistive training 3 times a week for 4 months. Training will be supervised by physiotherapists experienced in exercise training of elderly (Senior Fitness, and Faculty of Physical Education and Sport). Subjects will take 5 capsules od Calanus oil (containing approx. 250 mg EPA and DHA per day).

干预措施: omega 3 supplementation (Dietary Supplement)

Exercise + placebo

Placebo Comparator

Subjects will be enrolled in physical activity program that consists of combined aerobic and resistive training 3 times a week for 4 months. Training will be supervised by physiotherapists experienced in exercise training of elderly. Subjects will take 5 capsules od placebo per day (provided by Calanus oil company, containing sunflower oil).

干预措施: Exercise training (Behavioral)

Exercise + placebo

Placebo Comparator

Subjects will be enrolled in physical activity program that consists of combined aerobic and resistive training 3 times a week for 4 months. Training will be supervised by physiotherapists experienced in exercise training of elderly. Subjects will take 5 capsules od placebo per day (provided by Calanus oil company, containing sunflower oil).

干预措施: placebo (Dietary Supplement)

结局指标

主要结局

Change in adipose tissue inflammatory signalling

时间窗: through study completion, an average of 1 year

analysis of pro-resolving mediators (UPLC-MS/MS methodology)

Change in adipose tissue inflammation

时间窗: through study completion, an average of 1 year

analysis of distribution of immune cells (flow cytometry analysis)

次要结局

  • Change in gene expression in adipose tissue(through study completion, an average of 1 year)
  • Change in insulin sensitivity(through study completion, an average of 1 year)
  • Change in physical performance(through study completion, an average of 1 year)

研究者

发起方
Charles University, Czech Republic
申办方类型
Other
责任方
Principal Investigator
主要研究者

Michaela Siklova

Principal Investigator

Charles University, Czech Republic

研究点 (1)

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