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临床试验/NCT04098484
NCT04098484已完成不适用

Biological Adaptations of Strength Training to Obese and Normal Weight Middle-aged Men

Democritus University of Thrace2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2019年4月2日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
2
主要终点
Changes in HDL concentration

研究概览

简要总结

A two-trial repeated measures design will be employed in this investigation. Both the control trial and the exercise trial will last for 3 months. During a week before the start of the study, participants will complete dietary recalls and record their habitual physical activity using accelerometers. Thereafter, body composition, ultrasound imaging of the muscle and liver, biochemical and hematological markers were measured. This range of measurements will be repeated the ended each month for both trials. Control trial succeeds exercise trial. An exercise intervention program will take place in the second trial, three times a week.

详细描述

A sample size of 30 volunteers, aged 35-45 years, will participate in the present study. Of them, 15 will be normal weight and 15 will suffer from fatty liver disease (BMI 29-35 kg/m2, waist size >102 cm). The exclusion criteria will be a) medication, b) musculoskeletal problems that will prevent participation in the training program, c) known condition or medical condition preventing participation in the program e.g. hypertension, d) BMI> 35kg / m2, (e) a severe family medical history up to first degree relatives with cardiovascular disease and / or diabetes at the age of less than 65 for women and less than 55 years for men and (f) smoking. After informing and receiving a questionnaire and medical history, volunteers will sign for their participation in the survey.

A two-trial repeated measures design will be applied in this investigation. Both control and exercise trials will last for 3 months. During the week preceding the commencement of the study, participants will complete dietary recalls and will have their habitual physical activity monitored, by utilizing accelerometers. Thereafter, body composition, ultrasound imaging of muscle and liver, biochemical and hematological markers will be measured. The same measurements will be repeated at the end of each month, in both trials. Control trial will be executed prior to exercise trial. An exercise intervention program, combining strength and cardiovascular exercises performed three times a week, will take place in the exercise trial.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
35 Years 至 50 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • no use of medication
  • free of musculoskeletal limitations
  • absence of a known condition or medical condition preventing participation in the program (e.g. hypertension)
  • absence of a severe family medical history up to first degree relatives with cardiovascular disease and /or diabetes at the age of less than 65 for women and less than 55 years for men
  • non-smokers

排除标准

  • use of medication
  • musculoskeletal limitations that will prevent participation in the training program
  • known condition or medical condition preventing participation in the program (e.g. hypertension)
  • a severe family medical history up to first degree relatives with cardiovascular disease and /or diabetes at the age of less than 65 for women and less than 55 years for men

结局指标

主要结局

Changes in HDL concentration

时间窗: At baseline as well as at 1,5 and 3 months in both trials

HDL concentration will be measured in blood

Changes in total cholesterol

时间窗: At baseline as well as at 1,5 and 3 months in both trials

Total cholesterol levels will measured in blood

Changes in glycosylated hemoglobin

时间窗: At baseline as well as at 1,5 and 3 months in both trials

Glycosylated hemoglobin levels will be measured in blood

Changes in total antioxidant capacity

时间窗: At baseline as well as at 1,5 and 3 months in both trials

Total antioxidant capacity will be assessed in plasma

Changes in Red Blood Cells

时间窗: At baseline as well as at 1,5 and 3 months in both trials

Red blood cells will be measured in bood samples

Changes in body composition

时间窗: At baseline as well as at 1,5 and 3 months in both trials

Body composition will be assessed using Dual-energy-X-ray Absorptiometry (DXA) instrumentation

Changes in glucose

时间窗: At baseline as well as at 1,5 and 3 months in both trials

Glucose concentration will be measured in blood

Changes in insulin

时间窗: At baseline as well as at 1,5 and 3 months in both trials

Insulin concentration will be measured in blood

Changes in insulin resistance index

时间窗: At baseline as well as at 1,5 and 3 months in both trials

Insulin resistance index will be calculated through glucose and insulin values

Changes in transaminases

时间窗: At baseline as well as at 1,5 and 3 months in both trials

Transaminase levels will be measured in blood samples

Changes in C-reactive protein

时间窗: At baseline as well as at 1,5 and 3 months in both trials

C-reactive protein levels will be measured in blood samples

Changes in White Blood Cells

时间窗: At baseline as well as at 1,5 and 3 months in both trials

White blood cells will be measured in bood samples

Changes in Hemoglobin

时间窗: At baseline as well as at 1,5 and 3 months in both trials

Hemoglobin will be measured in blood samples

Changes in Hematocrit

时间窗: At baseline as well as at 1,5 and 3 months in both trials

Hematocrit levels will be measured in blood samples

Changes in protein carbonyls

时间窗: At baseline as well as at 1,5 and 3 months in both trials

Protein carbonyl formation will be measured in serum

Changes in thiobarbituric acid reactive substances (TBARS)

时间窗: At baseline as well as at 1,5 and 3 months in both trials

TBARS will be measured in serum

Changes in catalase

时间窗: At baseline as well as at 1,5 and 3 months in both trials

Catalase activity will be measured in serum

Changes in fatty infiltration of the liver

时间窗: At baseline as well as at 1,5 and 3 months in both trials

Fatty infiltration of the liver will be assessed by ultrasound imaging of liver

Changes in LDL concentration

时间窗: At baseline as well as at 1,5 and 3 months in both trials

LDL concentration will be measured in blood

Changes in triglycerides

时间窗: At baseline as well as at 1,5 and 3 months in both trials

Triglycerides concentration will be measured in blood

Changes in free fatty acids

时间窗: At baseline as well as at 1,5 and 3 months in both trials

Free fatty acid concentration will be measured in blood

Changes in glutathione

时间窗: At baseline as well as at 1,5 and 3 months in both trials

Oxidized (GSH) and reduced (GSSG) glutathione will be measured in red blood cell lysate

Changes in bone status

时间窗: At baseline as well as at 1,5 and 3 months in both trials

Bone mineral density and bone mineral content will be assessed in hole body, spine and hips using DXA

次要结局

  • Changes in body weight(At baseline as well as at 1,5 and 3 months in both trials)
  • Changes in muscle architecture(At baseline as well as at 1,5 and 3 months in both trials)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Athanasios Chatzinikolaou

Associate Professor

Democritus University of Thrace

研究点 (2)

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