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临床试验/NCT03746977
NCT03746977已完成不适用

Effects of Whole-body Electromyostimulation (WB-EMS), Physical Activity and Protein Supplementation on Lean Body Mass Maintenance During Caloric Restriction and Physical Activity Induced Weight Loss. A Randomized Controlled Study

University of Erlangen-Nürnberg Medical School2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2018年1月25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
30
试验地点
2
主要终点
Lean body mass

研究概览

简要总结

The present study aimed to determine the effect of different interventions on lean body mass maintenance under weight loss conditions in overweight and obese premenopausal women. Three study groups were implemented: (1) Protein supplementation (only) group (2) Protein supplementation and walking intervention (3) Protein supplementation, walking and WB-EMS-application. All protocols were applied for 16 week of intervention.

A energy deficit of 500 kcal/d was intended however while group (1) focus consistently on energy restriction (500 kcal/d), in group (2) and (3) a combined physical activity (i.e. walking with a volume representing 250 kcal/d) and energy restriction (250 kcal/d) protocol was applied. Total protein uptake including protein supplementation was calculated to average around 1.2 g/kg body mass per day in groups (1) and 1.5 g/kg body mass/d in group (2) and (3). WB-EMS was applied 1.5x 20 min/week (i.e. each Tuesday and every second Thursday).

Primary study endpoint was LBM as determined by Dual Energy x-Ray Absorptiometry.

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
Double (Participant, Outcomes Assessor)

盲法说明

Outcome assessors were not aware of the status of the participants and were not allowed to ask correspondingly. Each of the participants were blinded according to the treatment and intervention. Participants of the three study groups were not in contact.

入排标准

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

入选标准

  • premenopausal women 25-50 years old
  • overweight/obesity (body fat rate equal or higher 30%)

排除标准

  • medication and diseases affecting muscle and fat metabolism
  • pregnant or parturition < 6 months
  • any condition or medication that prevent proper physical activity or WB-EMS application
  • holidays equal or more than 1 week during the intervention period
  • other interventions with impact on the primary and core secondary outcome (i.e. body fat parameters) started during the last year.

研究组 & 干预措施

energy restriction and protein supplementation

Active Comparator

Energy restriction of 500 kcal/d and total Protein Uptake (including Supplementation) of 1.2 g/kg body mass/d

干预措施: Protein (Dietary Supplement)

Energy restriction, walking and protein

Active Comparator

Energy restriction of 250 kcal/d, increased energy consumption by walking (250 kcal/d) and total protein uptake (including supplementation) of 1.5 g/kg body mass/d

干预措施: Protein (Dietary Supplement)

Energy restriction, walking and protein

Active Comparator

Energy restriction of 250 kcal/d, increased energy consumption by walking (250 kcal/d) and total protein uptake (including supplementation) of 1.5 g/kg body mass/d

干预措施: Walking (Behavioral)

Energy restriction, walking, protein and WB-EMS

Active Comparator

Energy restriction of 250 kcal/d, increased energy consumption by walking (250 kcal/d), total protein uptake (including supplementation) of 1.5 g/kg body mass/d and WB-EMS application 1,5x 20 min/week

干预措施: Protein (Dietary Supplement)

Energy restriction, walking, protein and WB-EMS

Active Comparator

Energy restriction of 250 kcal/d, increased energy consumption by walking (250 kcal/d), total protein uptake (including supplementation) of 1.5 g/kg body mass/d and WB-EMS application 1,5x 20 min/week

干预措施: Walking (Behavioral)

Energy restriction, walking, protein and WB-EMS

Active Comparator

Energy restriction of 250 kcal/d, increased energy consumption by walking (250 kcal/d), total protein uptake (including supplementation) of 1.5 g/kg body mass/d and WB-EMS application 1,5x 20 min/week

干预措施: WB-EMS application (Behavioral)

结局指标

主要结局

Lean body mass

时间窗: changes from baseline to 16 week follow-up

Fat and bone free total body mass in kg

次要结局

  • Visceral Body Fat(changes from baseline to 16 week follow-up)
  • Trunk fat(changes from baseline to 16 week follow-up)
  • Total Body Fat(changes from baseline to 16 week follow-up)
  • Appendicular Skeletal Muscle Mass(changes from baseline to 16 week follow-up)
  • Metabolic Syndrome Z-Score(changes from baseline to 16 week follow-up)
  • Total Body Fat Rate(changes from baseline to 16 week follow-up)

研究者

发起方
University of Erlangen-Nürnberg Medical School
申办方类型
Other
责任方
Principal Investigator
主要研究者

Wolfgang Kemmler

Professor Dr. Wolfgang Kemmler, Principal Investigator

University of Erlangen-Nürnberg Medical School

研究点 (2)

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