Clinical trial NCT03746977: Effects of WB-EMS and Protein Supplementation on LBM Maintenance During Intended Weight Loss
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight
Obesity
Abdominal Obesity
Keywords: exercise
electromyostimulation
protein
weight reduction
Lead sponsor: University of Erlangen-Nürnberg Medical School
Sponsor class: OTHER
First posted: 2018-11-20
Enrollment: 30
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled parallel group design with 3 study arms
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Lean body mass
timeFrame: changes from baseline to 16 week follow-up
Secondary outcomes:
measure: Total Body Fat
timeFrame: changes from baseline to 16 week follow-up
measure: Total Body Fat Rate
timeFrame: changes from baseline to 16 week follow-up
measure: Appendicular Skeletal Muscle Mass
timeFrame: changes from baseline to 16 week follow-up
measure: Visceral Body Fat
timeFrame: changes from baseline to 16 week follow-up
measure: Trunk fat
timeFrame: changes from baseline to 16 week follow-up
measure: Metabolic Syndrome Z-Score
timeFrame: changes from baseline to 16 week follow-up
Other outcomes:
Locations:
city: Erlangen
country: Germany
facility: Institute of Medical Physics University of Erlangen-Nurnberg
Study officials:
affiliation: Institute of Medical Physics, FAU Erlangen-Nürnberg, Germany
name: Simon von Stengel, PhD
role: STUDY_CHAIR
References: