Effects of WB-EMS and Protein Supplementation on LBM Maintenance During Intended Weight Loss

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Overweight, Obesity, Abdominal Obesity

Intervention / Treatment
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* Dietary Supplement: Protein
* Behavioral: Walking
* Behavioral: WB-EMS application


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized controlled parallel group design with 3 study arms
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: energy restriction and protein supplementation<br>Energy restriction of 500 kcal/d and total Protein Uptake (including Supplementation) of 1.2 g/kg body mass/d | Dietary Supplement: Protein<br>* Protein supplementation 1.2 or 1.5 g/kg body mass/d<br>|
| Active Comparator: Energy restriction, walking and protein<br>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 | Dietary Supplement: Protein<br>* Protein supplementation 1.2 or 1.5 g/kg body mass/d<br>Behavioral: Walking<br>* Walking with a volume corresponding to 250 kcal/d<br>|
| Active Comparator: Energy restriction, walking, protein and WB-EMS<br>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 | Dietary Supplement: Protein<br>* Protein supplementation 1.2 or 1.5 g/kg body mass/d<br>Behavioral: Walking<br>* Walking with a volume corresponding to 250 kcal/d<br>Behavioral: WB-EMS application<br>* WB-EMS application 1.5x 20 min/week<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lean body mass | Fat and bone free total body mass in kg | changes from baseline to 16 week follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Body Fat | Total Body Fat in kg | changes from baseline to 16 week follow-up | 
| Total Body Fat Rate | Percent Total Body Fat Rate | changes from baseline to 16 week follow-up | 
| Appendicular Skeletal Muscle Mass | Lean Body Mass of the upper and lower limbs in kg | changes from baseline to 16 week follow-up | 
| Visceral Body Fat | Total visceral body fat in kg | changes from baseline to 16 week follow-up | 
| Trunk fat | Total trunk fat in kg | changes from baseline to 16 week follow-up | 
| Metabolic Syndrome Z-Score | Summarized Z-Score that included Z-Scores of blood lipids, lipoproteins, glucose, resting blood pressure and waist circumference. Cut-offs based on the definition of the International Diabetes Federations | changes from baseline to 16 week follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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exercise, electromyostimulation, protein, weight reduction