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

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

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Overweight; Abdominal Obesity
• Intervention / Treatment: Dietary supplement: Protein; Behavioral: Walking; Behavioral: WB-EMS application

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Erlangen, Germany, 91052
    • Institute of Medical Physics University of Erlangen-Nurnberg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Erlangen-Nürnberg Medical School
• Investigators: Study Chair: Simon von Stengel, PhD, Institute of Medical Physics, FAU Erlangen-Nürnberg, Germany

Study record dates

Study Major Dates

• Study Start (Actual): January 25, 2018
• Primary Completion (Actual): November 30, 2018
• Study Completion (Actual): December 1, 2018

Study Registration Dates

• First Submitted: November 13, 2018
• First Submitted That Met QC Criteria: November 19, 2018
• First Posted (Actual): November 20, 2018

Study Record Updates

• Last Update Posted (Actual): March 18, 2019
• Last Update Submitted That Met QC Criteria: March 15, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: exercise; protein; weight reduction; electromyostimulation
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Body Weight; Body Weight Changes; Obesity; Weight Loss; Overweight; Obesity, Abdominal
• Other Study ID Numbers: WREPP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No