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CompletedNCT03746977Updated Mar 18, 2019

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

An interventional study of Protein and Walking in Overweight, Obesity and Abdominal Obesity, sponsored by University of Erlangen-Nürnberg Medical School. Completed at 1 site in Germany. Open to female participants aged 25 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-03-18.

Sponsored by University of Erlangen-Nürnberg Medical School · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 9 months after the study started (first participant enrolled Jan 2018, registered Nov 2018).
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
25 Years to 50 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Overweight
  • Obesity
  • Abdominal Obesity

Keywords

  • exercise
  • electromyostimulation
  • protein
  • weight reduction
03

In context

Overweight

3,767 studies on the registry are indexed under Overweight; 863 are open to participants now.

This study's enrollment of 30 is below the median of 73 across 3,263 interventional studies indexed under Overweight.

Browse Overweight studies →

Lead sponsor

University of Erlangen-Nürnberg Medical School is the lead sponsor of 275 studies on the registry; 52 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
25 Years to 50 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
30 participants (actual)

Study arms

  • 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

  • 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 · Behavioral: Walking

  • 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 · Behavioral: Walking · Behavioral: WB-EMS application

Interventions

  • Dietary supplementProtein

    Protein supplementation 1.2 or 1.5 g/kg body mass/d

  • BehavioralWalking

    Walking with a volume corresponding to 250 kcal/d

  • BehavioralWB-EMS application

    WB-EMS application 1.5x 20 min/week

06

What researchers measure

Primary outcomes

  1. Lean body mass

    Fat and bone free total body mass in kg

    Time frame: changes from baseline to 16 week follow-up

Secondary outcomes

  1. Total Body Fat

    Total Body Fat in kg

    Time frame: changes from baseline to 16 week follow-up

  2. Total Body Fat Rate

    Percent Total Body Fat Rate

    Time frame: changes from baseline to 16 week follow-up

  3. Appendicular Skeletal Muscle Mass

    Lean Body Mass of the upper and lower limbs in kg

    Time frame: changes from baseline to 16 week follow-up

  4. Visceral Body Fat

    Total visceral body fat in kg

    Time frame: changes from baseline to 16 week follow-up

  5. Trunk fat

    Total trunk fat in kg

    Time frame: changes from baseline to 16 week follow-up

  6. 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

    Time frame: changes from baseline to 16 week follow-up

07

Study locations

1 site
  • Institute of Medical Physics University of Erlangen-Nurnberg
    Erlangen, 91052, Germany
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 18, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03746977
Responsible party
Wolfgang Kemmler (Professor Dr. Wolfgang Kemmler, Principal Investigator, University of Erlangen-Nürnberg Medical School) — Principal investigator
First posted
Nov 20, 2018
Start date
Jan 25, 2018
Primary completion
Nov 30, 2018
Completion
Dec 1, 2018
Last update
Mar 18, 2019

Study contacts

Simon von Stengel, PhD
study chair · Institute of Medical Physics, FAU Erlangen-Nürnberg, Germany

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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