search
Back to results

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

Primary Purpose

Overweight, Obesity, Abdominal Obesity

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Protein
Walking
WB-EMS application
Sponsored by
University of Erlangen-Nürnberg Medical School
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Overweight focused on measuring exercise, electromyostimulation, protein, weight reduction

Eligibility Criteria

25 Years - 50 Years (Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Institute of Medical Physics University of Erlangen-Nurnberg

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

energy restriction and protein supplementation

Energy restriction, walking and protein

Energy restriction, walking, protein and WB-EMS

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Lean body mass
Fat and bone free total body mass in kg

Secondary Outcome Measures

Total Body Fat
Total Body Fat in kg
Total Body Fat Rate
Percent Total Body Fat Rate
Appendicular Skeletal Muscle Mass
Lean Body Mass of the upper and lower limbs in kg
Visceral Body Fat
Total visceral body fat in kg
Trunk fat
Total trunk fat in kg
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

Full Information

First Posted
November 13, 2018
Last Updated
March 15, 2019
Sponsor
University of Erlangen-Nürnberg Medical School
search

1. Study Identification

Unique Protocol Identification Number
NCT03746977
Brief Title
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

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
January 25, 2018 (Actual)
Primary Completion Date
November 30, 2018 (Actual)
Study Completion Date
December 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Erlangen-Nürnberg Medical School

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Obesity, Abdominal Obesity
Keywords
exercise, electromyostimulation, protein, weight reduction

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled parallel group design with 3 study arms
Masking
ParticipantOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
energy restriction and protein supplementation
Arm Type
Active Comparator
Arm Description
Energy restriction of 500 kcal/d and total Protein Uptake (including Supplementation) of 1.2 g/kg body mass/d
Arm Title
Energy restriction, walking and protein
Arm Type
Active Comparator
Arm Description
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
Arm Title
Energy restriction, walking, protein and WB-EMS
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Dietary Supplement
Intervention Name(s)
Protein
Intervention Description
Protein supplementation 1.2 or 1.5 g/kg body mass/d
Intervention Type
Behavioral
Intervention Name(s)
Walking
Intervention Description
Walking with a volume corresponding to 250 kcal/d
Intervention Type
Behavioral
Intervention Name(s)
WB-EMS application
Intervention Description
WB-EMS application 1.5x 20 min/week
Primary Outcome Measure Information:
Title
Lean body mass
Description
Fat and bone free total body mass in kg
Time Frame
changes from baseline to 16 week follow-up
Secondary Outcome Measure Information:
Title
Total Body Fat
Description
Total Body Fat in kg
Time Frame
changes from baseline to 16 week follow-up
Title
Total Body Fat Rate
Description
Percent Total Body Fat Rate
Time Frame
changes from baseline to 16 week follow-up
Title
Appendicular Skeletal Muscle Mass
Description
Lean Body Mass of the upper and lower limbs in kg
Time Frame
changes from baseline to 16 week follow-up
Title
Visceral Body Fat
Description
Total visceral body fat in kg
Time Frame
changes from baseline to 16 week follow-up
Title
Trunk fat
Description
Total trunk fat in kg
Time Frame
changes from baseline to 16 week follow-up
Title
Metabolic Syndrome Z-Score
Description
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

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Simon von Stengel, PhD
Organizational Affiliation
Institute of Medical Physics, FAU Erlangen-Nürnberg, Germany
Official's Role
Study Chair
Facility Information:
Facility Name
Institute of Medical Physics University of Erlangen-Nurnberg
City
Erlangen
ZIP/Postal Code
91052
Country
Germany

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs