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

Obesity Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03746977
• Other study ID #: WREPP
• Status: Completed
• Phase: N/A
• Start date: January 25, 2018
• Est. completion date: December 1, 2018

Study information

• Verified date: March 2019
• Source: University of Erlangen-Nürnberg Medical School
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 1, 2018
• Est. primary completion date: November 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 25 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Abdominal Obesity
• Obesity
• Obesity, Abdominal
• Overweight
• Weight Loss

Intervention

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
• WB-EMS application
WB-EMS application 1.5x 20 min/week

Locations

Country	Name	City	State
Germany	Institute of Medical Physics University of Erlangen-Nurnberg	Erlangen

Sponsors (1)

Lead Sponsor	Collaborator
University of Erlangen-Nürnberg Medical School

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lean body mass	Fat and bone free total body mass in kg	changes from baseline to 16 week follow-up
Secondary	Total Body Fat	Total Body Fat in kg	changes from baseline to 16 week follow-up
Secondary	Total Body Fat Rate	Percent Total Body Fat Rate	changes from baseline to 16 week follow-up
Secondary	Appendicular Skeletal Muscle Mass	Lean Body Mass of the upper and lower limbs in kg	changes from baseline to 16 week follow-up
Secondary	Visceral Body Fat	Total visceral body fat in kg	changes from baseline to 16 week follow-up
Secondary	Trunk fat	Total trunk fat in kg	changes from baseline to 16 week follow-up
Secondary	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