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

NCT03746977 | Completed

• 1 other identifier: WREPP
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Overweight; Obesity; Abdominal Obesity

Keywords

exercise; electromyostimulation; protein; weight reduction

Outcome Measures

Primary Outcomes (1)

• Lean body mass

  Fat and bone free total body mass in kg

  changes from baseline to 16 week follow-up

Secondary Outcomes (6)

• Total Body Fat

  changes from baseline to 16 week follow-up

• Total Body Fat Rate

  changes from baseline to 16 week follow-up

• Appendicular Skeletal Muscle Mass

  changes from baseline to 16 week follow-up

• Visceral Body Fat

  changes from baseline to 16 week follow-up

• Trunk fat

  changes from baseline to 16 week follow-up

Study Arms (3)

energy restriction and protein supplementation

ACTIVE COMPARATOR

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

Dietary Supplement: Protein

Energy restriction, walking and protein

ACTIVE COMPARATOR

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

Energy restriction, walking, protein and WB-EMS

ACTIVE COMPARATOR

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

Protein DIETARY_SUPPLEMENT

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

Energy restriction, walking and protein; Energy restriction, walking, protein and WB-EMS; energy restriction and protein supplementation

Walking BEHAVIORAL

Walking with a volume corresponding to 250 kcal/d

Energy restriction, walking and protein; Energy restriction, walking, protein and WB-EMS

WB-EMS application BEHAVIORAL

WB-EMS application 1.5x 20 min/week

Energy restriction, walking, protein and WB-EMS

Eligibility Criteria

• Age: 25 Years - 50 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Erlangen-Nürnberg Medical School: lead

Study Sites (1)

Institute of Medical Physics University of Erlangen-Nurnberg

Erlangen, 91052, Germany

Location

MeSH Terms

Conditions

Overweight; Obesity; Obesity, Abdominal; Motor Activity; Weight Loss

Interventions

Proteins; Walking

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior; Body Weight Changes

Intervention Hierarchy (Ancestors)

Amino Acids, Peptides, and Proteins; Locomotion; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Exercise; Motor Activity

Study Officials

• Simon von Stengel, PhD

  Institute of Medical Physics, FAU Erlangen-Nürnberg, Germany

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Dr. Wolfgang Kemmler, Principal Investigator

Model Details: Randomized controlled parallel group design with 3 study arms

Study Record Dates

• First Submitted: November 13, 2018
• First Posted: November 20, 2018
• Study Start: January 25, 2018
• Primary Completion: November 30, 2018
• Study Completion: December 1, 2018
• Last Updated: March 18, 2019

Record last verified: 2019-03

Locations

DE (1)