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

NCT ID: NCT03746977

Last Updated: 2019-03-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-25

Study Completion Date

2018-12-01

Brief Summary

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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.

Detailed Description

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Conditions

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Overweight Obesity Abdominal Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized controlled parallel group design with 3 study arms
Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors
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.

Study Groups

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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

Group Type ACTIVE_COMPARATOR

Protein

Intervention Type DIETARY_SUPPLEMENT

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

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

Group Type ACTIVE_COMPARATOR

Protein

Intervention Type DIETARY_SUPPLEMENT

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

Walking

Intervention Type BEHAVIORAL

Walking with a volume corresponding to 250 kcal/d

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

Group Type ACTIVE_COMPARATOR

Protein

Intervention Type DIETARY_SUPPLEMENT

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

Walking

Intervention Type BEHAVIORAL

Walking with a volume corresponding to 250 kcal/d

WB-EMS application

Intervention Type BEHAVIORAL

WB-EMS application 1.5x 20 min/week

Interventions

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Protein

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

Intervention Type DIETARY_SUPPLEMENT

Walking

Walking with a volume corresponding to 250 kcal/d

Intervention Type BEHAVIORAL

WB-EMS application

WB-EMS application 1.5x 20 min/week

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

25 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Erlangen-Nürnberg Medical School

OTHER

Sponsor Role lead

Responsible Party

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Wolfgang Kemmler

Professor Dr. Wolfgang Kemmler, Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Simon von Stengel, PhD

Role: STUDY_CHAIR

Institute of Medical Physics, FAU Erlangen-Nürnberg, Germany

Locations

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Institute of Medical Physics University of Erlangen-Nurnberg

Erlangen, , Germany

Site Status

Countries

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Germany

Other Identifiers

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WREPP

Identifier Type: -

Identifier Source: org_study_id

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