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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03746977
Other study ID # WREPP
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


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
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