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Completed

NCT Number: NCT03746977

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

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.

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Key information

Conditions

Overweight Abdominal Obesity Behavior Body Weight Body Weight Changes Motor Activity Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity, Abdominal Overnutrition Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Loss

Age range

25 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Institute of Medical Physics University of Erlangen-Nurnberg

Erlangen, 91052, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Protein

Dietary Supplement

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

Walking

Behavioral

Walking with a volume corresponding to 250 kcal/d

WB-EMS application

Behavioral

WB-EMS application 1.5x 20 min/week

Primary outcomes

  1. Lean body mass

    Time frame: changes from baseline to 16 week follow-up

    Fat and bone free total body mass in kg

Secondary outcomes

  1. Total Body Fat

    Time frame: changes from baseline to 16 week follow-up

    Total Body Fat in kg

  2. Total Body Fat Rate

    Time frame: changes from baseline to 16 week follow-up

    Percent Total Body Fat Rate

  3. Appendicular Skeletal Muscle Mass

    Time frame: changes from baseline to 16 week follow-up

    Lean Body Mass of the upper and lower limbs in kg

  4. Visceral Body Fat

    Time frame: changes from baseline to 16 week follow-up

    Total visceral body fat in kg

  5. Trunk fat

    Time frame: changes from baseline to 16 week follow-up

    Total trunk fat in kg

  6. Metabolic Syndrome Z-Score

    Time frame: changes from baseline to 16 week follow-up

    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

Sponsors and collaborators

Lead sponsor

University of Erlangen-Nürnberg Medical School

Other

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Nov 20, 2018
Registry last updated
Mar 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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