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Completed

NCT Number: NCT03102372

Preservation of Fat Free Mass During Weight Loss

In this study, we aimed to examine the effect of whey protein supplementation given before night sleep on Fat Free Mass (FFM) preservation during a 4 wk period on Very Low Caloric Diet (VLCD).

Half of the participants underwent a 4 week VLCD and walking program, while the other half underwent a 4 week VLCD, walking program and had an additional protein supplement before each night sleep.

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Key information

Conditions

Muscle Loss Atrophy Behavior Body Weight Motor Activity Muscular Atrophy Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Body Mass Index (kg/m^2) > 28
  • Age between 18 and 55 years

Exclusion criteria

  • Participation in regular resistance-, aerobic- or anaerobic training (>1 h/wk within the last 3 month before intervention start)
  • Diabetes Physical disabilities that would hinder completion of the walking program.

Treatment and study plan

Whey protein supplementation

Dietary Supplement

Walking program

Other

very low calorie diet

Other

Primary outcomes

  1. Fat Free Mass

    Time frame: Change from baseline to after the 4 week intervention period

    Dual energy X-ray absorptiometry (DXA)

Secondary outcomes

  1. Nitrogen balance

    Time frame: Change in nitrogen content from baseline to day 7 and 28 of the intervention period

    Three 24 hours urin samples

  2. Oral glucose tolerance test

    Time frame: Change from baseline to after the 4 week intervention period

    OGTT

  3. Fitness level

    Time frame: Change from baseline to after the 4 week intervention period

    Bike test

  4. Blood pressure

    Time frame: Change from baseline to after the 4 week intervention period

    Blood pressure at rest

  5. Fat mass

    Time frame: Change from baseline to after the 4 week intervention period

    DXA

  6. waist circumference

    Time frame: Change from baseline to after the 4 week intervention period

    waist circumference

  7. Performance test

    Time frame: Change from baseline to after the 4 week intervention period

    Intermittent running test (YY1R1C)

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

  • Orkla Health
  • Toyota-Fonden
  • Tømmerhandler Vilhelm Bangs Fond

Registry information

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Apr 5, 2017
Registry last updated
Apr 7, 2017

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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