Trial document





This trial has been registered retrospectively.
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  DRKS00006003

Trial Description

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Title

Influence of collagen hydrolysate on muscle mass in subjects with sarcopenia

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

To determine the effect of post-exercise protein supplementation with collagen hydrolysate vs placebo on muscle mass and muscle function following resistance training in subjects with sarcopenia.
The study is a double blinded randomized controlled study consisting of a three month guided resistance training program on fitness devices with collagen hydrolysate as supplement (TG) vs silica as placebo (PG).
60 males aged between 65 and 90 y with sarcopenia (class I or II) without acute diseases or illness related cachexia will be enrolled in the study.
Before and after the training program fat free mass (FFM), fat mass (FM) and bone mass (BM) will be measured using DXA. Isokinetic quadriceps strength of the right leg will be determined and sensory motor control will be investigated by a standardized one-leg stabilization test, both before and after the training program.

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Brief Summary in Scientific Language

To determine the effect of post-exercise protein supplementation with collagen hydrolysate vs placebo on muscle mass and muscle function following resistance training in subjects with sarcopenia.
The study is a double blinded randomized controlled study consisting of a three month guided resistance training program on fitness devices with collagen hydrolysate as supplement (TG) vs silica as placebo (PG).
60 males aged between 65 and 90 y with sarcopenia (class I or II) without acute diseases or illness related cachexia will be enrolled in the study.
Before and after the training program fat free mass (FFM), fat mass (FM) and bone mass (BM) will be measured using DXA. Isokinetic quadriceps strength of the right leg will be determined and sensory motor control will be investigated by a standardized one-leg stabilization test, both before and after the training program.

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Organizational Data

  •   DRKS00006003
  •   2014/04/17
  •   [---]*
  •   yes
  •   Approved
  •   344/12, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

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Health Condition or Problem studied

  •   R54 -  Senility
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Interventions/Observational Groups

  •   U1: Initial examination with control of inclusion criteriae. 3 Month intervention period with strength training (3 times 60 min/week) with daily ingestion of 15 g collagen hydrolysate.
    U-2: Examination following the 3 month training period (in the morning after overnight fast) comparable with U1.
  •   U1: Initial examination with control of inclusion criteriae. 3 Month intervention period with strength training (3 times/week) with daily ingestion of placebo.
    U-2: Examination following the 3 month training period comparable with U1 (in the morning after overnight fast).
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, investigator/therapist, caregiver, assessor, data analyst
  •   Placebo
  •   Prevention
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Increase in muscle mass (lean body mass) following the 3 month strength training period using DEXA-measurements (compared to the pre-training status)

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Secondary Outcome

Increase in muscular power (isokinetic measurements) and
improvement in postural control (Posturomed) follwoing the 3 month strenght training

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2013/02/17
  •   60
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Male
  •   65   Years
  •   90   Years
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Additional Inclusion Criteria

2x 30 healthy subjects aged > 65 years with sarcopenia class I or II (1/2 SD below the normal values of a young reference pooulation in a handgrip test).
Ability to perform 1.25 Watt/kg bodyweight on a clycle ergometer without symptoms.
stable weight and nutritional behaviour.
No regular sports activity in the past (less that 1 h/week)
No contraindications regarding sports activities according to the criteriae of the ACSM
No contraindications againts supplememts.

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Exclusion Criteria

contraindications regarding sports activities according to the criteriae of the ACSM, 2009.
Diagnosis of cancer within the last 5 years.
Allergy/aversion against animal protein
Inability to perform a strenght training
Arterial hypertension (RRsyst > 200 mmHg und/oder RRdiast > 105 mmHg) under resting conditions;
Insulin dependant Diabetes mellitus type II
Liver oder kidnes disease with a non-permission to ingest higher concentraions of protein.

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Universitätsklinik Freiburg Bewegungsmedizin und Sport
    • Mr.  Prof. Dr. med.  Daniel  König 
    • Hugstetterstr. 55
    • 79106  Freiburg
    • Germany
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    • Universitätsklinik Freiburg Bewegungsmedizin und Sport
    • Mr.  Prof. Dr. med.  Daniel  König 
    • Hugstetterstr. 55
    • 79106  Freiburg
    • Germany
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    • Universitätsklinik Freiburg Bewegungsmedizin und Sport
    • Mr.  Prof. Dr. med.  Daniel  König 
    • Hugstetterstr. 55
    • 79106  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • GELITA AG
    • Mr.  Dr.  Hans-Christoph  Kneféli 
    • Uferstraße 7
    • 69412   Eberbach
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2013/11/11
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.