Trial document
This trial has been registered retrospectively.
DRKS00006003
Trial Description
Title
Influence of collagen hydrolysate on muscle mass in subjects with sarcopenia
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.
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.
Organizational Data
- DRKS00006003
- 2014/04/17
- [---]*
- yes
- Approved
- 344/12, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
Secondary IDs
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Health Condition or Problem studied
- R54 - Senility
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).
Characteristics
- Interventional
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- Randomized controlled trial
- Blinded
- patient/subject, investigator/therapist, caregiver, assessor, data analyst
- Placebo
- Prevention
- Parallel
- N/A
- N/A
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)
Secondary Outcome
Increase in muscular power (isokinetic measurements) and
improvement in postural control (Posturomed) follwoing the 3 month strenght training
Countries of Recruitment
- Germany
Locations of Recruitment
- Medical Center
Recruitment
- Actual
- 2013/02/17
- 60
- Monocenter trial
- National
Inclusion Criteria
- Male
- 65 Years
- 90 Years
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.
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.
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
end of 1:1-Block address primary-sponsorstart of 1:1-Block address contact primary-sponsor- 004976127074950
- 004976127074700
- Daniel.Koenig at uniklinik-freiburg.de
- http://www.uniklinik-freiburg.de
end of 1:1-Block address contact primary-sponsor -
start of 1:1-Block address scientific-contact
- Universitätsklinik Freiburg Bewegungsmedizin und Sport
- Mr. Prof. Dr. med. Daniel König
- Hugstetterstr. 55
- 79106 Freiburg
- Germany
end of 1:1-Block address scientific-contactstart of 1:1-Block address contact scientific-contact- 004976127074950
- 004976127074700
- Daniel.Koenig at uniklinik-freiburg.de
- http://www.uniklinik-freiburg.de
end of 1:1-Block address contact scientific-contact -
start of 1:1-Block address public-contact
- Universitätsklinik Freiburg Bewegungsmedizin und Sport
- Mr. Prof. Dr. med. Daniel König
- Hugstetterstr. 55
- 79106 Freiburg
- Germany
end of 1:1-Block address public-contactstart of 1:1-Block address contact public-contact- 004976127074950
- 004976127074700
- Daniel.Koenig at uniklinik-freiburg.de
- http://www.uniklinik-freiburg.de
end of 1:1-Block address contact public-contact
Sources of Monetary or Material Support
-
start of 1:1-Block address materialSupport
- GELITA AG
- Mr. Dr. Hans-Christoph Kneféli
- Uferstraße 7
- 69412 Eberbach
- Germany
end of 1:1-Block address materialSupportstart of 1:1-Block address contact materialSupport- 0049 (0)6271 84 2551
- 0049 (0)6271 84 4551
- Hans-Christoph.Knefeli at gelita.com
- http://www.gelita.de
end of 1:1-Block address contact materialSupport
Status
- Recruiting complete, follow-up complete
- 2013/11/11
Trial Publications, Results and other Documents
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