|- candidate number||22425|
|- NTR Number||NTR5294|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||8-jul-2015|
|- Secondary IDs||METC 15-30-19 |
|- Public Title||Pre-operative protein feeding to stimulate muscle and bone synthesis in older patients undergoing elective hip surgery|
|- Scientific Title||Pre-operative protein feeding to stimulate muscle and bone synthesis in older patients undergoing elective hip surgery|
|- hypothesis||Protein feeding prior to surgery enhances muscle and bone protein synthesis rates in the post-prandial period when compared to the non-feeding condition in older patients undergoing total hip arthroplasty.|
|- Healt Condition(s) or Problem(s) studied||Sarcopenia, Preoperative nutrition, Elective hip surgery, Muscle atrofy|
|- Inclusion criteria||1. Patients scheduled for total hip arthroplasty;|
2. 60-85 years;
3. BMI: 18.5-35 kg/m^2;
4. Functioning gastrointestinal tract, eligible for tube feeding via an intestinal tube.
|- Exclusion criteria||1. Co-morbidities and neuromuscular disorders of the lower limbs severely interacting with mobility;|
2. Co-morbidities severely interacting with muscle metabolism of the lower limbs;
3. Known renal malfunction (Known renal malfunction without documented approval from nephrologist);
4. Known allergy to milk, milk products and soy;
5. Known galactosaemia;
6. Known gastrointestinal medical history.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-aug-2015|
|- planned closingdate||31-jul-2016|
|- Target number of participants||24|
|- Interventions||1. This study will be conducted in older patients attending the department of Orthopedics with a scheduled total hip arthroplasty. |
2. Subjects are randomized into a feeding and non-feeding group (no intervention).
3. Continuous stable isotope infusions will be applied in both groups to measure muscle and bone protein synthesis rates.
4. Subjects in the feeding group will receive a protein-rich supplement via enteral administration prior to surgery.
5. During the pre- and perioperative period, 6 venous bloodsamples, a muscle biopsy and bone sample will be taken to measure turnover rates.
|- Primary outcome||The primary outcome is muscle and bone protein synthesis expressed as fractional synthesis rates (FSR, %/h). Muscle and bone-protein bound, muscle and bone-tissue free and plasma amino acid enrichments will be measured to calculate precusor and product enrichments.|
|- Secondary outcome||- Total plasma amino acids|
- Plasma glucose
- Plasma insulin
- Plasma amino acid enrichments
- GI tolerance
- Liver, kidney and muscle function
|- Timepoints||Timepoints in this study:|
1. Evening prior to surgery: Informed consent, DEXA-scan, questionnaires, placement of naso-duodenal tube;
2. Morning prior to surgery: placement of two intravenous catheters, infusion of stable isotope amino acids, administration of protein-rich supplement, blood draws every hour, questionnaire.
3. Surgery: muscle and bone collection, blood draws every hour
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES|| Imre Kouw|
|- CONTACT for SCIENTIFIC QUERIES|| Imre Kouw|
|- Sponsor/Initiator ||Maastricht University Medical Center (MUMC+), TI Food & Nutrition|
(Source(s) of Monetary or Material Support)
|TI Food and Nutrition|
|- Brief summary||Aging is associated with a gradual loss of skeletal muscle mass and function, termed sarcopenia. Periods of hospitalization and immobilization can increase the rate of muscle loss. Dietary protein supplementation represents an effective strategy to preserve skeletal muscle mass by stimulating muscle protein synthesis. In line, we propose that pre-operative feeding forms an effective nutritional strategy to stimulate muscle protein synthesis during surgery and, as such, improves subsequent recovery. |
|- Main changes (audit trail)|
|- RECORD||8-jul-2015 - 19-aug-2015|