Clinical trial · Interventional
Oral Versus Parenteral Nutrition Support to Improve Protein Balance in Colorectal Surgical Patients
Oral Versus Parenteral Perioperative Nutrition Support to Improve Protein Balance: Stable Isotope Study in Colorectal Surgical Patients
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
A prospective, randomized controlled study, using stable isotope methodology, is proposed to determine whether an oral nutrition support regimen, containing pressurized whey protein and glucose, is more effective at normalizing the metabolic response to surgery than a standard peripheral parenteral nutrition (PPN) support regimen, containing amino acids and glucose, in colorectal surgical patients studied before and after surgery. The effectiveness of the nutrition support regimens will be determined by: whole body protein balance, synthesis rates of hepatic secretory proteins, resting energy expenditure and substrate utilization, as well as circulating metabolites concentrations.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colon Cancer | Malignant Colon Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Oral Nutrition with dextrose and pressurized whey protein | Dietary Supplement | — | UNRESOLVED |
| Peripheral Parenteral Nutrition | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Oral Nutrition
- description
- Subjects will receive an oral nutrition regimen comprised of 50% of their Resting Energy Expenditure (REE) as dextrose and 20% of their REE as pressurized whey protein
- interventionNames
- Dietary Supplement: Oral Nutrition with dextrose and pressurized whey protein
- type
- PLACEBO_COMPARATOR
- label
- Peripheral Parenteral Nutrition
- description
- Subjects will receive a peripheral parenteral nutrition (PPN) regimen comprised of 50% of their Resting Energy Expenditure (REE) as dextrose and 20% of their REE as amino acids.
- interventionNames
- Dietary Supplement: Peripheral Parenteral Nutrition
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: 1. The American Society of Anesthesiologists' (ASA) class 1 to 3 2. Colorectal surgery for non-metastatic disease (including right, transverse, left, sigmoid, subtotal, total, and hemicolectomy) 3. Nutrition status: 18.5 \< body mass index \< 30 kg/m2, stable weight over the preceding three months (\< 10% body weight loss), serum albumin \> 35g/l Exclusion Criteria: 1. History of hepatic failure (Child-Pugh score A-C and transaminases outside the normal range) 2. Renal impairment (Serum Creatinine outside normal range) 3. Cardiac failure (New York Heart Association (NYHA) classes I-IV) 4. Hepatic, Renal, Cardiac transplant 5. Endocrine disorders: diabetes type I \& II, hyper and hypothyroidism 6. Active inflammatory bowel or diverticular disease (Crohn's Disease, Ulcerative Colitis) 7. Musculoskeletal or neuromuscular disease 8. Anemia defined as hematocrit \< 30, hemoglobin \< 10 g/dl, albumin \< 25 mg/dl 9. Previous spine surgery or scoliosis limiting use of epidural 10. Pregnancy 11. Use of Steroids 12. Milk protein allergy or intolerance
References
Publications (1)
- RESULTSchricker T, Meterissian S, Lattermann R, Adegoke OA, Marliss EB, Mazza L, Eberhart L, Carli F, Nitschman E, Wykes L. Anticatabolic effects of avoiding preoperative fasting by intravenous hypocaloric nutrition: a randomized clinical trial. Ann Surg. 2008 Dec;248(6):1051-9. doi: 10.1097/SLA.0b013e31818842d8. PMID 19092350