Immunity
Conditions
Brief summary
The primary objective of this study is to characterize the immune-modulatory effects of arginine-rich nutritional supplements in patients undergoing surgery. Numerical and functional changes of all circulating immune cells will be assessed with mass cytometry.
Interventions
DIETARY_SUPPLEMENTAn arginine rich nutritional supplement
Impact is a nutritional supplement formulated with 18 grams of protein per serving and 24 essential nutrients including arginine.
Sponsors
Martin Angst
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Colon surgery for cancer 2. Patients ≥ 18 and ≤65 years of age 3. Patients willing and able to sign an informed consent form and Health Insurance and Portability Act (HIPAA) authorization and to comply with study procedures
Exclusion criteria
1. Patients on immune-suppressant therapy within the last 6 months (e.g. azathioprine or cyclosporine) 2. Patients pretreated (6 months) or currently on chemotherapy for cancer 3. Patients on radiation therapy (within 6 months) 4. Patients on chronic medication with potential immune-modulatory effects (e.g. daily oral morphine-equivalent intake \> 30 mg) 5. Patients with metastatic disease 6. Patients with active infectious disease (within 2 months) 7. Patients with significant metabolic disease (e.g. diabetes type I) 8. Patients with clinically significant organ dysfunction including renal and hepatic dysfunction 9. Patients with significant cardiovascular and respiratory comorbidities resulting in impaired function and frailty 10. Patients with autoimmune disease (e.g. lupus) 11. Patients with Hx of substance abuse (e.g., alcoholism, drug dependency) 12. Undernourished patients as indicated by a weight loss \>10% during the last 6 months 13. Patients with galactosemia 14. Patients who had undergone previous major abdominal surgery 15. Participation in another clinical trial of an investigational drug or device within the last 30 days prior to the first day of study that, in the investigator's opinion, would create increased risk to the participant or compromise the integrity or either study 16. Pregnancy 17. Other conditions compromising a participant's safety or the integrity of the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in fractional representation of myeloid-derived suppressor cells (MDSC) from baseline. | Base line (prior to 1st administration of arginine supplement), immediately prior to surgery, 24 hours, 72 hours and 120 hours after surgery. | The fraction of MDSCs will be quantified. |
| Functional status change of myeloid-derived suppressor cells (MDSC) from baseline. | Base line (prior to 1st administration of arginine supplement), immediately prior to surgery, 24 hours, 72 hours and 120 hours after surgery. | Intracellular phosphorylation events in MDSCs will be quantified. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Impact of surgery on clinical recovery using multiple clinical measures and a validated questionnaire. | Daily for duration of hospital stay, then every 3 days trough postoperative week 5. | Outcome measures include the 1) Surgical Recovery Scale, 2) Pain (11-point numerical pain rating scale), 3) Consumption of analgesic drugs. |
Other
| Measure | Time frame |
|---|---|
| Fractional and absolute expansion/contraction of cluster of differentiation 4 (CD4)+ and cluster of differentiation 8 (CD8)+ cells | Base line (prior to 1st administration of arginine supplement), immediately prior to surgery, 24 hours, 72 hours and 120 hours after surgery. |
| Capacity of cluster of differentiation 4 (CD4)+ and cluster of differentiation 8 (CD8)+ cells | Base line (prior to 1st administration of arginine supplement), immediately prior to surgery, 24 hours, 72 hours and 120 hours after surgery. |
| Functional status of cluster of differentiation 4 (CD4)+ and cluster of differentiation 8 (CD8)+ cells | Base line (prior to 1st administration of arginine supplement), immediately prior to surgery, 24 hours, 72 hours and 120 hours after surgery. |
| Functional potency of cluster of differentiation 4 (CD4)+ and cluster of differentiation 8 (CD8)+ cells | Base line (prior to 1st administration of arginine supplement), immediately prior to surgery, 24 hours, 72 hours and 120 hours after surgery. |
Countries
United States
Outcome results
None listed