Immune-modulation Effects of an Arginine Rich Nutritional Supplement in Surgical Patients

Martin Angst

Status: Completed

Conditions: Immunity

Treatments: Dietary Supplement: An arginine rich nutritional supplement

Study type: Interventional

Funder types: Other

Identifiers

NCT01885728

27485

Details and patient eligibility

About

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.

Enrollment: 22 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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22 participants in 2 patient groups

Arginine rich nutritional supplement

Active Comparator group

Description:

237 ml of an arginine rich nutritional supplement 4 times a day for the five days preceding surgery.

Treatment:

Dietary Supplement: An arginine rich nutritional supplement

No nutritional supplement

No Intervention group

Description:

No specific nutritional requirements have to be met in this group.