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

M

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

  • Colon surgery for cancer
  • Patients ≥ 18 and ≤65 years of age
  • 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

  • Patients on immune-suppressant therapy within the last 6 months (e.g. azathioprine or cyclosporine)
  • Patients pretreated (6 months) or currently on chemotherapy for cancer
  • Patients on radiation therapy (within 6 months)
  • Patients on chronic medication with potential immune-modulatory effects (e.g. daily oral morphine-equivalent intake > 30 mg)
  • Patients with metastatic disease
  • Patients with active infectious disease (within 2 months)
  • Patients with significant metabolic disease (e.g. diabetes type I)
  • Patients with clinically significant organ dysfunction including renal and hepatic dysfunction
  • Patients with significant cardiovascular and respiratory comorbidities resulting in impaired function and frailty
  • Patients with autoimmune disease (e.g. lupus)
  • Patients with Hx of substance abuse (e.g., alcoholism, drug dependency)
  • Undernourished patients as indicated by a weight loss >10% during the last 6 months
  • Patients with galactosemia
  • Patients who had undergone previous major abdominal surgery
  • 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
  • Pregnancy
  • 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)

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.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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