Oral Protein Supplementation Following Non-bariatric Surgery

Eisenhower Army Medical Center

Status: Completed

Conditions: Protein Supplementation

Treatments: Dietary Supplement: Prostat AWC; Other: Placebo

Study type: Interventional

Funder types: Other U.S. Federal agency; Industry

Identifiers

NCT02622698

356154

Details and patient eligibility

About

Investigators performed a randomized controlled trial of 62 patients undergoing elective abdominal operations. The treatment group was provided a liquid protein supplement and instructed to take a dose three times daily for the first 20 postoperative days. Investigators followed patients for six months and compared wound healing and changes in weight and laboratory values.

Enrollment: 62 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• patients scheduled to undergo abdominal surgery [cholecystectomy, ventral hernia repair, colectomy, non-bariatric gastric surgery, appendectomy, small bowel resection, lysis of adhesions, liver resection, splenectomy, proctectomy, stoma construction, pancreatic surgery, duodenal surgery, adrenal surgery, renal surgery, or cystectomy]

Exclusion criteria

• Age less than 18 years
• Pregnant
• Abdominal surgery within the past 6 months
• Inability to attend follow-up appointments for at least 6 months
• Liver failure (Child-Pugh Class B or C) or kidney failure (glomerular filtration rate (GFR) less than 30).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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62 participants in 2 patient groups, including a placebo group

Control

Placebo Comparator group

Description:

The patients in the control group did not receive any supplementation, and were directed to follow the dietary guidelines of their surgeon.

Treatment:

Other: Placebo

Treatment

Experimental group

Description:

Patients were instructed to consume one ounce (containing 16 grams of protein) of the supplement three times daily. No other modifications were made to the patient's diet. Patients were provided with a total of 60 doses, which would last 20 days if they consumed each dose as instructed.

Treatment:

Dietary Supplement: Prostat AWC