Oral Protein Supplementation Following Non-bariatric Surgery

NCT02622698 | Completed

• 1 other identifier: 356154
• Study Type: interventional
• Target: 62
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Protein Supplementation

Outcome Measures

Primary Outcomes (1)

• Change in weight

  Mean preoperative weight compared to mean postoperative weight at each follow-up appointment. Weight recorded in pounds, subsequent measurements at each postoperative point were normalized to the preoperative weight and reported as a relative percentage of the preoperative weight.

  Preoperative, and then postoperative at 1-2 weeks, 3 weeks, 1 month, 2 months, 3 months, 6 months

Secondary Outcomes (5)

• Wound healing

  Preoperative, and then postoperative at 1-2 weeks, 3 weeks, 1 month, 2 months, 3 months, 6 months

• Change in white blood cell count (1x10 3/ uL)

  Preoperative, and then postoperative at 1-2 weeks, 3 weeks, 1 month, 2 months, 3 months, 6 months

• Change in total protein (g/ dL)

  Preoperative, and then postoperative at 1-2 weeks, 3 weeks, 1 month, 2 months, 3 months, 6 months

• Change in albumin (g/ dL)

  Preoperative, and then postoperative at 1-2 weeks, 3 weeks, 1 month, 2 months, 3 months, 6 months

• Change in prealbumin (mg/ dL)

  Preoperative, and then postoperative at 1-2 weeks, 3 weeks, 1 month, 2 months, 3 months, 6 months

Study Arms (2)

Control

PLACEBO COMPARATOR

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

Other: Placebo

Treatment

EXPERIMENTAL

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.

Dietary Supplement: Prostat AWC

Interventions

Prostat AWC DIETARY_SUPPLEMENT

Prostat AWC- patients received protein supplementation after surgery

Treatment

Placebo OTHER

Placebo- Patients did not take any protein supplementation after surgery

Also known as: No intervention

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Eisenhower Army Medical Center: lead
• Medical Nutrition USA, Inc.: collaborator

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Christina Riojas, General Surgeon

Study Record Dates

• First Submitted: December 1, 2015
• First Posted: December 4, 2015
• Study Start: August 1, 2011
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: December 4, 2015

Record last verified: 2015-12