Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effect of Protein Supplement on Paraspinal Muscles in Spine Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04300517
Recruitment Status : Completed
First Posted : March 9, 2020
Last Update Posted : July 28, 2020
Sponsor:
Information provided by (Responsible Party):
Zahra Vahdat Shariatpanahi, Shahid Beheshti University

Brief Summary:

Protein intake in spinal fusion surgery can prevent paraspinal muscle atrophy by maintaining muscle mass, regeneration, and growth. Also, by reducing the amount of pseudarthrosis, pain and disability can have a positive effect on recovery.

The high prevalence of this type of surgery, the instability and degeneration of adjacent surfaces of fused sections, lumbar muscle atrophy, increased muscle tissue fat, and negative impact on patient recovery, also with regard to the fact that research has so far aimed to determine The effect of protein supplementation on para-spinal muscles has not been studied in patients undergoing posterior lumbar spine fusion surgery, therefore clinical trials are necessary. In this trial patients undergoing elective posterior spine fusion surgery are divided into two groups of intervention or control.


Condition or disease Intervention/treatment Phase
Spine Surgery Drug: Three sachet of protein supplement to be mixed in with water used daily Not Applicable

Detailed Description:
A randomized, double blind, controlled trial will be conducted in patients undergoing elective posterior spine fusion surgery in Tehran, Iran. After a full review of the inclusion and exclusion criteria and explanation of the risks and benefits of the study, written consent form will be completed. The participants are 80 eligible posterior spine fusion surgery patients, aged ≥ 18 years. Intervention patients will be received 36 grams of protein supplement along with diet containing 1.2 g/kg/day of protein for 30 days after surgery and control patients will be received maltodextrin along with diet containing 1.2 g/kg/day of protein 30 days after surgery. Patients will be evaluated for occurrence of paraspinal muscles after 3 months surgery

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Effect of Protein Supplement on Paraspinal Muscles in Patients Undergoing Lumbar Posterior Spine Fusion Surgery
Actual Study Start Date : February 1, 2020
Actual Primary Completion Date : July 1, 2020
Actual Study Completion Date : July 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: protein supplement
Intervention patients will be received protein diet (1.2 g/kg/day) and protein supplement (36 g/day) for 1 month after surgery.
Drug: Three sachet of protein supplement to be mixed in with water used daily
Three sachet of protein supplement to be mixed in with water used daily
Other Name: Pure-protein®

Placebo Comparator: maltodextrin
Control patients will be received protein diet (1.2 g/kg/day) and maltodextrin for 1 month after surgery.
Drug: Three sachet of protein supplement to be mixed in with water used daily
Three sachet of protein supplement to be mixed in with water used daily
Other Name: Pure-protein®




Primary Outcome Measures :
  1. The thickness of the paraspinal muscles in CT scan [ Time Frame: 3 months after surgery ]
    The thickness of the paraspinal muscles (multifidus, erector spinae, Quadratus, and Lumborum) in CT scan


Secondary Outcome Measures :
  1. Degree and severity of paraspinal muscle mass atrophy in CT scan [ Time Frame: baseline, and 3 months after surgery ]
    Degree and severity of paraspinal muscle mass atrophy (multifidus, erector spinae, Quadratus, and Lumborum) in CT scan



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patients 18-65 years
  • Body mass index 18.5-30
  • Candidate for the elective posterior spine fusion
  • Without history of severe liver disorder
  • Without history of Kidney disorder
  • Without history of diabetes
  • Without history of trauma and fracture of the vertebral
  • Without history of osteoporosis
  • Without history of Gastrointestinal malabsorption
  • Without history of Parathyroid gland disorders
  • Without taking medications that affect the metabolism of bone, such as calcitonin, bisphosphonate, corticosteroid
  • No smoking
  • Without history of neuromuscular diseases such as dystrophies and neurological disorders

Exclusion Criteria:

  • Allergy or intolerance to protein or maltodextrine supplement
  • Unwillingness to continue cooperation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04300517


Locations
Layout table for location information
Iran, Islamic Republic of
Faculty of Nutrition and Food Technology, Shahid Beheshti University of Medical Sciences, Shohada Tajrish Hospital
Tehran, Iran, Islamic Republic of
Sponsors and Collaborators
Shahid Beheshti University
Layout table for additonal information
Responsible Party: Zahra Vahdat Shariatpanahi, Principal Investigator, Shahid Beheshti University
ClinicalTrials.gov Identifier: NCT04300517    
Other Study ID Numbers: 1398/802
First Posted: March 9, 2020    Key Record Dates
Last Update Posted: July 28, 2020
Last Verified: July 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Zahra Vahdat Shariatpanahi, Shahid Beheshti University:
Protein supplement
Spine Surgery
Paraspinal Muscles