Effect of Protein Supplement on Paraspinal Muscles in Spine Surgery

NCT04300517 | Completed DMC

• 1 other identifier: 1398/802
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Spine Surgery

Keywords

Protein supplement; Spine Surgery; Paraspinal Muscles

Outcome Measures

Primary Outcomes (1)

• The thickness of the paraspinal muscles in CT scan

  The thickness of the paraspinal muscles (multifidus, erector spinae, Quadratus, and Lumborum) in CT scan

  3 months after surgery

Secondary Outcomes (1)

• Degree and severity of paraspinal muscle mass atrophy in CT scan

  baseline, and 3 months after surgery

Study Arms (2)

protein supplement

EXPERIMENTAL

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

maltodextrin

PLACEBO COMPARATOR

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

Interventions

Three sachet of protein supplement to be mixed in with water used daily DRUG

Three sachet of protein supplement to be mixed in with water used daily

Also known as: Pure-protein®

maltodextrin; protein supplement

Eligibility Criteria

• Age: 18 Years - 65 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Shahid Beheshti University: lead

Study Sites (1)

Faculty of Nutrition and Food Technology, Shahid Beheshti University of Medical Sciences, Shohada Tajrish Hospital

Tehran, Iran

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 3, 2020
• First Posted: March 9, 2020
• Study Start: February 1, 2020
• Primary Completion: July 1, 2020
• Study Completion: July 1, 2020
• Last Updated: July 28, 2020

Record last verified: 2020-07

Locations

IR (1)