Spine SurgeryNCT04300517
Effect of Protein Supplement on Paraspinal Muscles in Spine Surgery
A study testing Three sachet of protein supplement to be mixed in with water used daily in people with Spine Surgery, run by Shahid Beheshti University at 1 site in Iran.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Spine Surgery
- What is being tested?
- Three sachet of protein supplement to be mixed in with water used daily
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteIran
- Study dates
- 1 Feb 2020to 1 Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 13Show fewer
- 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
Who cannot join
- Allergy or intolerance to protein or maltodextrine supplement
- Unwillingness to continue cooperation
Trial locations and contacts
1 site in 1 country.
Iran1 site
Faculty of Nutrition and Food Technology, Shahid Beheshti University of Medical Sciences, Shohada Tajrish Hospital
Tehran
About this study
Official title: The Effect of Protein Supplement on Paraspinal Muscles in Patients Undergoing Lumbar Posterior Spine Fusion Surgery
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.
Read the 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
- Conditions
- Spine Surgery
- Being tested
- Three sachet of protein supplement to be mixed in with water used daily
- Keywords
- Protein supplement, Spine Surgery, Paraspinal Muscles
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Three sachet of protein supplement to be mixed in with water used dailyDrug
Also called Pure-protein®
Three sachet of protein supplement to be mixed in with water used daily
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Three sachet of protein supplement to be mixed in with water used daily |
What is being measured
The primary outcome is the main question the study is designed to answer.
The thickness of the paraspinal muscles in CT scan
The thickness of the paraspinal muscles (multifidus, erector spinae, Quadratus, and Lumborum) in CT scan
Measured: 3 months after surgery
Secondary outcomes (1)
Degree and severity of paraspinal muscle mass atrophy in CT scan
Degree and severity of paraspinal muscle mass atrophy (multifidus, erector spinae, Quadratus, and Lumborum) in CT scan
Measured: baseline, and 3 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2020
- Study start1 Feb 2020
- Primary completion1 Jul 2020
- Study completion1 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spine SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shahid Beheshti University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zahra Vahdat Shariatpanahi, Shahid Beheshti University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04300517
- Sponsor's protocol ID
- 1398/802
- Status last verified
- Jul 2020
- First submitted
- 3 Mar 2020
- Last updated
- 28 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Protein Supplement on Paraspinal Muscles in Patients Undergoing Lumbar Posterior Spine Fusion Surgery
- ClinicalTrials.gov ID
- NCT04300517
- Acronym / sponsor ID
- 1398/802
- Conditions
- Spine Surgery
- Keywords
- Protein supplement, Spine Surgery, Paraspinal Muscles
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Shahid Beheshti UniversityUniversity, hospital or other
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 1 Jul 2020 (actual)
- Study completion
- 1 Jul 2020 (actual)
- First posted
- 9 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| protein supplement | Experimental | Drug: Three sachet of protein supplement to be mixed in with water used dailyIntervention patients will be received protein diet (1.2 g/kg/day) and protein supplement (36 g/day) for 1 month after surgery. |
| maltodextrin | Placebo comparator | Drug: Three sachet of protein supplement to be mixed in with water used dailyControl patients will be received protein diet (1.2 g/kg/day) and maltodextrin for 1 month after surgery. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (2 listed)
- Allergy or intolerance to protein or maltodextrine supplement
- Unwillingness to continue cooperation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Three sachet of protein supplement to be mixed in with water used dailyAlso: Pure-protein®Three sachet of protein supplement to be mixed in with water used daily | Drug | maltodextrin, protein supplement |
Primary outcome
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
1 secondary outcome
Degree and severity of paraspinal muscle mass atrophy in CT scan
Time frame: baseline, and 3 months after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Three sachet of protein supplement to be mixed in with water used daily in people with Spine Surgery, run by Shahid Beheshti University at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The thickness of the paraspinal muscles in CT scan (time frame: 3 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2020.