Lumbar DiscectomyNCT07918729
Effects of an Anti-Inflammatory Diet on Inflammatory and Neuroendocrine Responses After Lumbar Discectomy
A study testing Anti-inflammatory Dietary Intervention and Standart Dietary Counseling in people with Lumbar Discectomy, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
This study was aimed to investigate the effects of pre-operative nutritional status and post-operative dietary interventions on inflammation, pain, and recovery in adults undergoing lumbar disc surgery. Read more about this study
- Who is it for?
- Ages 19 to 64 years
- Conditions the study is for
- Lumbar Discectomy
- What is being tested?
- Anti-inflammatory Dietary Intervention and Standart Dietary Counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2025to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 19 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients scheduled to undergo primary single-level lumbar discectomy aged 19-64 years.
Who cannot join
- History of malignancy or neuroendocrine tumors.
- Presence of chronic inflammatory or autoimmune diseases (e.g., rheumatoid arthritis or inflammatory bowel disease).
- Active infection.
- Gastrointestinal diseases.
- Metabolic diseases.
- Undergoing multilevel spinal surgery.
- Pregnancy or lactation.
- Use of medications that may affect chromogranin A (CgA) levels or inflammatory responses, including high-dose corticosteroids and proton pump inhibitors (e.g., omeprazole).
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Sivas Cumhuriyet University Faculty of Medicine, Department of Neurosurgery
Sivas
About this study
Official title: Effects of a Postoperative Anti-inflammatory Dietary Intervention on Neuroendocrine and Inflammatory Biomarkers After Lumbar Discectomy
This study was aimed to investigate the effects of pre-operative nutritional status and post-operative dietary interventions on inflammation, pain, and recovery in adults undergoing lumbar disc surgery.
Participants were planned to undergo nutritional assessment before surgery and receive either an individualized anti-inflammatory diet or a standard balanced diet after surgery. Dietary intake was monitored over a four-week postoperative period.
Read more
The study evaluated whether an anti-inflammatory dietary intervention can reduce postoperative inflammation, pain, and complications compared with a standard diet. It also examined the relationship between pre-operative nutritional status and post-operative recovery of the patients.
The findings may help improve nutritional assessment and dietary management in patients undergoing lumbar disc surgery.
Read the detailed description
This prospective, randomized controlled dietary intervention study is conducted at the Department of Neurosurgery, Sivas Cumhuriyet University Faculty of Medicine, Türkiye. The study includes adult patients aged 19-64 years undergoing lumbar disc surgery, with a planned sample size of 80 participants. Following the discharge decision, participants are randomly assigned to one of two parallel groups: an individualized anti-inflammatory diet group (n=40) or a standard diet group (n=40). Surgical procedures are standardized by using the same surgical approach and physician.
We assess preoperative nutritional status to identify malnutrition risk and investigate its association with postoperative inflammatory responses and clinical outcomes. Nutritional and inflammatory status are further evaluated using the Glasgow Prognostic Score (GPS) and Prognostic Nutritional Index (PNI). We also examine the relationship between preoperative fasting duration and postoperative stress responses.
Following random group allocation, participants receive individualized dietary counseling according to their age, body weight, and estimated energy requirements. The standard diet group received counseling based on general healthy eating principles, while the anti-inflammatory diet group received an individualized dietary program based on the Mediterranean dietary pattern, with a target macronutrient distribution of 40% carbohydrate, 30% protein, and 30% fat. Energy requirements are estimated using weight-based equations adjusted for age, sex, and physical activity level.
Dietary intake and adherence are monitored using weekly three-day food records throughout the four-week postoperative period.
Postoperative inflammatory and stress responses are assessed using biochemical parameters, including interleukin-6 (IL-6) and chromogranin A (CgA). Associations between these biomarkers, postoperative pain, nutritional status, and clinical recovery are investigated. The study also compares postoperative inflammatory responses and clinical outcomes between the two dietary intervention groups.
The primary hypothesis is that an anti-inflammatory dietary intervention may attenuate postoperative inflammation and improve recovery compared with a standard diet. Additional analyses examine whether preoperative malnutrition risk, nutritional prognostic indices, and fasting duration are associated with postoperative inflammatory responses and complications.
The study was aimed to provide evidence regarding the role of perioperative nutritional assessment and dietary interventions in improving postoperative outcomes following lumbar disc surgery.
- Conditions
- Lumbar Discectomy
- Being tested
- Anti-inflammatory Dietary Intervention, Standart Dietary Counseling
- Keywords
- postoperative recovery, anti-inflammatory diet, Lumbar discectomy, perioperative nutrition, chromogranin A, inflammatory biomarkers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti-inflammatory Dietary InterventionBehavioural
Participants received individualized dietary counseling following lumbar discectomy, focusing on an anti-inflammatory dietary pattern rich in vegetables, fruits, whole grains, omega-3 fatty acids, and other foods with anti-inflammatory properties. Dietary plans were tailored to individual energy requirements. Dietary adherence was monitored using weekly three-day food records over a four-week postoperative period.
Standart Dietary CounselingBehavioural
Participants in the standard dietary intervention group received individualized dietary counseling following lumbar discectomy, based on general principles of healthy and balanced nutrition.
| Study group | Role | What they receive |
|---|---|---|
| Anti-inflammatory diet | Experimental | 40 patients Receives: Behavioral: Anti-inflammatory Dietary Intervention |
| Standart Diet | Active comparator | 40 patients Receives: Behavioral: Standart Dietary Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Chromogranin A (CgA) Levels
Changes in chromogranin A (CgA) concentrations will be assessed as a marker of the physiological stress response following lumbar disc surgery. CgA levels will be compared between the anti-inflammatory diet and standard diet groups to investigate the potential effects of dietary intervention on postoperative stress responses.
Measured: Before surgery, after surgery, and 4 weeks after initiation of the dietary intervention.
Secondary outcomes (2)
Change in Interleukin-6 (IL-6) Levels
Changes in serum interleukin-6 (IL-6) concentrations will be assessed as an indicator of the acute inflammatory response to lumbar disc surgery. IL-6 levels will be compared between the anti-inflammatory diet and standard diet groups to evaluate the effect of postoperative dietary intervention on inflammation.
Measured: Before surgery, after surgery, and 4 weeks after initiation of the dietary intervention.
Change in The Prognostic Nutritional Index
The Prognostic Nutritional Index (PNI) was used to evaluate preoperative nutritional and immunological status and its association with postoperative inflammatory responses and clinical outcomes. Lower PNI values indicate poorer nutritional and immunological status
Measured: Before surgery, after surgery, and 4 weeks after initiation of the dietary intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2026
- Study start1 Sep 2025
- Primary completion30 Jun 2026
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar DiscectomyStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Collaborators
- Cumhuriyet University
- Responsible party
- Principal investigator, Derya Dikmen, Hacettepe University
- Investigators
- Derya Dikmen, PhD, Professor, Principal investigator, Hacettepe UniversityÜnal Özüm, Medical Doctor, Professor, Principal investigator, Cumhuriyet University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07918729
- Sponsor's protocol ID
- 2025-06/39
- Status last verified
- Oct 2026
- First submitted
- 1 Nov 2026
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the results reported in the published article may be made available to qualified researchers upon reasonable request to the corresponding author, following publication.
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Postoperative Anti-inflammatory Dietary Intervention on Neuroendocrine and Inflammatory Biomarkers After Lumbar Discectomy
- ClinicalTrials.gov ID
- NCT07918729
- Acronym / sponsor ID
- 2025-06/39
- Conditions
- Lumbar Discectomy
- Keywords
- postoperative recovery, anti-inflammatory diet, Lumbar discectomy, perioperative nutrition, chromogranin A, inflammatory biomarkers
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Collaborators
- Cumhuriyet University
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 30 Jun 2026 (actual)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 5 Nov 2026 (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.
This study was aimed to investigate the effects of pre-operative nutritional status and post-operative dietary interventions on inflammation, pain, and recovery in adults undergoing lumbar disc surgery.
Participants were planned to undergo nutritional assessment before surgery and receive either an individualized anti-inflammatory diet or a standard balanced diet after surgery. Dietary intake was monitored over a four-week postoperative period.
The study evaluated whether an anti-inflammatory dietary intervention can reduce postoperative inflammation, pain, and complications compared with a standard diet. It also examined the relationship between pre-operative nutritional status and post-operative recovery of the patients.
The findings may help improve nutritional assessment and dietary management in patients undergoing lumbar disc surgery.
Detailed description
This prospective, randomized controlled dietary intervention study is conducted at the Department of Neurosurgery, Sivas Cumhuriyet University Faculty of Medicine, Türkiye. The study includes adult patients aged 19-64 years undergoing lumbar disc surgery, with a planned sample size of 80 participants. Following the discharge decision, participants are randomly assigned to one of two parallel groups: an individualized anti-inflammatory diet group (n=40) or a standard diet group (n=40). Surgical procedures are standardized by using the same surgical approach and physician.
We assess preoperative nutritional status to identify malnutrition risk and investigate its association with postoperative inflammatory responses and clinical outcomes. Nutritional and inflammatory status are further evaluated using the Glasgow Prognostic Score (GPS) and Prognostic Nutritional Index (PNI). We also examine the relationship between preoperative fasting duration and postoperative stress responses.
Following random group allocation, participants receive individualized dietary counseling according to their age, body weight, and estimated energy requirements. The standard diet group received counseling based on general healthy eating principles, while the anti-inflammatory diet group received an individualized dietary program based on the Mediterranean dietary pattern, with a target macronutrient distribution of 40% carbohydrate, 30% protein, and 30% fat. Energy requirements are estimated using weight-based equations adjusted for age, sex, and physical activity level.
Dietary intake and adherence are monitored using weekly three-day food records throughout the four-week postoperative period.
Postoperative inflammatory and stress responses are assessed using biochemical parameters, including interleukin-6 (IL-6) and chromogranin A (CgA). Associations between these biomarkers, postoperative pain, nutritional status, and clinical recovery are investigated. The study also compares postoperative inflammatory responses and clinical outcomes between the two dietary intervention groups.
The primary hypothesis is that an anti-inflammatory dietary intervention may attenuate postoperative inflammation and improve recovery compared with a standard diet. Additional analyses examine whether preoperative malnutrition risk, nutritional prognostic indices, and fasting duration are associated with postoperative inflammatory responses and complications.
The study was aimed to provide evidence regarding the role of perioperative nutritional assessment and dietary interventions in improving postoperative outcomes following lumbar disc surgery.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anti-inflammatory diet | Experimental | Behavioral: Anti-inflammatory Dietary Intervention40 patients |
| Standart Diet | Active comparator | Behavioral: Standart Dietary Counseling40 patients |
Who may qualify
- Ages
- 19 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients scheduled to undergo primary single-level lumbar discectomy aged 19-64 years.
Key exclusion criteria (8 listed)
- History of malignancy or neuroendocrine tumors.
- Presence of chronic inflammatory or autoimmune diseases (e.g., rheumatoid arthritis or inflammatory bowel disease).
- Active infection.
- Gastrointestinal diseases.
- Metabolic diseases.
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 |
|---|---|---|
| Anti-inflammatory Dietary InterventionParticipants received individualized dietary counseling following lumbar discectomy, focusing on an anti-inflammatory dietary pattern rich in vegetables, fruits, whole grains, omega-3 fatty acids, and other foods with anti-inflammatory properties. Dietary plans were tailored to individual energy requirements. Dietary adherence was monitored using weekly three-day food records over a four-week postoperative period. | Behavioural | Anti-inflammatory diet |
| Standart Dietary CounselingParticipants in the standard dietary intervention group received individualized dietary counseling following lumbar discectomy, based on general principles of healthy and balanced nutrition. | Behavioural | Standart Diet |
Primary outcome
Change in Chromogranin A (CgA) Levels
Time frame: Before surgery, after surgery, and 4 weeks after initiation of the dietary intervention.
Changes in chromogranin A (CgA) concentrations will be assessed as a marker of the physiological stress response following lumbar disc surgery. CgA levels will be compared between the anti-inflammatory diet and standard diet groups to investigate the potential effects of dietary intervention on postoperative stress responses.
2 secondary outcomes
Change in Interleukin-6 (IL-6) Levels
Time frame: Before surgery, after surgery, and 4 weeks after initiation of the dietary intervention.
Change in The Prognostic Nutritional Index
Time frame: Before surgery, after surgery, and 4 weeks after initiation of the dietary intervention.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the results reported in the published article may be made available to qualified researchers upon reasonable request to the corresponding author, following publication.
Related trials for Lumbar Discectomy
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Analgesia Following Lumbar Discectomy
Analgesia, Disk Herniated Lumbar
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Return to Activity After Surgery for Lumbar Disc Herniation
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Subjective Intraoperative Use of Epidural Steroid Administration Following Discectomy
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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.
Derya Dikmen, PhD, Professor principal investigator
Hacettepe University
Ünal Özüm, Medical Doctor, Professor principal investigator
Cumhuriyet University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anti-inflammatory Dietary Intervention and Standart Dietary Counseling in people with Lumbar Discectomy, run by Hacettepe University at 1 site in Turkey (Türkiye).
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 1 inclusion and 8 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: under way, not looking for participants, as of the sponsor's last update on 5 Nov 2026. 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 Turkey (Türkiye). 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. 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?
This study is still under way. Results are not available in the source record yet.
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?
Change in Chromogranin A (CgA) Levels (time frame: Before surgery, after surgery, and 4 weeks after initiation of the dietary intervention.). 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 5 Nov 2026.