Mediterranean Diet in PD STN DBS Patients (NCT07187739)
Overview
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clinical_trials_medi_0["Trial Details"]
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clinical_trials_medi_1["Scientific Rationale"]
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clinical_trials_medi_2["Post-DBS Weight Gain in Parkinsons Disease"]
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clinical_trials_medi_3["Mediterranean Diet as Therapeutic Intervention"]
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clinical_trials_medi_4["Study Design"]
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clinical_trials_medi_5["Intervention Protocol"]
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...Mediterranean Diet in PD STN DBS Patients (NCT07187739)
Overview
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This clinical trial evaluates whether adherence to a Mediterranean diet for three months following bilateral subthalamic nucleus (STN) deep brain stimulation surgery can help control body weight gain and improve body composition in Parkinson's disease patients. Conducted by researchers at [Ankara University](/institutions/ankara-university) (Turkey), the trial addresses a significant clinical gap: the metabolic complications that frequently follow STN deep brain stimulation (DBS) in PD patients["@nct"].
Trial Details
| Parameter | Value |
|-----------|-------|
| NCT Number | NCT07187739 |
| Official Title | Investigation of the Effect of the Mediterranean Diet on Nutritional Status in Parkinson's Patients Undergoing Bilateral Subthalamic Nucleus Deep Brain Stimulation |
| Status | Recruiting (verified 2025-10) |
| Phase | Not Applicable |
| Study Type | Interventional |
| Enrollment | 24 participants (estimated) |
| Study Design | Randomized, Parallel Assignment, No Masking |
| Start Date | September 25, 2025 (actual) |
| Primary Completion | March 2026 (estimated) |
| Completion Date | March 2026 (estimated) |
| Lead Sponsor | Ankara University |
| Principal Investigator | Nursena ERSOY SÖKE, MsC |
| Locations | Ankara Etlik City Hospital, Ankara, Turkey |
Scientific Rationale
Post-DBS Weight Gain in Parkinson's Disease
Bilateral subthalamic nucleus deep brain stimulation is a highly effective treatment for advanced [Parkinson's disease](/diseases/parkinsons-disease), particularly for patients experiencing motor fluctuations and dyskinesia despite optimal pharmacological therapy. However, a well-documented side effect is significant body weight gain following surgery[@guimaraes2009]. This weight gain occurs through several mechanisms:
- Increased food intake: Reduced motor symptoms and dyskinesia decreases the energy expenditure associated with PD motor symptoms
- Improved appetite: Motor symptom relief and reduced stress around eating leads to increased caloric consumption
- Decreased physical activity energy expenditure: Even though mobility improves, the reduction in hyperkinetic movements (dyskinesia) and rigidity lowers baseline energy expenditure
- Levodopa dose escalation: Weight gain is associated with increasing [levodopa](/therapeutics/levodopa) dosage, which can in turn worsen dyskinesia and contribute to metabolic syndrome
The ESPEN (European Society for Clinical Nutrition and Metabolism) guideline on clinical nutrition in neurology specifically recommends nutritional therapy for DBS patients to control post-operative weight gain and prevent metabolic disorders[@burgos2018].
Mediterranean Diet as Therapeutic Intervention
The Mediterranean diet is characterized by:
- Primary dietary fat: Olive oil (high in monounsaturated fatty acids and polyphenols)
- High vegetable consumption: Minimum 300-400 grams daily
- High fruit consumption: 450 grams fresh fruit or 300g fresh + 30g dried fruit daily
- White meat preference: Fish and poultry favored over red meat
- Regular fish intake: 450 grams weekly
- Legume consumption: 180 grams weekly
- Nut and seed intake: 30 grams daily
- Reduced processed foods: Avoidance of bakery products, sugary snacks, carbonated beverages
This dietary pattern has demonstrated beneficial effects on:
- Body weight and composition
- Cardiovascular health
- Inflammation reduction
- Cognitive function
- Neuroprotective effects through polyphenols and omega-3 fatty acids
Study Design
Intervention Protocol
The Mediterranean diet intervention begins at the time of DBS device activation (typically 2-4 weeks post-surgery) and continues for three months:
Dietary Recommendations Include:
- Olive oil as the primary dietary fat source
- Minimum 300-400 grams of vegetables daily
- 450 grams of fresh fruit daily (or 300g fresh + 30g dried fruit)
- 450 grams of fish weekly
- 180 grams of legumes weekly
- 30 grams of oilseeds/nuts daily
- White meat (fish, poultry) preferred over red meat
- Discouraged: bakery products, sugary snacks, carbonated beverages
Follow-up Structure:
- Nutritional training at enrollment
- Monthly reinforcement sessions at 1st, 2nd, and 3rd month follow-ups
- Adherence monitored via the Mediterranean Diet Adherence Scale (14-item questionnaire)
Control Group
The control group continues their routine/usual diet without specific dietary guidance. This allows researchers to isolate the effect of the Mediterranean diet intervention from natural post-DBS dietary changes.
Assessment Timeline
| Timepoint | Assessments |
|-----------|-------------|
| Baseline (pre-operative) | Anthropometrics, body composition, appetite, QoL, motor symptoms, dietary recall |
| 1-month post-operative | All measures + 3-day food record |
| 2-month post-operative | All measures + 3-day food record |
| 3-month post-operative | All measures + 3-day food record + Mediterranean Diet Adherence Scale |
Outcome Measures
Primary Outcomes
| Measure | Description |
|---------|-------------|
| Body Weight | Measured with body analyzer sensitive to 0.1 kg |
| Height | Measured in cm with portable stadiometer (Frankfort plane position) |
| Body Mass Index | BMI calculated as weight (kg) / height squared (m²) |
Secondary Outcomes
| Measure | Description |
|---------|-------------|
| Triceps Skinfold Thickness | Caliper measurement in mm for adipose tissue assessment |
| Upper Mid-arm Circumference | Non-stretchable tape measure in cm |
| Upper Mid-arm Muscle Circumference | Calculated from arm circumference and triceps skinfold |
| Upper Mid-arm Muscle Area | Calculated in cm² for lean body mass assessment |
| Motor Symptoms (Nutrition) | MDS-UPDRS Part 2 sections 2.2 (chewing/swallowing) and 2.4 (eating) — 5-point Likert scale |
| Dietary Intake | 24-hour dietary recall + 3-day food consumption records analyzed via Nutrition Information System (BEBIS) |
| Quality of Life | PDQ-8 (Parkinson's Disease Questionnaire-8), 5-point Likert scale, converted to 0-100 score |
| Appetite Status | 100 mm Visual Analogue Scale (anchored: "very poor" to "very good") |
| Mediterranean Diet Adherence | 14-item Mediterranean Diet Adherence Scale (score ≥7 indicates acceptable compliance) |
Eligibility Criteria
Inclusion Criteria
- Age between 45 and 64 years
- Signed informed consent
- Undergoing bilateral STN DBS surgery
- Continuing antiparkinsonian medication therapy
- Mini-Mental State Examination (MMSE) score ≥ 24
Exclusion Criteria
- Psychiatric illness
- MMSE score < 24 (cognitive impairment)
- Disease requiring a special diet other than Parkinson's disease
Study Population
Participants are randomized into intervention and control groups stratified by age, gender, disease severity (Hoehn & Yahr stage), and body mass index. No healthy volunteers are included.
Mechanism of Action: Why Mediterranean Diet After STN DBS?
Addressing Post-Surgical Weight Gain
Post-STN DBS weight gain is multifactorial. The Mediterranean diet intervention targets several pathways:
Satiety Enhancement: High fiber content from vegetables, legumes, and whole grains promotes satiety, helping control overall caloric intake despite improved appetite
Metabolic Regulation: Monounsaturated fatty acids from olive oil improve insulin sensitivity and metabolic health, counteracting the tendency toward metabolic syndrome
Anti-inflammatory Effects: Mediterranean diet reduces systemic inflammation, which may benefit [neuroinflammation](/mechanisms/neuroinflammation) in Parkinson's disease
Neuroprotective Compounds: Polyphenols, omega-3 fatty acids, and antioxidants may provide additional benefit for dopaminergic neuron survivalConnection to Parkinson Disease Pathology
The Mediterranean diet may influence multiple pathways relevant to PD:
- Oxidative stress: Antioxidants from olive oil, vegetables, and fruits reduce oxidative damage to neurons
- Neuroinflammation: Omega-3 fatty acids and polyphenols modulate microglial activation and peripheral inflammation
- Gut-brain axis: The Mediterranean diet positively modulates gut microbiome composition, which is increasingly recognized as relevant to [Parkinson's disease](/diseases/parkinsons-disease) pathogenesis
- Mitochondrial function: Certain Mediterranean diet components support mitochondrial biogenesis and function
Connection to Deep Brain Stimulation Weight Management
Clinical Significance
STN DBS is one of the most effective surgical treatments for advanced [Parkinson's disease](/diseases/parkinsons-disease), with studies demonstrating significant improvements in motor symptoms, quality of life, and medication requirements. However, the post-operative weight gain creates a paradox: improved mobility comes with increased metabolic risk.
The trial directly addresses this gap by applying evidence-based nutritional intervention. If successful, the Mediterranean diet approach could become standard post-DBS care.
Nutritional Monitoring After DBS
The study uses comprehensive nutritional assessment tools:
- Anthropometric measurements (weight, height, BMI, circumferences, skinfolds)
- Body composition analysis
- Dietary intake assessment via 24-hour recalls and food records
- Validated appetite and adherence scales
Related Pages
- [Parkinson's Disease](/diseases/parkinsons-disease)
- [Deep Brain Stimulation for Parkinson's](/mechanisms/deep-brain-stimulation-parkinsons)
- [Subthalamic Nucleus](cell-types/subthalamic-nucleus)
- [Mediterranean Diet and Neurodegeneration](/therapeutics/mediterranean-diet-neurodegeneration)
- [Nutritional Approaches to Neurodegeneration](/therapeutics/nutritional-approaches)
- [Weight Management in Parkinson's Disease](/therapeutics/weight-management-parkinsons)
- [Levodopa-Induced Dyskinesia](/mechanisms/levodopa-induced-dyskinesia)
- [Ankara University](/institutions/ankara-university)
External Links
- [ClinicalTrials.gov — NCT07187739](https://clinicaltrials.gov/study/NCT07187739)
- [Ankara University](https://www.ankara.edu.tr)
- [Ankara Etlik City Hospital](https://www.sb.gov.tr)
References
[Burgos R, et al., ESPEN guideline clinical nutrition in neurology (2018)](https://pubmed.ncbi.nlm.nih.gov/29274834/)
[Guimaraes J, et al., Modulation of nutritional state in Parkinsonian patients with bilateral subthalamic nucleus stimulation (2009)](https://pubmed.ncbi.nlm.nih.gov/19633906/)
[NCT07187739 — Effect of Mediterranean Diet on Nutrition in Parkinson's Disease Patients With Bilateral Subthalamic Deep Brain Stimulation](https://clinicaltrials.gov/study/NCT07187739)