Anti-inflammatory Nutritional Intervention in Patients With Fibromyalgia

Study Overview
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Brief Summary
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This is a randomized clinical trial, aimed to analyse the effects of a potentially anti-inflammatory nutritional intervention in disease assessment parameters, inflammatory markers, and quality of life of Fibromyalgia patients. Patients in the intervention group will adopt an anti-inflammatory diet and a diet with a low ingestion of fermentable oligo-, di- and monosaccharides, and polyols (FODMAPs), for a 3 months period. Group control will adopt a diet based on general recommendations for healthy eating in accordance with the World Health Organization.

Detailed Description
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The presence of low grade intestinal inflammation has been reported in Fibromyalgia (FM) patients. Other studies associate the persistence of symptoms described in FM to possible alterations of the intestinal microbiota composition, i.e. dysbiosis, with consequent existence of Small Intestinal Bacterial Overgrowth (SIBO). A sample of 100 female patients diagnosed with FM, followed-up at Portuguese Rheumathology Institute in Lisbon, will be distributed randomly in two groups. Group 1 will adopt an anti-inflammatory diet, which is characterized by the exemption of the intake of potentially inflammatory foods, namely gluten, dairy and ultra-processed foods, over a consecutive period of 3 months. During the first month, a low FODMAPs diet will be implemented, along with the anti-inflammatory diet, followed by the reintroduction of all fruits and vegetables over a consecutive period of 2 months, for a total of 3 months of intervention. Group 2 will adopt a diet based on general recommendations for healthy eating in accordance with the World Health Organization. The Ethics Committee of the Portuguese Institute of Rheumathology approved this intervention study. The results of this study are expected to determine whether a change in patient nutrition helps to alleviate symptoms, which would optimize medical intervention.

Official Title
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Effects of an Anti-inflammatory Nutritional Intervention in Disease Assessment Parameters, Inflammatory Markers, and Quality of Life of Patients With Fibromyalgia

Conditions
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Fibromyalgia

Intervention / Treatment
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* Behavioral: Anti-inflammatory and low FODMAPs diet
* Behavioral: General healthy eating


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of FM performed by the physician, according to the Rome III criteria of the American College of Rheumatology, revised in 2010; Ability to read and sign the Informed Consent; Stable dose therapy within 4 weeks before study start. Exclusion Criteria: Patients with pathologies that prevent the follow-up of the given dietary protocol; Patients currently undergoing lactation or pregnancy; Prior or current clinical history of abuse of drug or other substances; Change of therapy during the intervention period; Presence of other inflammatory diseases; Uncontrolled medical conditions (eg. Diabetes Mellitus, decompensated heart disease, renal failure, neoplastic diseases, liver diseases).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Anti-inflammatory and low FODMAPs diet<br>The anti-inflammatory diet is characterized by the exclusion of potential inflammatory foods, such as gluten, dairy and processed food, for three months. During the first month, a low FODMAPs diet will be implemented, followed by the reintroduction of all fruits and vegetables over a consecutive period of 2 months. Additionally, some potentially anti-inflammatory foods will be promoted: Omega-3 through specific fish (tuna fish, salmon, sardine, horse mackerel) and nuts, antioxidant rich foods, such as fruit and vegetables, and the maintenance of glycemic index. | Behavioral: Anti-inflammatory and low FODMAPs diet<br>* Exemption of the intake of potentially inflammatory foods, namely gluten, dairy and processed foods, over a consecutive period of 3 months. During the first month, a low FODMAPs diet will be implemented, along with the anti-inflammatory diet, followed by the reintroduction of all fruits and vegetables over a consecutive period of 2 months.<br>|
| Active Comparator: Control<br>Dietary counselling based on general recommendations for healthy eating according to the World Health Organization | Behavioral: General healthy eating<br>* Healthy eating counseling according to the World Health Organization<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in pain, accessed by Visual Analogue Pain Scale | Accessed by Visual Analogue Pain Scale (1 question about pain intensity over the last month, score: 0-10, with 0 = a total pain relief and 10=the greatest pain ever felt). | 1 and 3 months after baseline | 
| Change in pain, accessed by Brief Pain Inventory | Accessed by Brief Pain Inventory (12 questions about pain severity and pain interference; presented with 0-10 scales, with 0=no interference and 10=interferes completely; scale range from 0 to 120 - higher range represent a worst result). | 1 and 3 months after baseline | 
| Change in quality of life accessed by Revised Fibromyalgia Impact Questionnaire | Accessed by Revised Fibromyalgia Impact Questionnaire (20 questions about physical functioning (score 0-3, with 0 = optimal and 3 = worst), and about work difficulty, pain, fatigue, morning tiredness, stiffness, anxiety and depression (score 1-10, with 1 = optimal and 10 = worst; scale range from 0 to 117 - higher range represent a worst result). | 1 and 3 months after baseline | 
| Change in quality of life accessed by Short-form 36 | Accessed by Short-form 36 (36 questions related to the last month, distributed in 8 dimensions: physical function (Score 1-3, with 1 = very limited and 3 = not limited), physical performance, pain, general health, vitality, social function, emotional performance and mental health (score 1-5, with 1 = bad and 5-optimal); scale range from 36 to 142 - higher range represent a worst result). | 1 and 3 months after baseline | 
| Change in inflammatory parameters accessed by serum C-reactive protein measurement | Measurement of serum C-reactive protein (mg/L). | 3 months after baseline | 
| Change in inflammatory parameters accessed by serum erythrocyte sedimentation rate measurement | Measurement of serum erythrocyte sedimentation rate (mm/h). | 3 months after baseline | 
| Change in inflammatory parameters accessed by serum interleukin-8 measurement | Measurement of serum and interleukin-8 (pg/mL). | 3 months after baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in fatigue accessed by Fatigue Severity Survey | Accessed by 1 questionnaire: Fatigue Severity Survey (7 questions with scale from 1 to 7, with 1 = fully disagree and 7 = fully agree; scale range from 7 to 49 - higher range represent a worst result). | 1 and 3 months after baseline | 
| Change in gastrointestinal symptoms accessed by Visual Analog Scale from a list of common gastrointestinal symptoms | Accessed by questionnaire: Visual Analog Scale from a list of common gastrointestinal symptoms (10 questions about gastrointestinal discomfort over the last month, score: 0-10, with 0 = none and 10 = a big discomfort; scale range from 0 to 100 - higher range represent a worst result). | 1 and 3 months after baseline | 
| Change in quality of sleep accessed by Pittsburgh Sleep Quality Index | Accessed by 1 questionnaire: Pittsburgh Sleep Quality Index (18 questions with a scale from 1 to 4, with 1=no sleep disturbance and 4=to much sleep disturbance; scale range from 18 to 72 - higher range represent a worst result). | 1 and 3 months after baseline | 
| Change in weight | Measurement of weight in Kilograms. | 3 months after baseline | 
| Change in waist circumference | Measurement of waist circumference in centimeters. | 3 months after baseline | 
| Change in body fat mass | Measurement by bio-impedance of body fat mass in percentage. | 3 months after baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Antiinflammatory diet, Low FODMAPs diet, Gluten, casein, sugar and processed-foods free diet, Nutrition