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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
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.
Healthy eating counseling according to the World Health Organization
Instituto Português de Reumatologia
Lisbon, Portugal
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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 3 months after baseline
Change in inflammatory parameters accessed by serum erythrocyte sedimentation rate measurement
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Measurement of serum erythrocyte sedimentation rate (mm/h).
Time frame: 3 months after baseline
Change in inflammatory parameters accessed by serum interleukin-8 measurement
Measurement of serum and interleukin-8 (pg/mL).
Time frame: 3 months after baseline
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).
Time frame: 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).
Time frame: 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).
Time frame: 1 and 3 months after baseline
Change in weight
Measurement of weight in Kilograms.
Time frame: 3 months after baseline
Change in waist circumference
Measurement of waist circumference in centimeters.
Time frame: 3 months after baseline
Change in body fat mass
Measurement by bio-impedance of body fat mass in percentage.
Time frame: 3 months after baseline