Effects of an Anti-inflammatory Nutritional Intervention in Disease Assessment Parameters, Inflammatory Markers, and Quality of Life of Patients With Fibromyalgia
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Universidade do Porto
- Enrollment
- 46
- Locations
- 1
- Primary Endpoint
- Change in pain, accessed by Visual Analogue Pain Scale
Study Overview
Brief Summary
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
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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).
Arms & Interventions
Anti-inflammatory and low FODMAPs diet
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.
Intervention: Anti-inflammatory and low FODMAPs diet (Behavioral)
Control
Dietary counselling based on general recommendations for healthy eating according to the World Health Organization
Intervention: General healthy eating (Behavioral)
Outcomes
Primary Outcomes
Change in pain, accessed by Visual Analogue Pain Scale
Time Frame: 1 and 3 months after baseline
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).
Change in pain, accessed by Brief Pain Inventory
Time Frame: 1 and 3 months after baseline
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).
Change in quality of life accessed by Revised Fibromyalgia Impact Questionnaire
Time Frame: 1 and 3 months after baseline
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).
Change in inflammatory parameters accessed by serum interleukin-8 measurement
Time Frame: 3 months after baseline
Measurement of serum and interleukin-8 (pg/mL).
Change in quality of life accessed by Short-form 36
Time Frame: 1 and 3 months after baseline
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).
Change in inflammatory parameters accessed by serum C-reactive protein measurement
Time Frame: 3 months after baseline
Measurement of serum C-reactive protein (mg/L).
Change in inflammatory parameters accessed by serum erythrocyte sedimentation rate measurement
Time Frame: 3 months after baseline
Measurement of serum erythrocyte sedimentation rate (mm/h).
Secondary Outcomes
- Change in waist circumference(3 months after baseline)
- Change in fatigue accessed by Fatigue Severity Survey(1 and 3 months after baseline)
- Change in gastrointestinal symptoms accessed by Visual Analog Scale from a list of common gastrointestinal symptoms(1 and 3 months after baseline)
- Change in weight(3 months after baseline)
- Change in body fat mass(3 months after baseline)
- Change in quality of sleep accessed by Pittsburgh Sleep Quality Index(1 and 3 months after baseline)