Anti-inflammatory Nutritional Intervention in Patients With Fibromyalgia

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

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.

Study Overview

• Status: Completed
• Conditions: Fibromyalgia
• Intervention / Treatment: Behavioral: Anti-inflammatory and low FODMAPs diet; Behavioral: General healthy eating

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 Type: Interventional
• Enrollment (Actual): 46
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Portugal
  • Lisboa, Portugal
    • Instituto Portugues de Reumatologia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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).

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: Anti-inflammatory and low FODMAPs diet; 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.
Active Comparator: Control; Dietary counselling based on general recommendations for healthy eating according to the World Health Organization	Behavioral: General healthy eating; Healthy eating counseling according to the World Health Organization

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Universidade do Porto
• Collaborators: Portuguese Institute of Rheumatology; Centro de Investigação Interdisciplinar Egas Moniz
• Investigators: Principal Investigator: Ana Rita Silva, MD, Universidade do Porto

Publications and helpful links

General Publications

• Uceyler N, Hauser W, Sommer C. Systematic review with meta-analysis: cytokines in fibromyalgia syndrome. BMC Musculoskelet Disord. 2011 Oct 28;12:245. doi: 10.1186/1471-2474-12-245.
• Silva AR, Bernardo A, Costa J, Cardoso A, Santos P, de Mesquita MF, Vaz Patto J, Moreira P, Silva ML, Padrao P. Dietary interventions in fibromyalgia: a systematic review. Ann Med. 2019;51(sup1):2-14. doi: 10.1080/07853890.2018.1564360.
• Statovci D, Aguilera M, MacSharry J, Melgar S. The Impact of Western Diet and Nutrients on the Microbiota and Immune Response at Mucosal Interfaces. Front Immunol. 2017 Jul 28;8:838. doi: 10.3389/fimmu.2017.00838. eCollection 2017.
• Shivappa N, Steck SE, Hurley TG, Hussey JR, Hebert JR. Designing and developing a literature-derived, population-based dietary inflammatory index. Public Health Nutr. 2014 Aug;17(8):1689-96. doi: 10.1017/S1368980013002115. Epub 2013 Aug 14.
• Silva AR, Bernardo A, de Mesquita MF, Vaz-Patto J, Moreira P, Silva ML, Padrao P. An anti-inflammatory and low fermentable oligo, di, and monosaccharides and polyols diet improved patient reported outcomes in fibromyalgia: A randomized controlled trial. Front Nutr. 2022 Aug 15;9:856216. doi: 10.3389/fnut.2022.856216. eCollection 2022.
• Silva AR, Bernardo A, de Mesquita MF, Vaz Patto J, Moreira P, Silva ML, Padrão P. A study protocol for a randomized controlled trial of an anti-inflammatory nutritional intervention in patients with fibromyalgia. Trials. 2021 Mar 9;22(1):198. doi: 10.1186/s13063-021-05146-3.

Study record dates

Study Major Dates

• Study Start (Actual): April 9, 2019
• Primary Completion (Actual): June 4, 2020
• Study Completion (Actual): June 4, 2020

Study Registration Dates

• First Submitted: June 4, 2019
• First Submitted That Met QC Criteria: July 2, 2019
• First Posted (Actual): July 5, 2019

Study Record Updates

• Last Update Posted (Actual): November 15, 2021
• Last Update Submitted That Met QC Criteria: November 12, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: Nutrition; Antiinflammatory diet; Low FODMAPs diet; Gluten, casein, sugar and processed-foods free diet
• Additional Relevant MeSH Terms: Nervous System Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Neuromuscular Diseases; Fibromyalgia; Myofascial Pain Syndromes; Anti-Inflammatory Agents
• Other Study ID Numbers: AIDFM2019

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No