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Anti-inflammatory Nutritional Intervention in Patients With Fibromyalgia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04007705
Recruitment Status : Completed
First Posted : July 5, 2019
Last Update Posted : November 15, 2021
Sponsor:
Collaborators:
Portuguese Institute of Rheumatology
Centro de Investigação Interdisciplinar Egas Moniz
Information provided by (Responsible Party):
Universidade do Porto

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.

Condition or disease Intervention/treatment Phase
Fibromyalgia Behavioral: Anti-inflammatory and low FODMAPs diet Behavioral: General healthy eating Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Effects of an Anti-inflammatory Nutritional Intervention in Disease Assessment Parameters, Inflammatory Markers, and Quality of Life of Patients With Fibromyalgia
Actual Study Start Date : April 9, 2019
Actual Primary Completion Date : June 4, 2020
Actual Study Completion Date : June 4, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fibromyalgia

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




Primary Outcome Measures :
  1. 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).

  2. 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).

  3. 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).

  4. 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).

  5. 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).

  6. 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).

  7. Change in inflammatory parameters accessed by serum interleukin-8 measurement [ Time Frame: 3 months after baseline ]
    Measurement of serum and interleukin-8 (pg/mL).


Secondary Outcome Measures :
  1. Change in fatigue accessed by Fatigue Severity Survey [ Time Frame: 1 and 3 months after baseline ]
    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).

  2. Change in gastrointestinal symptoms accessed by Visual Analog Scale from a list of common gastrointestinal symptoms [ Time Frame: 1 and 3 months after baseline ]
    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).

  3. Change in quality of sleep accessed by Pittsburgh Sleep Quality Index [ Time Frame: 1 and 3 months after baseline ]
    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).

  4. Change in weight [ Time Frame: 3 months after baseline ]
    Measurement of weight in Kilograms.

  5. Change in waist circumference [ Time Frame: 3 months after baseline ]
    Measurement of waist circumference in centimeters.

  6. Change in body fat mass [ Time Frame: 3 months after baseline ]
    Measurement by bio-impedance of body fat mass in percentage.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04007705


Locations
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Portugal
Instituto Português de Reumatologia
Lisboa, Portugal
Sponsors and Collaborators
Universidade do Porto
Portuguese Institute of Rheumatology
Centro de Investigação Interdisciplinar Egas Moniz
Investigators
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Principal Investigator: Ana Rita Silva, MD Universidade do Porto
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Universidade do Porto
ClinicalTrials.gov Identifier: NCT04007705    
Other Study ID Numbers: AIDFM2019
First Posted: July 5, 2019    Key Record Dates
Last Update Posted: November 15, 2021
Last Verified: November 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Universidade do Porto:
Antiinflammatory diet
Low FODMAPs diet
Gluten, casein, sugar and processed-foods free diet
Nutrition
Additional relevant MeSH terms:
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Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Anti-Inflammatory Agents