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出境医 / 临床实验 / Anti-inflammatory Nutritional Intervention in Patients With Fibromyalgia

Anti-inflammatory Nutritional Intervention in Patients With Fibromyalgia

Study Description
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.

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 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
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : December 2020
Arms and Interventions
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
Outcome Measures
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.


Eligibility Criteria
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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).
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Ana Rita Silva, MD 963288631 ext +351 csilva.anarita@gmail.com

Locations
Layout table for location information
Portugal
Instituto Português de Reumatologia Recruiting
Lisboa, Portugal
Principal Investigator: Ana Rita Silva, MD         
Sub-Investigator: Patrícia Padrão, PhD         
Sub-Investigator: Maria Leonor Silva, PhD         
Sub-Investigator: José Vaz Patto, Dr         
Sub-Investigator: Fernanda Mesquita, PhD         
Sub-Investigator: Alexandra Bernardo, PhD         
Sub-Investigator: Pedro Moreira, PhD         
Sponsors and Collaborators
Universidade do Porto
Portuguese Institute of Rheumatology
Centro de Investigação Interdisciplinar Egas Moniz
Investigators
Layout table for investigator information
Principal Investigator: Ana Rita Silva, MD Universidade do Porto
Tracking Information
First Submitted Date  ICMJE June 4, 2019
First Posted Date  ICMJE July 5, 2019
Last Update Posted Date June 16, 2020
Actual Study Start Date  ICMJE April 9, 2019
Estimated Primary Completion Date October 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 2, 2019)
  • 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 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).
  • Change in inflammatory parameters accessed by serum interleukin-8 measurement [ Time Frame: 3 months after baseline ]
    Measurement of serum and interleukin-8 (pg/mL).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 2, 2019)
  • 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).
  • 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).
  • 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).
  • Change in weight [ Time Frame: 3 months after baseline ]
    Measurement of weight in Kilograms.
  • Change in waist circumference [ Time Frame: 3 months after baseline ]
    Measurement of waist circumference in centimeters.
  • Change in body fat mass [ Time Frame: 3 months after baseline ]
    Measurement by bio-impedance of body fat mass in percentage.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Anti-inflammatory Nutritional Intervention in Patients With Fibromyalgia
Official Title  ICMJE Effects of an Anti-inflammatory Nutritional Intervention in Disease Assessment Parameters, Inflammatory Markers, and Quality of Life of Patients With Fibromyalgia
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Fibromyalgia
Intervention  ICMJE
  • 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.
  • Behavioral: General healthy eating
    Healthy eating counseling according to the World Health Organization
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: Anti-inflammatory and low FODMAPs diet
  • Active Comparator: Control
    Dietary counselling based on general recommendations for healthy eating according to the World Health Organization
    Intervention: Behavioral: General healthy eating
Publications *
  • Uçeyler N, Häuser 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. Review.
  • Silva AR, Bernardo A, Costa J, Cardoso A, Santos P, de Mesquita MF, Vaz Patto J, Moreira P, Silva ML, Padrão 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. Review.
  • Shivappa N, Steck SE, Hurley TG, Hussey JR, Hébert 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, 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 2, 2019) 		100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date October 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Ana Rita Silva, MD 963288631 ext +351 csilva.anarita@gmail.com
Listed Location Countries  ICMJE Portugal
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04007705
Other Study ID Numbers  ICMJE AIDFM2019
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Universidade do Porto
Study Sponsor  ICMJE Universidade do Porto
Collaborators  ICMJE
  • Portuguese Institute of Rheumatology
  • Centro de Investigação Interdisciplinar Egas Moniz
Investigators  ICMJE
Principal Investigator: Ana Rita Silva, MD Universidade do Porto
PRS Account Universidade do Porto
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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