FibromyalgiaNCT04007705
Anti-inflammatory Nutritional Intervention in Patients With Fibromyalgia
A study testing Anti-inflammatory and low FODMAPs diet and General healthy eating in people with Fibromyalgia, run by Universidade do Porto at 1 site in Portugal.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Anti-inflammatory and low FODMAPs diet and General healthy eating
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 sitePortugal
- Study dates
- 9 Apr 2019to 4 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Fibromyalgia
- Being tested
- Anti-inflammatory and low FODMAPs diet, General healthy eating
- Keywords
- Antiinflammatory diet, Low FODMAPs diet, Gluten, casein, sugar and processed-foods free diet, Nutrition
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti-inflammatory and low FODMAPs dietBehavioural
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.
General healthy eatingBehavioural
Healthy eating counseling according to the World Health Organization
| Study group | Role | What they receive |
|---|---|---|
| Anti-inflammatory and low FODMAPs diet | Experimental | 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. Receives: Behavioral: Anti-inflammatory and low FODMAPs diet |
| Control | Active comparator | Dietary counselling based on general recommendations for healthy eating according to the World Health Organization Receives: Behavioral: General healthy eating |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 3 months after baseline
Change in inflammatory parameters accessed by serum erythrocyte sedimentation rate measurement
Measurement of serum erythrocyte sedimentation rate (mm/h).
Measured: 3 months after baseline
Change in inflammatory parameters accessed by serum interleukin-8 measurement
Measurement of serum and interleukin-8 (pg/mL).
Measured: 3 months after baseline
Secondary outcomes (6)
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).
Measured: 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).
Measured: 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).
Measured: 1 and 3 months after baseline
Change in weight
Measurement of weight in Kilograms.
Measured: 3 months after baseline
Change in waist circumference
Measurement of waist circumference in centimeters.
Measured: 3 months after baseline
Change in body fat mass
Measurement by bio-impedance of body fat mass in percentage.
Measured: 3 months after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2019
- Study start9 Apr 2019
- Primary completion4 Jun 2020
- Study completion4 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade do Porto
- Sponsor type
- University, hospital or other
- Collaborators
- Portuguese Institute of Rheumatology, Centro de Investigação Interdisciplinar Egas Moniz
- Responsible party
- Sponsor
- Investigators
- Ana Rita Silva, MD, Principal investigator, Universidade do Porto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04007705
- Sponsor's protocol ID
- AIDFM2019
- Status last verified
- Nov 2021
- First submitted
- 4 Jun 2019
- Last updated
- 15 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 22034969Silva 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.
PubMed 30735059Statovci 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.
PubMed 28804483Shivappa 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.
PubMed 23941862Silva 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.
PubMed 36091254Silva AR, Bernardo A, de Mesquita MF, Vaz Patto J, Moreira P, Silva ML, Padrao 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.
PubMed 33743794
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of an Anti-inflammatory Nutritional Intervention in Disease Assessment Parameters, Inflammatory Markers, and Quality of Life of Patients With Fibromyalgia
- ClinicalTrials.gov ID
- NCT04007705
- Acronym / sponsor ID
- AIDFM2019
- Conditions
- Fibromyalgia
- Keywords
- Antiinflammatory diet, Low FODMAPs diet, Gluten, casein, sugar and processed-foods free diet, Nutrition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Universidade do PortoUniversity, hospital or other
- Collaborators
- Portuguese Institute of Rheumatology, Centro de Investigação Interdisciplinar Egas Moniz
- Study start
- 9 Apr 2019 (actual)
- Primary completion
- 4 Jun 2020 (actual)
- Study completion
- 4 Jun 2020 (actual)
- First posted
- 5 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anti-inflammatory and low FODMAPs diet | Experimental | Behavioral: Anti-inflammatory and low FODMAPs dietThe 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. |
| Control | Active comparator | Behavioral: General healthy eatingDietary counselling based on general recommendations for healthy eating according to the World Health Organization |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anti-inflammatory and low FODMAPs dietExemption 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. | Behavioural | Anti-inflammatory and low FODMAPs diet |
| General healthy eatingHealthy eating counseling according to the World Health Organization | Behavioural | Control |
Primary outcome
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).
6 secondary outcomes
Change in fatigue accessed by Fatigue Severity Survey
Time frame: 1 and 3 months after baseline
Change in gastrointestinal symptoms accessed by Visual Analog Scale from a list of common gastrointestinal symptoms
Time frame: 1 and 3 months after baseline
Change in quality of sleep accessed by Pittsburgh Sleep Quality Index
Time frame: 1 and 3 months after baseline
Change in weight
Time frame: 3 months after baseline
Change in waist circumference
Time frame: 3 months after baseline
Change in body fat mass
Time frame: 3 months after baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2021.
- Results publication: PubMed 22034969Uceyler 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.
- Results publication: PubMed 30735059Silva 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.
- Results publication: PubMed 28804483Statovci 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.
- Results publication: PubMed 23941862Shivappa 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.
- Derived from this study: PubMed 36091254Silva 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.
- Derived from this study: PubMed 33743794Silva AR, Bernardo A, de Mesquita MF, Vaz Patto J, Moreira P, Silva ML, Padrao 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ana Rita Silva, MD principal investigator
Universidade do Porto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anti-inflammatory and low FODMAPs diet and General healthy eating in people with Fibromyalgia, run by Universidade do Porto at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pain, accessed by Visual Analogue Pain Scale (time frame: 1 and 3 months after baseline). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04007705, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2021.