FibromyalgiaNCT03129906
Impact of the Restriction of Sources of Gluten in Fibromyalgia Patients
A study testing Gluten and Rice protein in people with Fibromyalgia, run by Federal University of Minas Gerais at 1 site in Brazil.
Trial summary
The aim of this study is to evaluate the impact of gluten-free diets on symptoms and inflammatory markers in individuals with previous diagnosis of fibromyalgia (FM), as well as to identify the presence of non-celiac gluten sensitivity (NCSG) in individuals with FM. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Gluten and Rice protein
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteBrazil
- Study dates
- 25 Sep 2015to 4 Oct 2016
- 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 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women between 18 and 65 years of age with prior clinical diagnosis of FM, according to the American College of Rheumatology criteria of 2010
Who cannot join
- Subjects diagnosed with positive serology for celiac disease or allergy to wheat
- Subjects diagnosed with autoimmune diseases
- Subjects with diseases that are not part of the comorbidities associated with FM and t hat could influence the results of the study
- Pregnant or lactating women
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Laboratório de Aterosclerose e Bioquimica Nutricional
Belo Horizonte, Minas Gerais, 30161-970
About this study
The aim of this study is to evaluate the impact of gluten-free diets on symptoms and inflammatory markers in individuals with previous diagnosis of fibromyalgia (FM), as well as to identify the presence of non-celiac gluten sensitivity (NCSG) in individuals with FM. Patients with FM diagnosis will be kept on a gluten-free diet for a 10 weeks. In the 7th week, they will receive placebo capsules for 7 days and after washout, capsules containing gluten for another 7 days. A questionnaire based on Salerno protocol will be applied to evaluate the presence of NCGS in the beginning, 8th week and 10 week.
Read the detailed description
Fibromyalgia (FM) is a chronic and widespread pain condition, usually accompanied by several associated symptoms such as fatigue, sleep disorder, headache, irritable bowel syndrome and mood disorders. Recent studies point to the possibility of gluten protein having a role in the development of FM symptoms in a subgroup of patients. Fourteen patients with FM diagnosis will be kept on a diet restrict in gluten-free foods for a period 10 weeks. At the 7th week they received rice protein isolate capsules (placebo) for 7 days, followed by a 3-day wash-out and a new challenge with capsules containing 8 g/day of gluten (corresponding to 6,3g gluten protein) for another 7 days. In the initial period, at 8th week (final of placebo period) and after challenge with gluten (10th week), blood will be collected for analysis of inflammatory markers. Questionnaires will be carried out to evaluate the quantity and severity of FM symptoms and the impact of FM on daily routine. Inflammatory markers (IL-1bera, IL-6 and IL-10) will be evaluated in the blood. In the challenger period (gluten or placebo) questionnaires will be carried out to evaluate the quantity and severity of symptoms related to fibromyalgia and the impact of fibromyalgia on a daily basis. In addition, a questionnaire based on Salerno protocol was applied to evaluate the presence of NCGS.
- Conditions
- Fibromyalgia
- Being tested
- Gluten, Rice protein
- Keywords
- Fibromyalgia; non-celiac gluten sensitivity
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GlutenDietary supplement
Rice proteinDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Gluten | Active comparator | Capsules containing 8 g/day of gluten (6,3g of protein) were blindly administered for 7 days Receives: Dietary Supplement: Gluten |
| Rice protein | Placebo comparator | Capsules containing 6,4 g/day of rice protein were blindly administered for 7 days Receives: Dietary Supplement: Rice protein |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in fibromyalgia Symptoms by Salerno protocol
Self report of symptoms intensity in the last week. Each item is scored 0 (no symptom) to 10 (very intense symptom).
Measured: Baseline, 4th and 8th weeks, 10th week
Secondary outcomes (7)
Changes in body weight
measured in weight in kg
Measured: Baseline, 8th and 10th weeks
Height
measured in meters
Measured: baseline
changes in BMI
in kg of body weight/square of height
Measured: Baseline, 8th and 10th weeks
Changes in IL-6 blood concentration
measure by ELISA in ug/mL
Measured: Baseline, 8th and 10th weeks
Changes in IL-10 blood concentration
measure by ELISA in ug/mL
Measured: Baseline, 8th and 10th weeks
Changes in IL-1beta blood concentration
measure by ELISA in ug/mL
Measured: Baseline, 8th and 10th weeks
changes in Food intake
measured in % of kcal
Measured: Baseline, 8th and 10th weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2017
- Study start25 Sep 2015
- Primary completion4 Oct 2016
- Study completion4 Oct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- All participants received placebo capsules and, after that, gluten capsules.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Minas Gerais
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jacqueline Isaura Alvarez Leite, Federal University of Minas Gerais
- Investigators
- Jacqueline I Alvarez-Leite, MD, PhD, Principal investigator, Federal University of Minas Gerais
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03129906
- Sponsor's protocol ID
- 48529415.8.0000.5149
- Status last verified
- Apr 2017
- First submitted
- 19 Apr 2017
- Last updated
- 26 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of the Restriction of Sources of Gluten in Fibromyalgia Patients
- ClinicalTrials.gov ID
- NCT03129906
- Acronym / sponsor ID
- 48529415.8.0000.5149
- Conditions
- Fibromyalgia
- Keywords
- Fibromyalgia; non-celiac gluten sensitivity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Federal University of Minas GeraisUniversity, hospital or other
- Study start
- 25 Sep 2015
- Primary completion
- 4 Oct 2016 (actual)
- Study completion
- 4 Oct 2016 (actual)
- First posted
- 26 Apr 2017 (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.
The aim of this study is to evaluate the impact of gluten-free diets on symptoms and inflammatory markers in individuals with previous diagnosis of fibromyalgia (FM), as well as to identify the presence of non-celiac gluten sensitivity (NCSG) in individuals with FM. Patients with FM diagnosis will be kept on a gluten-free diet for a 10 weeks. In the 7th week, they will receive placebo capsules for 7 days and after washout, capsules containing gluten for another 7 days. A questionnaire based on Salerno protocol will be applied to evaluate the presence of NCGS in the beginning, 8th week and 10 week.
Detailed description
Fibromyalgia (FM) is a chronic and widespread pain condition, usually accompanied by several associated symptoms such as fatigue, sleep disorder, headache, irritable bowel syndrome and mood disorders. Recent studies point to the possibility of gluten protein having a role in the development of FM symptoms in a subgroup of patients. Fourteen patients with FM diagnosis will be kept on a diet restrict in gluten-free foods for a period 10 weeks. At the 7th week they received rice protein isolate capsules (placebo) for 7 days, followed by a 3-day wash-out and a new challenge with capsules containing 8 g/day of gluten (corresponding to 6,3g gluten protein) for another 7 days. In the initial period, at 8th week (final of placebo period) and after challenge with gluten (10th week), blood will be collected for analysis of inflammatory markers. Questionnaires will be carried out to evaluate the quantity and severity of FM symptoms and the impact of FM on daily routine. Inflammatory markers (IL-1bera, IL-6 and IL-10) will be evaluated in the blood. In the challenger period (gluten or placebo) questionnaires will be carried out to evaluate the quantity and severity of symptoms related to fibromyalgia and the impact of fibromyalgia on a daily basis. In addition, a questionnaire based on Salerno protocol was applied to evaluate the presence of NCGS.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- All participants received placebo capsules and, after that, gluten capsules.
| Arm | Type | Receives |
|---|---|---|
| Gluten | Active comparator | Dietary Supplement: GlutenCapsules containing 8 g/day of gluten (6,3g of protein) were blindly administered for 7 days |
| Rice protein | Placebo comparator | Dietary Supplement: Rice proteinCapsules containing 6,4 g/day of rice protein were blindly administered for 7 days |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Women between 18 and 65 years of age with prior clinical diagnosis of FM, according to the American College of Rheumatology criteria of 2010
Key exclusion criteria (4 listed)
- Subjects diagnosed with positive serology for celiac disease or allergy to wheat
- Subjects diagnosed with autoimmune diseases
- Subjects with diseases that are not part of the comorbidities associated with FM and t hat could influence the results of the study
- Pregnant or lactating women
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 |
|---|---|---|
| Gluten | Dietary supplement | Gluten |
| Rice protein | Dietary supplement | Rice protein |
Primary outcome
Changes in fibromyalgia Symptoms by Salerno protocol
Time frame: Baseline, 4th and 8th weeks, 10th week
Self report of symptoms intensity in the last week. Each item is scored 0 (no symptom) to 10 (very intense symptom).
7 secondary outcomes
Changes in body weight
Time frame: Baseline, 8th and 10th weeks
Height
Time frame: baseline
changes in BMI
Time frame: Baseline, 8th and 10th weeks
Changes in IL-6 blood concentration
Time frame: Baseline, 8th and 10th weeks
Changes in IL-10 blood concentration
Time frame: Baseline, 8th and 10th weeks
Changes in IL-1beta blood concentration
Time frame: Baseline, 8th and 10th weeks
changes in Food intake
Time frame: Baseline, 8th and 10th weeks
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 26 Apr 2017.
- Individual participant dataSharing planned: No
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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.
Jacqueline I Alvarez-Leite, MD, PhD principal investigator
Federal University of Minas Gerais
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gluten and Rice protein in people with Fibromyalgia, run by Federal University of Minas Gerais at 1 site in Brazil.
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 1 inclusion and 4 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 26 Apr 2017. 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 Brazil. 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. Some participants in this study may receive a placebo. 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?
Changes in fibromyalgia Symptoms by Salerno protocol (time frame: Baseline, 4th and 8th weeks, 10th week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Apr 2017.