FibromyalgiaNCT01881360
Efficacy of a Gluten-free Diet for the Treatment of Fibromyalgia
A study testing Gluten-free diet and Hypocaloric diet in people with Fibromyalgia, run by Universidad de Granada at 1 site in Spain.
Trial summary
Fibromyalgia patients frequently suffer from symptoms similar to those of adult celiac disease, raising the possibility that some fibromyalgia patients experience oligosymptomatic celiac disease or non-celiac gluten intolerance. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Gluten-free diet and Hypocaloric diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2013to Oct 2014
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients diagnosed with fibromyalgia according to the 1990 American College of Rheumatology diagnostic criteria.
- Patients who successfully complete the screening process for sufficient celiac-type symptoms
- Negative transglutaminase antibodies serological testing.
- Signed informed consent to participate
Who cannot join
- Patients suffering from any disease that could prevent them from following any of the suggested diet protocols
- Current or previous history of substance abuse
- Pregnancy and lactation
Trial locations and contacts
1 site in 1 country.
Spain1 site
Instituto de Neurociencias "Federico Oloriz"
Granada, Granada, 18012
About this study
Official title: Comparison Between a Gluten-free Diet and a Hypocaloric Diet for the Treatment of Patients With Fibromyalgia and Celiac-type Symptoms
Fibromyalgia patients frequently suffer from symptoms similar to those of adult celiac disease, raising the possibility that some fibromyalgia patients experience oligosymptomatic celiac disease or non-celiac gluten intolerance. The objective of this study is to compare the effect of a gluten-free diet with a hypocaloric diet in patients with fibromyalgia and celiac-type symptoms.
Read the detailed description
Fibromyalgia, a chronic pain disorder, is characterized by generalized chronic musculoskeletal pain that is usually accompanied by several other clinical manifestations that contribute to a diminished quality of life, such as sleep disturbances, chronic fatigue, mood disorders, and cognitive difficulties. Many patients with fibromyalgia suffer from gastrointestinal and extra-intestinal symptoms that are similar to those experienced by adult celiac disease patients such as abdominal pain, dyspepsia, nausea, diarrhea, constipation, fatigue, pain and mood changes. This raises the possibility that some patients with fibromyalgia may also suffer from oligosymptomatic celiac disease or non-celiac gluten intolerance. On the other hand, the emerging evidence linking obesity with fibromyalgia and the high prevalence of overweight among fibromyalgia patients suggest a potential benefit for weight loss among these patients. Thus, the main objective of this study is to compare the efficacy of a gluten-free diet (GFD) with a hypocaloric diet (HCD) in patients with fibromyalgia that also experience celiac-type symptoms.
- Conditions
- Fibromyalgia
- Being tested
- Gluten-free diet, Hypocaloric diet
- Keywords
- fibromyalgia, celiac-type symptoms, gluten-free diet, hypocaloric diet
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gluten-free dietOther
A diet that is free of the gluten component
Hypocaloric dietOther
A standard hypocaloric diet with a daily 1500 caloric intake.
| Study group | Role | What they receive |
|---|---|---|
| Gluten-free diet | Experimental | Not described Receives: Other: Gluten-free diet |
| Hypocaloric diet | Active comparator | Not described Receives: Other: Hypocaloric diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change, between baseline and endpoint, in the number of experienced celiac-type symptoms
Measured: 0, 4, 8, 12, 18 and 24 weeks
Secondary outcomes (7)
Change, between baseline and endpoint, in the Body Mass Index
Measured: 0, 4, 8, 12, 18 and 24 weeks
Change, between baseline and endpoint, in the Revised Fibromyalgia Impact Questionnaire total score
Measured: 0, 4, 8, 12, 18 and 24 weeks
Change, between baseline and endpoint, in the Pittsburgh Sleep Quality Index
Measured: 0, 4, 8, 12, 18 and 24 weeks
Change, between baseline and endpoint, in the Brief Pain Inventory
Measured: 0, 4, 8, 12, 18 and 24 weeks
Change, between baseline and endpoint, in the Beck Depression Inventory
Measured: 0, 4, 8, 12, 18 and 24 weeks
Change, between baseline and endpoint, in the Short-form Health Survey
Measured: 0, 4, 8, 12, 18 and 24 weeks
Change, between baseline and endpoint, in the State-Trait Anxiety Inventory
Measured: 0, 4, 8, 12, 18, 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2013 (estimated)
- Study startJan 2013
- Primary completionOct 2014
- Study completionOct 2014
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Granada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elena Pita Calandre, Universidad de Granada
- Investigators
- Elena P. Calandre, M.D., Principal investigator, Universidad de Granada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01881360
- Sponsor's protocol ID
- FMS-GFD-013
- Status last verified
- Dec 2014
- First submitted
- 17 Jun 2013
- Last updated
- 3 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between a Gluten-free Diet and a Hypocaloric Diet for the Treatment of Patients With Fibromyalgia and Celiac-type Symptoms
- ClinicalTrials.gov ID
- NCT01881360
- Acronym / sponsor ID
- FMS-GFD-013
- Conditions
- Fibromyalgia
- Keywords
- fibromyalgia, celiac-type symptoms, gluten-free diet, hypocaloric diet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Universidad de GranadaUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 19 Jun 2013 (estimated)
- 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.
Fibromyalgia patients frequently suffer from symptoms similar to those of adult celiac disease, raising the possibility that some fibromyalgia patients experience oligosymptomatic celiac disease or non-celiac gluten intolerance. The objective of this study is to compare the effect of a gluten-free diet with a hypocaloric diet in patients with fibromyalgia and celiac-type symptoms.
Detailed description
Fibromyalgia, a chronic pain disorder, is characterized by generalized chronic musculoskeletal pain that is usually accompanied by several other clinical manifestations that contribute to a diminished quality of life, such as sleep disturbances, chronic fatigue, mood disorders, and cognitive difficulties. Many patients with fibromyalgia suffer from gastrointestinal and extra-intestinal symptoms that are similar to those experienced by adult celiac disease patients such as abdominal pain, dyspepsia, nausea, diarrhea, constipation, fatigue, pain and mood changes. This raises the possibility that some patients with fibromyalgia may also suffer from oligosymptomatic celiac disease or non-celiac gluten intolerance. On the other hand, the emerging evidence linking obesity with fibromyalgia and the high prevalence of overweight among fibromyalgia patients suggest a potential benefit for weight loss among these patients. Thus, the main objective of this study is to compare the efficacy of a gluten-free diet (GFD) with a hypocaloric diet (HCD) in patients with fibromyalgia that also experience celiac-type symptoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gluten-free diet | Experimental | Other: Gluten-free diet |
| Hypocaloric diet | Active comparator | Other: Hypocaloric diet |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult patients diagnosed with fibromyalgia according to the 1990 American College of Rheumatology diagnostic criteria.
- Patients who successfully complete the screening process for sufficient celiac-type symptoms
- Negative transglutaminase antibodies serological testing.
- Signed informed consent to participate
Key exclusion criteria (3 listed)
- Patients suffering from any disease that could prevent them from following any of the suggested diet protocols
- Current or previous history of substance abuse
- Pregnancy and lactation
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-free dietA diet that is free of the gluten component | Other | Gluten-free diet |
| Hypocaloric dietA standard hypocaloric diet with a daily 1500 caloric intake. | Other | Hypocaloric diet |
Primary outcome
Change, between baseline and endpoint, in the number of experienced celiac-type symptoms
Time frame: 0, 4, 8, 12, 18 and 24 weeks
7 secondary outcomes
Change, between baseline and endpoint, in the Body Mass Index
Time frame: 0, 4, 8, 12, 18 and 24 weeks
Change, between baseline and endpoint, in the Revised Fibromyalgia Impact Questionnaire total score
Time frame: 0, 4, 8, 12, 18 and 24 weeks
Change, between baseline and endpoint, in the Pittsburgh Sleep Quality Index
Time frame: 0, 4, 8, 12, 18 and 24 weeks
Change, between baseline and endpoint, in the Brief Pain Inventory
Time frame: 0, 4, 8, 12, 18 and 24 weeks
Change, between baseline and endpoint, in the Beck Depression Inventory
Time frame: 0, 4, 8, 12, 18 and 24 weeks
Change, between baseline and endpoint, in the Short-form Health Survey
Time frame: 0, 4, 8, 12, 18 and 24 weeks
Change, between baseline and endpoint, in the State-Trait Anxiety Inventory
Time frame: 0, 4, 8, 12, 18, 24 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 3 Dec 2014.
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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.
Elena P. Calandre, M.D. principal investigator
Universidad de Granada
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-free diet and Hypocaloric diet in people with Fibromyalgia, run by Universidad de Granada at 1 site in Spain.
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 4 inclusion and 3 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 3 Dec 2014. 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 Spain. 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, between baseline and endpoint, in the number of experienced celiac-type symptoms (time frame: 0, 4, 8, 12, 18 and 24 weeks). 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 3 Dec 2014.