SpondyloarthritisNCT04386538
Effect of a Low Starch Diet in Patients With Ankylosing Spondylitis
A study testing Low Starch Diet (LSD) and General healthy eating in people with Spondyloarthritis and Ankylosing Spondylitis, run by Universidade do Porto at 1 site in Portugal.
Trial summary
The aim of this study is to explore the effect of a low starch diet (reduction of at least 40%) in the gut bacteria modulation, especially Klebsiella pneumoniae, and its relation to disease activity, functional impairment and quality of life in patients with Ankylosing Spondylitis (AS). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Spondyloarthritis, Ankylosing Spondylitis
- What is being tested?
- Low Starch Diet (LSD) 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
- 150 participants
- Where
- 1 sitePortugal
- Study dates
- 3 Jan 2022to 30 Dec 2022
- 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
- Age between 18 and 75 years old
- Available to comply with study protocol
- Ability to read and sign the Informed Consent
- Diagnosis of Ankylosing Spondylitis performed by the rheumatologist, according to the ASAS classification criteria, revised in 2016
- Positive HLA-B27allele
- Stable dose therapy within 3 months before selection
Who cannot join
- Pregnant, breastfeeding or planning to become pregnant within the study period
- Prior or current clinical history of drug or other substances abuse
- Subjects with uncontrolled clinical conditions, like neoplastic diseases, renal failure, liver impairment, uncompensated cardiac disease
- Dietetic restrictions due to religious believes or others incompatible with the study protocol
- Impossibility to attend to the mandatory personal clinical evaluation
- Presence of pacemaker, making impossible to perform the impedance body composition analysis
- Change in therapy during the intervention period
Trial locations and contacts
1 site in 1 country.
Portugal1 site, 1 recruiting
- Recruiting
Instituto Português de Reumatologia
Lisbon
Alexandra Cardoso, MD, +351926142356, alexandra.cardoso@gmail.com
Alexandra Cardoso, MD
About this study
Official title: Effect of a Low Starch Diet in the Gut Microbiome Modulation, Disease Activity and Quality of Life in Patients With Ankylosing Spondylitis
The aim of this study is to explore the effect of a low starch diet (reduction of at least 40%) in the gut bacteria modulation, especially Klebsiella pneumoniae, and its relation to disease activity, functional impairment and quality of life in patients with Ankylosing Spondylitis (AS).
Read the detailed description
Ankylosing spondylitis (AS) is a chronic inflammatory rheumatic disease characterized by axial inflammation and with unknown aetiology. The immune system dysregulation is known, where genetic factors play a key role, in particular, the susceptibility associated to the HLA-B27 allele. The presence of this genetic marker, seems to trigger an abnormal response of the individual, under the action of determine microorganisms, and probably, the combination of these two factors may contribute to the manifestation of the disease, through the induction of an immune and cytolytic response, leading to tissue injury and promoting the inflammation. Intestinal microbiota involvement in spondylarthritis is a controversial issue, however, was observed an increased concentration of Klebsiella pneumoniae bacteria in the faeces of AS patients. It has been suggested that an intervention aiming these bacteria's starving could benefit the reduction of the inflammatory processes and be a part of AS treatment. The bowel microflora depends on dietary intake, like undigested starch, for their growth. Some studies have highlighted the relation between the intake of starch and the disease activity. The modulation of the microbiota, particularly, the reduction of Klebsiella, may be beneficial as a complementary approach to AS therapy.
A sample of 300 patients with AS, followed-up at Portuguese Institute of Rheumatology in Lisbon, will be randomly assigned in two groups. The group A will adopt a balanced diet based on the general recommendations for healthy eating by the World Health Organization, for a period of 6 weeks. In Group B will be implemented an individual balanced low starch diet, which is characterized by the significant reduction of starchy food, of at least 40% of the total daily ingested starch.
The change in biometric data, body composition, intestinal Klebsiella will be related to food intake, disease activity and quality of life assessments. These data will be compared between the 2 groups (diet A versus diet B), obtaining measures on the effect of each diet on the analyzed variables.
- Conditions
- Spondyloarthritis, Ankylosing Spondylitis
- Being tested
- Low Starch Diet (LSD), General healthy eating
- Keywords
- Low Starch Diet (LSD), Klebsiella, Ankylosing Spondylitis, Disease activity, Quality of life, Nutrition, Diet therapy, Spondyloarthritis, Rheumatic Diseases, Spondylitis
- Medical subject headings
- Spondylarthritis, Spondylitis, Ankylosing, Klebsiella Infections, Rheumatic Diseases, Spondylitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low Starch Diet (LSD)Behavioural
6-week balanced diet program, adapted to individual energetic needs, with significant reduction of high content starchy food, naturally present in plant cells, roots, tubers, seeds, beans, legumes, fruits, and highly present in most farinaceous grains, especially in potatoes, corn, rice, pasta, bread, cookies and cakes.
General healthy eatingBehavioural
6-week balanced healthy eating counseling program, according to the World Health Organization recommendations.
| Study group | Role | What they receive |
|---|---|---|
| Low Starch Diet (LSD) | Experimental | Participants will receive the low starch diet program: restricts the daily amount of ingested rich starch food, to a reduction of at least 40% compared to usual daily individual starch intake. Receives: Behavioral: Low Starch Diet (LSD) |
| Control | Active comparator | Participants will receive dietary counselling based on general recommendations for healthy eating. Receives: Behavioral: General healthy eating |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in intestinal Klebsiella
To compare the mean change of Klebsiella bacteria in faecal samples between the LSD group and the control.
Measured: 6 weeks (at baseline and the end of follow-up between the two groups)
Change in mean erythrocyte sedimentation rate (ESR)
Plasma concentrations will be assessed to evaluate ESR, a marker of systemic inflammation that provided insights into the overall anti-inflammatory effect of rheumatologic therapies. Data are presented as mean ESR value in millimeters per hour (mm/hr) ± standard deviation.
Measured: 6 weeks (at baseline and the end of follow-up)
Change in mean C-reactive protein (CRP)
Plasma concentrations will be assessed to evaluate CRP, a marker of systemic inflammation that provided insights into the overall anti-inflammatory effect of rheumatologic therapies. Data are presented as mean CRP value in milligrams per liter (mg/L) ± standard deviation.
Measured: 6 weeks (at baseline and the end of follow-up)
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
The BASDAI is a six question, participant-reported measure of overall disease activity that probed the level of fatigue, neck/back/hip pain, peripheral joint swelling and pain, localized tenderness, as well as morning stiffness severity and duration. The mean measurement (score) of questions 5 and 6 is added to the scores from questions 1 to 4 and divided by 5 to calculate the total BASDAI score. It is scored on a numerical rating scale that ranges from 0 (no symptoms) to 10 (severe symptoms), higher scores indicating severe disability due to AS disease. Data are presented as mean total BASDAI score +/- standard deviation.
Measured: 6 weeks (at baseline and the end of follow-up)
Bath Ankylosing Spondylitis Function Index (BASFI)
The BASFI is a self-assessment instrument used to assess function. It comprises 8 specific questions regarding function in AS and 2 questions to identify participant's ability to cope up with everyday life. Each question is answered on a 100 millimeter (mm) horizontal VAS. The mean VAS score gives BASFI score between 0 to 100 where 0=easy to 100=impossible.
Measured: 6 weeks (at baseline and the end of follow-up)
Ankylosing Spondylitis Disease Activity Score (ASDAS)
ASDAS includes CRP mg/L; four additional self-reported items (rated on 0-10cm VAS or 0-10 numerical rating scale [NRS]) included are total back pain (TBP), duration of morning stiffness (DMS), peripheral pain/swelling and patient global assessment (PGA). ASDAS scores calculated as: ASDAS(CRP) = (0.121*total back pain) + (0.110*participant global) + (0.073*peripheral pain/swelling) + (0.058* duration of morning stiffness) + (0.579*Ln(CRP+1). The disease activity, TBP, and peripheral pain/swelling on a numeric rating scale (from 0 (normal) to 10 (very severe)) and DMS on a numeric rating scale (0 to 10, with 0 being none and 10 representing a duration of =>2 hours). Inactive disease is defined as an ASDAS score <1.3.
Measured: 6 weeks (at baseline and the end of follow-up)
Bath Ankylosing Spondylitis Patient Global Score (BAS-G)
The self-administered Bath Ankylosing Spondylitis Global (BAS-G) measures global consequences of axial spondyloarthritis, indicating the effect of disease on participant's well-being. This scale is composed of 2 items ranging from 0 = very good to 10 =very bad. Total score ranges from 0 to 10: the higher the BAS-G score, the worse the participant's health status.
Measured: 6 weeks (at baseline and the end of follow-up)
Ankylosing Spondylitis Quality of Life (ASQoL)
The Ankylosing Spondylitis Quality of Life (ASQoL) questionnaire is a disease-specific instrument designed to measure the health related quality of life (HRQOL) in participants with AS. Participants answer yes/no to 18 items assessing the current impact of AS on their quality of life status. The total score ranges from 0 to 18, with lower scores representing better AS-specific quality of life. Negative numbers indicate improvement from baseline.
Measured: 6 weeks (at baseline and the end of follow-up)
Euro Quality of Life-5D (EQ-5D)
The EQ-5D is a standardized, generic measure of health outcome, designed for self-completion by participants. The EQ-5D includes a descriptive section with 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) that are combined into an overall health utilities index, and an NRS (100 mm VAS) that measures perception of overall health, with 0 indicating worst health and 100 representing best imaginable health.
Measured: 6 weeks (at baseline, 2-weeks, 4-weeks, end of follow-up)
Change in Short Form (36) Health Survey (SF-36)
SF-36 is a generic 36-item questionnaire measuring health-related quality of life (HRQL) covering 2 summary measures: physical component summary (PCS) and mental component summary (MCS). The SF-36 consists of 8 subscales. The PCS had 4 subscales: physical function, role limitations due to physical problems, pain, and general health perception. The MCS had 4 subscales: vitality, social function, role limitations due to emotional problems, and mental health. Participants self-report on items in a subscale that have between 2-6 choices per item using Likert-type responses (e.g. none of the time, some of the time, etc.). Summations of item scores of the same subscale give the subscale scores, which are transformed into a range from 0 to 100; 0= worst HRQL, 100=best HRQL. Higher scores indicate better health and well-being.
Measured: 6 weeks (at baseline and the end of follow-up)
Change in ASAS response criteria
The Assessment in SpondyloArthritis international Society (ASAS) 20 response is defined as an improvement of >= 20% and absolute improvement of >= 1 unit (on a scale of 0 to 10) from Baseline in at least three of the following four domains, with no deterioration (where deterioration is defined as a worsening of >= 20% and a net worsening of >= 1 units [on a scale of 0 to 10]) in the remaining domains: Patient's Global Assessment, Pain, Function, Inflammation.
Measured: 6 weeks (at baseline and the end of follow-up)
Change in pain, fatigue and stiffness by patient's Visual analogue scale (VAS)
The VAS score assessed by participants, is used to determine the symptom (pain, fatigue and stiffness) impact due to AS in the past week. The level is measured in millimeters (mm) on a 100 mm horizontal line. The score ranges from 0 (no pain) to 100 (severe pain). Data are presented as mean VAS score +/- standard deviation.
Measured: 6 weeks (at baseline, 2-weeks, 4-weeks, end of follow-up)
Secondary outcomes (5)
Individual evolution of intestinal Klebsiella
To compare the average change of Klebsiella bacteria, quantified in colony-forming unit per gram of feces (cfu/gr) in faecal samples among each participant.
Measured: 6 weeks (at baseline, 2-weeks, 4-weeks, end of follow-up)
Change in Weight
To compare the average change in weight (kilograms) between LSD group and the controls, before and after the intervention.
Measured: 6 weeks (at baseline and the end of follow-up)
Change in body mass index (BMI)
To compare the average change in BMI (kg/m2), calculated by weight/(height^2), between LSD group and the controls, before and after the intervention.
Measured: 6 weeks (at baseline and the end of follow-up)
Change in body composition
To compare the average change in percentage of the evaluation of the body fat mass between LSD group and the controls, before and after the intervention.
Measured: 6 weeks (at baseline and the end of follow-up)
Quantification of the average starch intake through 24h dietary recall
To quantify the average starch dietetic content (in grams per day), determined through the 24h dietetic recall applied for 3 days, to calculate the ingested starch during the intervention and determine the respective individual percentage of average reduction.
Measured: 6 weeks (3 days of each week till the end of follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2020
- Study start3 Jan 2022
- Primary completion30 Sep 2022 (estimated)
- Study completion30 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SpondyloarthritisStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 150 participants (estimated)
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
- Principal investigator, Alexandra Cardoso, Universidade do Porto
- Investigators
- Alexandra MT Cardoso, MD, Principal investigator, Universidade do PortoMaria Leonor Silva, PhD, Study director, Centro de Investigação Interdisciplinar Egas MonizPatrícia Padrão, PhD, Study director, Universidade do Porto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04386538
- Sponsor's protocol ID
- alexandracardoso
- Status last verified
- Jan 2022
- First submitted
- 4 May 2020
- Last updated
- 25 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- 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 25 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Low Starch Diet in the Gut Microbiome Modulation, Disease Activity and Quality of Life in Patients With Ankylosing Spondylitis
- ClinicalTrials.gov ID
- NCT04386538
- Acronym / sponsor ID
- alexandracardoso
- Conditions
- Spondyloarthritis, Ankylosing Spondylitis
- Keywords
- Low Starch Diet (LSD), Klebsiella, Ankylosing Spondylitis, Disease activity, Quality of life, Nutrition, Diet therapy, Spondyloarthritis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Universidade do PortoUniversity, hospital or other
- Collaborators
- Portuguese Institute of Rheumatology, Centro de Investigação Interdisciplinar Egas Moniz
- Study start
- 3 Jan 2022 (actual)
- Primary completion
- 30 Sep 2022 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 13 May 2020 (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 explore the effect of a low starch diet (reduction of at least 40%) in the gut bacteria modulation, especially Klebsiella pneumoniae, and its relation to disease activity, functional impairment and quality of life in patients with Ankylosing Spondylitis (AS).
Detailed description
Ankylosing spondylitis (AS) is a chronic inflammatory rheumatic disease characterized by axial inflammation and with unknown aetiology. The immune system dysregulation is known, where genetic factors play a key role, in particular, the susceptibility associated to the HLA-B27 allele. The presence of this genetic marker, seems to trigger an abnormal response of the individual, under the action of determine microorganisms, and probably, the combination of these two factors may contribute to the manifestation of the disease, through the induction of an immune and cytolytic response, leading to tissue injury and promoting the inflammation. Intestinal microbiota involvement in spondylarthritis is a controversial issue, however, was observed an increased concentration of Klebsiella pneumoniae bacteria in the faeces of AS patients. It has been suggested that an intervention aiming these bacteria's starving could benefit the reduction of the inflammatory processes and be a part of AS treatment. The bowel microflora depends on dietary intake, like undigested starch, for their growth. Some studies have highlighted the relation between the intake of starch and the disease activity. The modulation of the microbiota, particularly, the reduction of Klebsiella, may be beneficial as a complementary approach to AS therapy.
A sample of 300 patients with AS, followed-up at Portuguese Institute of Rheumatology in Lisbon, will be randomly assigned in two groups. The group A will adopt a balanced diet based on the general recommendations for healthy eating by the World Health Organization, for a period of 6 weeks. In Group B will be implemented an individual balanced low starch diet, which is characterized by the significant reduction of starchy food, of at least 40% of the total daily ingested starch.
The change in biometric data, body composition, intestinal Klebsiella will be related to food intake, disease activity and quality of life assessments. These data will be compared between the 2 groups (diet A versus diet B), obtaining measures on the effect of each diet on the analyzed variables.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low Starch Diet (LSD) | Experimental | Behavioral: Low Starch Diet (LSD)Participants will receive the low starch diet program: restricts the daily amount of ingested rich starch food, to a reduction of at least 40% compared to usual daily individual starch intake. |
| Control | Active comparator | Behavioral: General healthy eatingParticipants will receive dietary counselling based on general recommendations for healthy eating. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age between 18 and 75 years old
- Available to comply with study protocol
- Ability to read and sign the Informed Consent
- Diagnosis of Ankylosing Spondylitis performed by the rheumatologist, according to the ASAS classification criteria, revised in 2016
- Positive HLA-B27allele
Key exclusion criteria (7 listed)
- Pregnant, breastfeeding or planning to become pregnant within the study period
- Prior or current clinical history of drug or other substances abuse
- Subjects with uncontrolled clinical conditions, like neoplastic diseases, renal failure, liver impairment, uncompensated cardiac disease
- Dietetic restrictions due to religious believes or others incompatible with the study protocol
- Impossibility to attend to the mandatory personal clinical evaluation
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 |
|---|---|---|
| Low Starch Diet (LSD)6-week balanced diet program, adapted to individual energetic needs, with significant reduction of high content starchy food, naturally present in plant cells, roots, tubers, seeds, beans, legumes, fruits, and highly present in most farinaceous grains, especially in potatoes, corn, rice, pasta, bread, cookies and cakes. | Behavioural | Low Starch Diet (LSD) |
| General healthy eating6-week balanced healthy eating counseling program, according to the World Health Organization recommendations. | Behavioural | Control |
Primary outcome
Change in intestinal Klebsiella
Time frame: 6 weeks (at baseline and the end of follow-up between the two groups)
To compare the mean change of Klebsiella bacteria in faecal samples between the LSD group and the control.
Change in mean erythrocyte sedimentation rate (ESR)
Time frame: 6 weeks (at baseline and the end of follow-up)
Plasma concentrations will be assessed to evaluate ESR, a marker of systemic inflammation that provided insights into the overall anti-inflammatory effect of rheumatologic therapies. Data are presented as mean ESR value in millimeters per hour (mm/hr) ± standard deviation.
Change in mean C-reactive protein (CRP)
Time frame: 6 weeks (at baseline and the end of follow-up)
Plasma concentrations will be assessed to evaluate CRP, a marker of systemic inflammation that provided insights into the overall anti-inflammatory effect of rheumatologic therapies. Data are presented as mean CRP value in milligrams per liter (mg/L) ± standard deviation.
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
Time frame: 6 weeks (at baseline and the end of follow-up)
The BASDAI is a six question, participant-reported measure of overall disease activity that probed the level of fatigue, neck/back/hip pain, peripheral joint swelling and pain, localized tenderness, as well as morning stiffness severity and duration. The mean measurement (score) of questions 5 and 6 is added to the scores from questions 1 to 4 and divided by 5 to calculate the total BASDAI score. It is scored on a numerical rating scale that ranges from 0 (no symptoms) to 10 (severe symptoms), higher scores indicating severe disability due to AS disease. Data are presented as mean total BASDAI score +/- standard deviation.
Bath Ankylosing Spondylitis Function Index (BASFI)
Time frame: 6 weeks (at baseline and the end of follow-up)
The BASFI is a self-assessment instrument used to assess function. It comprises 8 specific questions regarding function in AS and 2 questions to identify participant's ability to cope up with everyday life. Each question is answered on a 100 millimeter (mm) horizontal VAS. The mean VAS score gives BASFI score between 0 to 100 where 0=easy to 100=impossible.
Ankylosing Spondylitis Disease Activity Score (ASDAS)
Time frame: 6 weeks (at baseline and the end of follow-up)
ASDAS includes CRP mg/L; four additional self-reported items (rated on 0-10cm VAS or 0-10 numerical rating scale [NRS]) included are total back pain (TBP), duration of morning stiffness (DMS), peripheral pain/swelling and patient global assessment (PGA). ASDAS scores calculated as: ASDAS(CRP) = (0.121*total back pain) + (0.110*participant global) + (0.073*peripheral pain/swelling) + (0.058* duration of morning stiffness) + (0.579*Ln(CRP+1). The disease activity, TBP, and peripheral pain/swelling on a numeric rating scale (from 0 (normal) to 10 (very severe)) and DMS on a numeric rating scale (0 to 10, with 0 being none and 10 representing a duration of =>2 hours). Inactive disease is defined as an ASDAS score <1.3.
Bath Ankylosing Spondylitis Patient Global Score (BAS-G)
Time frame: 6 weeks (at baseline and the end of follow-up)
The self-administered Bath Ankylosing Spondylitis Global (BAS-G) measures global consequences of axial spondyloarthritis, indicating the effect of disease on participant's well-being. This scale is composed of 2 items ranging from 0 = very good to 10 =very bad. Total score ranges from 0 to 10: the higher the BAS-G score, the worse the participant's health status.
Ankylosing Spondylitis Quality of Life (ASQoL)
Time frame: 6 weeks (at baseline and the end of follow-up)
The Ankylosing Spondylitis Quality of Life (ASQoL) questionnaire is a disease-specific instrument designed to measure the health related quality of life (HRQOL) in participants with AS. Participants answer yes/no to 18 items assessing the current impact of AS on their quality of life status. The total score ranges from 0 to 18, with lower scores representing better AS-specific quality of life. Negative numbers indicate improvement from baseline.
Euro Quality of Life-5D (EQ-5D)
Time frame: 6 weeks (at baseline, 2-weeks, 4-weeks, end of follow-up)
The EQ-5D is a standardized, generic measure of health outcome, designed for self-completion by participants. The EQ-5D includes a descriptive section with 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) that are combined into an overall health utilities index, and an NRS (100 mm VAS) that measures perception of overall health, with 0 indicating worst health and 100 representing best imaginable health.
Change in Short Form (36) Health Survey (SF-36)
Time frame: 6 weeks (at baseline and the end of follow-up)
SF-36 is a generic 36-item questionnaire measuring health-related quality of life (HRQL) covering 2 summary measures: physical component summary (PCS) and mental component summary (MCS). The SF-36 consists of 8 subscales. The PCS had 4 subscales: physical function, role limitations due to physical problems, pain, and general health perception. The MCS had 4 subscales: vitality, social function, role limitations due to emotional problems, and mental health. Participants self-report on items in a subscale that have between 2-6 choices per item using Likert-type responses (e.g. none of the time, some of the time, etc.). Summations of item scores of the same subscale give the subscale scores, which are transformed into a range from 0 to 100; 0= worst HRQL, 100=best HRQL. Higher scores indicate better health and well-being.
Change in ASAS response criteria
Time frame: 6 weeks (at baseline and the end of follow-up)
The Assessment in SpondyloArthritis international Society (ASAS) 20 response is defined as an improvement of >= 20% and absolute improvement of >= 1 unit (on a scale of 0 to 10) from Baseline in at least three of the following four domains, with no deterioration (where deterioration is defined as a worsening of >= 20% and a net worsening of >= 1 units [on a scale of 0 to 10]) in the remaining domains: Patient's Global Assessment, Pain, Function, Inflammation.
Change in pain, fatigue and stiffness by patient's Visual analogue scale (VAS)
Time frame: 6 weeks (at baseline, 2-weeks, 4-weeks, end of follow-up)
The VAS score assessed by participants, is used to determine the symptom (pain, fatigue and stiffness) impact due to AS in the past week. The level is measured in millimeters (mm) on a 100 mm horizontal line. The score ranges from 0 (no pain) to 100 (severe pain). Data are presented as mean VAS score +/- standard deviation.
5 secondary outcomes
Individual evolution of intestinal Klebsiella
Time frame: 6 weeks (at baseline, 2-weeks, 4-weeks, end of follow-up)
Change in Weight
Time frame: 6 weeks (at baseline and the end of follow-up)
Change in body mass index (BMI)
Time frame: 6 weeks (at baseline and the end of follow-up)
Change in body composition
Time frame: 6 weeks (at baseline and the end of follow-up)
Quantification of the average starch intake through 24h dietary recall
Time frame: 6 weeks (3 days of each week till the end of follow-up)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2022.
- 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.
Alexandra MT Cardoso, MD principal investigator
Universidade do Porto
Maria Leonor Silva, PhD study director
Centro de Investigação Interdisciplinar Egas Moniz
Patrícia Padrão, PhD study director
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 Low Starch Diet (LSD) and General healthy eating in people with Spondyloarthritis and Ankylosing Spondylitis, 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 6 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 25 Jan 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alexandra MT Cardoso, MD (+351926142356, alexandra.cardoso@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in intestinal Klebsiella (time frame: 6 weeks (at baseline and the end of follow-up between the two groups)). The study lists 12 primary outcomes in all. 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 25 Jan 2022.