Effect of a Low Starch Diet in Patients With Ankylosing Spondylitis

NCT ID: NCT04386538

Last Updated: 2022-01-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-03
• Study Completion Date: 2022-12-30

Brief 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).

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Low Starch Diet (LSD)

Intervention Type: BEHAVIORAL

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.

Control

Participants will receive dietary counselling based on general recommendations for healthy eating.

Group Type: ACTIVE_COMPARATOR

General healthy eating

Intervention Type: BEHAVIORAL

6-week balanced healthy eating counseling program, according to the World Health Organization recommendations.

Interventions

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.

Intervention Type: BEHAVIORAL

General healthy eating

6-week balanced healthy eating counseling program, according to the World Health Organization recommendations.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Portuguese Institute of Rheumatology

UNKNOWN

Sponsor Role: collaborator

Centro de Investigação Interdisciplinar Egas Moniz

UNKNOWN

Sponsor Role: collaborator

Universidade do Porto

OTHER

Sponsor Role: lead

Responsible Party

Alexandra Cardoso

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alexandra MT Cardoso, MD

Role: PRINCIPAL_INVESTIGATOR

Universidade do Porto

Maria Leonor Silva, PhD

Role: STUDY_DIRECTOR

Centro de Investigação Interdisciplinar Egas Moniz

Patrícia Padrão, PhD

Role: STUDY_DIRECTOR

Universidade do Porto

Locations

Instituto Português de Reumatologia

Lisbon, , Portugal

Site Status: RECRUITING

Countries

Portugal

Central Contacts

Alexandra MT Cardoso, MD

Role: CONTACT

alexandra.cardoso@gmail.com

+351926142356

Facility Contacts

Alexandra Cardoso, MD

Role: primary

alexandra.cardoso@gmail.com

+351926142356

Other Identifiers

alexandracardoso

Identifier Type: -

Identifier Source: org_study_id