NCT04386538

Effect of a Low Starch Diet in Patients With Ankylosing Spondylitis

Effect of a Low Starch Diet in the Gut Microbiome Modulation, Disease Activity and Quality of Life in Patients With Ankylosing Spondylitis

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Universidade do Porto · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
BEHAVIORAL	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.
BEHAVIORAL	General healthy eating	6-week balanced healthy eating counseling program, according to the World Health Organization recommendations.

Timeline

• Start date: 2022-01-03
• Primary completion: 2022-09-30
• Completion: 2022-12-30
• First posted: 2020-05-13
• Last updated: 2022-01-25

Locations

1 site across 1 country: Portugal