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Effect of the Mediterranean diet on state inflammatory, lung function and quality of life of patients with cystic fibrosis: randomized controlled trial

Effect of the Mediterranean diet on state inflammatory, lung function and quality of life of patients with cystic fibrosis: randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-8d26mf
Enrollment
Unknown
Registered
2015-09-30
Start date
2015-11-01
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cystic fibrosis Nutritional status

Interventions

Intervention group : 20 patients with cystic fibrosis will receive follow-up guidance Mediterranean diet for 4 months . Control group: 20 patients with cystic fibrosis will be guided to standard diet
Dietary supplement

Sponsors

Universidade Federal do Rio Grande do Sul
Lead Sponsor
Hospital de Clínicas de Porto Alegre
Collaborator

Eligibility

Age
6 Years to 18 Years

Inclusion criteria

Inclusion criteria: Patients diagnosed with cystic fibrosis (n=40) confirmed by two tests dosage Na and Cl in the identification or sweat 2 mutations known to be related to illness and aged 6-18 years.

Exclusion criteria

Exclusion criteria: Patients with advanced lung disease (FEV1 < 40%); Patients using oral corticosteroids in the last two months and inability to perform pulmonary function tests.

Design outcomes

Primary

MeasureTime frame
Reduction of the dosage of an inflammatory state in the period of 4 months , verified by C-reactive protein dosage and interleukin 1_B , 6, 8, 10 and 17 using a customized test the Multiplex based on the observation of a variation of at least 5 % in pre and post intervention measurements .

Secondary

MeasureTime frame
Increased lung function during the period of four months, verified by the analysis of FEV1 by spirometry from the realization of a range of at least 2% in pre and post intervention measurements. Increased quality of life in the period of four months, measured by questionnaire specific quality of life for FC from the realization of a range of at least 5% in pre and post intervention measurements. Improved fitness in the four months period measured by the walking test from the realization of a range of at least 5% in pre and post intervention measurements. Improvement in general evaluation parameters of the disease in the period of 4 months, as measured by the Shwachman-Kulczycki score from the realization of a range of at least 5% in pre and post intervention measurements. Reducing the frequency of pulmonary exacerbations in the period of four months, measured by the number of days with antibiotics from the realization of a range of at least 5% in pre and post intervention measurements. Increased antioxidant status in 4 month period measured by the dosage serum albumin Based on the observation of a variation of at least 5% in pre and post intervention measurements.

Countries

Brazil

Contacts

Public ContactPaulo Maróstica

Hospital de Clínicas de Porto Alegre

pmarostica@hcpa.edu.br555133598515

Outcome results

None listed

Source: REBEC (via WHO ICTRP)