Crohn's disease: effect of nutrition supplements on Disease Activity Index (CDAI) and nutritional state of the patients in therapy with anti-TNF-alpha and Azathioprine.

Abstract

Crohn's disease (CD) is a chronic inflammatory disease that may affect any part of the gastrointestinal tract. During the acute phase, the digestive symptoms can lead to malnutrition, which often complicate the disease. However, in the disease remission phase some patients show overweight or obesity; adipose tissue produces pro-inflammatory cytokines, that can make disease problems worse. Reports showed that bovine whey protein may improve body composition (increase lean tissue and decrease adipose tissue) and exhibit immunoregulatory effects. The positive effects mentioned and anti-inflammatory outcome from TGF-² cytokine assist in maintenance of disease remission, reducing inflammation and digestive symptoms, providing quality-of-life and enhancing the nutritional status of patients. The present study will evaluate the effects of the application of a supplement composed of bovine whey protein enriched with TGF-² on Crohn's Disease Activity Index (CDAI) and nutritional status of persons with CD. The study will be a prospective, double-blind, placebo-controlled clinical trial. The patients will be randomly split in two groups: one group supplemented with 30g of whey protein concentrate and the other with soy protein isolate (placebo). Supplement compliance will be assessed by means of a questionary applied to each patient in a interview. Nutritional status will be assessed before, during and after the sixteen week supplementation period, by anthropometry, bioimpedance, 24-hour dietary recall and dosage of serum albumin and pre-albumin.