Immune Response Regulation and Nutritional Status of the Crohn's Disease Patients.
- Conditions
- Crohn's Disease
- Registration Number
- NCT01957423
- Lead Sponsor
- University of Campinas, Brazil
- Brief Summary
The objective of this study was to evaluate the effect of Whey Protein (WP) and Soy Protein (SP) nutritional supplements on nutritional status and disease activity in Crohn's disease patients.
- Detailed Description
The patients were split into two groups: one group was supplemented with whey protein and the other, with soy protein. Participants were assessed at three moments: before starting the intervention and after 8 and 16 weeks. The nutritional status and body composition were measured using bioimpedance analysis, anthropometry and albumin and pre-albumin dosages. Dietary intake was determined by 24-h dietary recalls. The disease activity was evaluated by Crohn's Disease Activity Index, serum cytokines and C-reactive protein dosages.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 41
- Crohn's disease patients treated with azathioprine or anti-tumor necrosis factor-alpha (anti-TNF-alpha) or azathioprine and anti-TNF-alpha
- smokers
- who were using other medication or nutritional supplements.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Body mass index 16 weeks Body mass index (BMI) was calculated from weight and height (kilograms per meter squared) and classified according to the World Health Organization.
- Secondary Outcome Measures
Name Time Method Body fat percentage 16 weeks Body fat was measured using bioimpedance analysis. Whole-body resistance and reactance were measured using a tetrapolar bioelectrical impedance analyzer in accordance with the manufacturer's guidelines (BIODYNAMICS, Model 310e).
Body lean percentage 16 weeks The body lean mass was measured using bioimpedance analysis. Whole-body resistance and reactance were measured using a tetrapolar bioelectrical impedance analyzer in accordance with the manufacturer's guidelines (BIODYNAMICS, Model 310e).
Mid-arm circumference 16 weeks Mid-arm circumference was obtained using the tape measure.
Mid-arm muscle circumference 16 weeks Mid-arm muscle circumference was calculated from mid-arm circumference and triceps skin fold thickness.
Corrected arm muscle area 16 weeks Corrected arm muscle area was calculated from mid-arm circumference and triceps skin fold thickness.
Crohn's Disease Activity Index 16 weeks The Crohn's Disease Activity Index was used for evaluation of disease activity.
C-reactive protein 16 weeks Serum albumin 16 weeks Pre-albumin 16 weeks Triceps skin fold thickness 16 weeks Triceps skin fold thickness was obtained using the Lange skin fold caliper.
Trial Locations
- Locations (1)
University of Campinas
🇧🇷Campinas, Sao Paulo, Brazil
University of Campinas🇧🇷Campinas, Sao Paulo, Brazil