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Immune Response Regulation and Nutritional Status of the Crohn's Disease Patients.

Not Applicable
Completed
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
Inclusion Criteria
  • Crohn's disease patients treated with azathioprine or anti-tumor necrosis factor-alpha (anti-TNF-alpha) or azathioprine and anti-TNF-alpha
Exclusion Criteria
  • smokers
  • who were using other medication or nutritional supplements.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Body mass index16 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
NameTimeMethod
Body fat percentage16 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 percentage16 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 circumference16 weeks

Mid-arm circumference was obtained using the tape measure.

Mid-arm muscle circumference16 weeks

Mid-arm muscle circumference was calculated from mid-arm circumference and triceps skin fold thickness.

Corrected arm muscle area16 weeks

Corrected arm muscle area was calculated from mid-arm circumference and triceps skin fold thickness.

Crohn's Disease Activity Index16 weeks

The Crohn's Disease Activity Index was used for evaluation of disease activity.

C-reactive protein16 weeks
Serum albumin16 weeks
Pre-albumin16 weeks
Triceps skin fold thickness16 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

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