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

Not Applicable

Completed

• Conditions: Crohn's Disease
• Interventions: Dietary Supplement: Whey protein; Dietary Supplement: Soy protein

• 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.

Study Timeline

• Study Start: 2012-03
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Status Verified: 2013-09
• Study First Submitted: 2013-09-24
• Study First Submitted QC: 2013-09-30
• Last Update Submitted: 2013-09-30
• Study First Posted: 2013-10-08
• Last Update Posted: 2013-10-08

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

Arm && Interventions

Group	Intervention	Description
Whey protein	Whey protein	Whey protein was provided as sachets with 15g. Patients were advised to consume two sachets per day (amounting to 22.4g of protein) mixed with food or a cold beverage, for 16 weeks. All patients remained on an unrestricted diet and did not receive nutritional advice.
Soy protein	Soy protein	Soy protein was provided as sachets with 15g. Patients were advised to consume two sachets per day (amounting to 22.4g of protein) mixed with food or a cold beverage, for 16 weeks. All patients remained on an unrestricted diet and did not receive nutritional advice.

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
Mid-arm muscle circumference	16 weeks	Mid-arm muscle circumference was calculated from mid-arm circumference and triceps skin fold thickness.
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.
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