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

N/ACompletedNCT01957423

University of Campinas, Brazil41 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Crohn's Disease

Interventions

Whey proteinDIETARY_SUPPLEMENT

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 proteinDIETARY_SUPPLEMENT

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.

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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.

Locations (1)

University of Campinas

Campinas, São Paulo, Brazil

Outcomes

Primary Outcomes

Body mass index

Body mass index (BMI) was calculated from weight and height (kilograms per meter squared) and classified according to the World Health Organization.

Time frame: 16 weeks

Secondary Outcomes

Body fat percentage

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).

Time frame: 16 weeks

Body lean percentage

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).

Time frame: 16 weeks

Mid-arm circumference

Mid-arm circumference was obtained using the tape measure.

Time frame: 16 weeks

Mid-arm muscle circumference

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

Time frame: 16 weeks

Corrected arm muscle area

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

Time frame: 16 weeks

Crohn's Disease Activity Index

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

Time frame: 16 weeks

Data from ClinicalTrials.gov

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