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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Immune Response Regulation and Nutritional Status of Crohn's Disease Patients Under Anti-TNF-alpha and Azathioprine Therapy.

Conditions
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Crohn's Disease

Intervention / Treatment
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* Dietary Supplement: Whey protein
* Dietary Supplement: Soy protein


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Whey protein<br>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. | Dietary Supplement: Whey protein<br>* 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.<br>|
| Active Comparator: Soy protein<br>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. | Dietary Supplement: Soy protein<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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). | 16 weeks | 
| Mid-arm circumference | Mid-arm circumference was obtained using the tape measure. | 16 weeks | 
| Mid-arm muscle circumference | Mid-arm muscle circumference was calculated from mid-arm circumference and triceps skin fold thickness. | 16 weeks | 
| Corrected arm muscle area | Corrected arm muscle area was calculated from mid-arm circumference and triceps skin fold thickness. | 16 weeks | 
| Crohn's Disease Activity Index | The Crohn's Disease Activity Index was used for evaluation of disease activity. | 16 weeks | 
| C-reactive protein |  | 16 weeks | 
| Serum albumin |  | 16 weeks | 
| Pre-albumin |  | 16 weeks | 
| Triceps skin fold thickness | Triceps skin fold thickness was obtained using the Lange skin fold caliper. | 16 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Crohn's disease, whey protein, soy protein, nutritional status, activity of disease