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

Primary Purpose

Crohn's Disease

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Whey protein
Soy protein
Sponsored by
University of Campinas, Brazil
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Crohn's Disease focused on measuring Crohn's disease, whey protein, soy protein, nutritional status, activity of disease

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Campinas

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Whey protein

Soy protein

Arm Description

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 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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
September 24, 2013
Last Updated
September 30, 2013
Sponsor
University of Campinas, Brazil
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT01957423
Brief Title
Immune Response Regulation and Nutritional Status of the Crohn's Disease Patients.
Official Title
Immune Response Regulation and Nutritional Status of Crohn's Disease Patients Under Anti-TNF-alpha and Azathioprine Therapy.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Campinas, Brazil
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn's Disease
Keywords
Crohn's disease, whey protein, soy protein, nutritional status, activity of disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Whey protein
Arm Type
Experimental
Arm Description
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.
Arm Title
Soy protein
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Whey protein
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Soy protein
Intervention Description
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 Measure Information:
Title
Body mass index
Description
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 Outcome Measure Information:
Title
Body fat percentage
Description
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
Title
Body lean percentage
Description
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
Title
Mid-arm circumference
Description
Mid-arm circumference was obtained using the tape measure.
Time Frame
16 weeks
Title
Mid-arm muscle circumference
Description
Mid-arm muscle circumference was calculated from mid-arm circumference and triceps skin fold thickness.
Time Frame
16 weeks
Title
Corrected arm muscle area
Description
Corrected arm muscle area was calculated from mid-arm circumference and triceps skin fold thickness.
Time Frame
16 weeks
Title
Crohn's Disease Activity Index
Description
The Crohn's Disease Activity Index was used for evaluation of disease activity.
Time Frame
16 weeks
Title
C-reactive protein
Time Frame
16 weeks
Title
Serum albumin
Time Frame
16 weeks
Title
Pre-albumin
Time Frame
16 weeks
Title
Triceps skin fold thickness
Description
Triceps skin fold thickness was obtained using the Lange skin fold caliper.
Time Frame
16 weeks

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria MS Vilela, MD PhD
Organizational Affiliation
University of Campinas
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Campinas
City
Campinas
State/Province
Sao Paulo
ZIP/Postal Code
13083-970
Country
Brazil

12. IPD Sharing Statement

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

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