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

Crohn's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01957423
• Other study ID #: CAAE: 1099.0.146.000-11
• Status: Completed
• Phase: N/A
• First received: September 24, 2013
• Last updated: September 30, 2013
• Start date: March 2012
• Est. completion date: March 2013

Study information

• Verified date: September 2013
• Source: University of Campinas, Brazil
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease

Intervention

Dietary Supplement:
• 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 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.

Locations

Country	Name	City	State
Brazil	University of Campinas	Campinas	Sao Paulo

Sponsors (2)

Lead Sponsor	Collaborator
University of Campinas, Brazil	Fundação de Amparo à Pesquisa do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Mid-arm circumference	Mid-arm circumference was obtained using the tape measure.	16 weeks	No
Secondary	Mid-arm muscle circumference	Mid-arm muscle circumference was calculated from mid-arm circumference and triceps skin fold thickness.	16 weeks	No
Secondary	Corrected arm muscle area	Corrected arm muscle area was calculated from mid-arm circumference and triceps skin fold thickness.	16 weeks	No
Secondary	Crohn's Disease Activity Index	The Crohn's Disease Activity Index was used for evaluation of disease activity.	16 weeks	No
Secondary	C-reactive protein		16 weeks	No
Secondary	Serum albumin		16 weeks	No
Secondary	Pre-albumin		16 weeks	No
Secondary	Triceps skin fold thickness	Triceps skin fold thickness was obtained using the Lange skin fold caliper.	16 weeks	No