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

University of Campinas, Brazil

Status: Completed

Conditions: Crohn's Disease

Treatments: Dietary Supplement: Soy protein; Dietary Supplement: Whey protein

Study type: Interventional

Funder types: Other

Identifiers

NCT01957423

CAAE: 1099.0.146.000-11

Details and patient eligibility

About

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.

Full 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.

Enrollment: 41 patients

Sex: All

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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41 participants in 2 patient groups

Whey protein

Experimental group

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.

Treatment:

Dietary Supplement: Whey protein

Soy protein

Active Comparator group

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.

Treatment:

Dietary Supplement: Soy protein