Crohn's Disease
Conditions
Keywords
Crohn's disease, whey protein, soy protein, nutritional status, activity of disease
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.
Interventions
DIETARY_SUPPLEMENTWhey 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.
DIETARY_SUPPLEMENTSoy 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.
Sponsors
Fundação de Amparo à Pesquisa do Estado de São Paulo
University of Campinas, Brazil
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Body mass index | 16 weeks | Body mass index (BMI) was calculated from weight and height (kilograms per meter squared) and classified according to the World Health Organization. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Body lean percentage | 16 weeks | 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 | 16 weeks | Mid-arm circumference was obtained using the tape measure. |
| Mid-arm muscle circumference | 16 weeks | Mid-arm muscle circumference was calculated from mid-arm circumference and triceps skin fold thickness. |
| Corrected arm muscle area | 16 weeks | Corrected arm muscle area was calculated from mid-arm circumference and triceps skin fold thickness. |
| Body fat percentage | 16 weeks | 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). |
| C-reactive protein | 16 weeks | — |
| Serum albumin | 16 weeks | — |
| Pre-albumin | 16 weeks | — |
| Triceps skin fold thickness | 16 weeks | Triceps skin fold thickness was obtained using the Lange skin fold caliper. |
| Crohn's Disease Activity Index | 16 weeks | The Crohn's Disease Activity Index was used for evaluation of disease activity. |
Countries
Brazil
Outcome results
None listed