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| Name | Class |
|---|---|
| Fundação de Amparo à Pesquisa do Estado de São Paulo | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Whey protein | Experimental | 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 | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Whey protein | Dietary Supplement | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maria MS Vilela, MD PhD | University of Campinas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Campinas | Campinas | São Paulo | 13083-970 | Brazil |
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| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D000067816 | Whey Proteins |
| D030262 | Soybean Proteins |
| ID | Term |
|---|---|
| D008894 | Milk Proteins |
| D000080224 | Animal Proteins, Dietary |
| D004044 | Dietary Proteins |
| D011506 | Proteins |
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|
| Soy protein | Dietary Supplement | 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. |
|
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 |
| D007410 | Intestinal Diseases |
| D000602 |
| Amino Acids, Peptides, and Proteins |
| D000067796 | Whey |
| D008892 | Milk |
| D003611 | Dairy Products |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
| D010940 | Plant Proteins |
| D014674 | Plant Proteins, Dietary |
| D045730 | Soy Foods |
| D000067075 | Vegetable Products |
| D014675 | Vegetables |