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Completed

NCT Number: NCT01957423

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

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.

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Key information

Conditions

Crohn's Disease Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Campinas

Campinas, São Paulo, 13083-970, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Body mass index

    Time frame: 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 outcomes

  1. Body fat percentage

    Time frame: 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).

  2. Body lean percentage

    Time frame: 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).

  3. Mid-arm circumference

    Time frame: 16 weeks

    Mid-arm circumference was obtained using the tape measure.

  4. Mid-arm muscle circumference

    Time frame: 16 weeks

    Mid-arm muscle circumference was calculated from mid-arm circumference and triceps skin fold thickness.

  5. Corrected arm muscle area

    Time frame: 16 weeks

    Corrected arm muscle area was calculated from mid-arm circumference and triceps skin fold thickness.

  6. Crohn's Disease Activity Index

    Time frame: 16 weeks

    The Crohn's Disease Activity Index was used for evaluation of disease activity.

  7. C-reactive protein

    Time frame: 16 weeks

  8. Serum albumin

    Time frame: 16 weeks

  9. Pre-albumin

    Time frame: 16 weeks

  10. Triceps skin fold thickness

    Time frame: 16 weeks

    Triceps skin fold thickness was obtained using the Lange skin fold caliper.

Sponsors and collaborators

Lead sponsor

University of Campinas, Brazil

Other

Collaborators

  • Fundação de Amparo à Pesquisa do Estado de São Paulo

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Oct 8, 2013
Registry last updated
Oct 8, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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