Immune Response Regulation and Nutritional Status of the Crohn's Disease Patients.
1 other identifier
interventional
41
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2013
CompletedFirst Submitted
Initial submission to the registry
September 24, 2013
CompletedFirst Posted
Study publicly available on registry
October 8, 2013
CompletedOctober 8, 2013
September 1, 2013
1 year
September 24, 2013
September 30, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (10)
Body fat percentage
16 weeks
Body lean percentage
16 weeks
Mid-arm circumference
16 weeks
Mid-arm muscle circumference
16 weeks
Corrected arm muscle area
16 weeks
- +5 more secondary outcomes
Study Arms (2)
Whey protein
EXPERIMENTALWhey 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 COMPARATORSoy 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.
Interventions
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 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.
Eligibility Criteria
You may qualify if:
- Crohn's disease patients treated with azathioprine or anti-tumor necrosis factor-alpha (anti-TNF-alpha) or azathioprine and anti-TNF-alpha
You may not qualify if:
- smokers
- who were using other medication or nutritional supplements.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Campinas
Campinas, São Paulo, 13083-970, Brazil
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Maria MS Vilela, MD PhD
University of Campinas
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD
Study Record Dates
First Submitted
September 24, 2013
First Posted
October 8, 2013
Study Start
March 1, 2012
Primary Completion
March 1, 2013
Study Completion
March 1, 2013
Last Updated
October 8, 2013
Record last verified: 2013-09