Protein oxidation in stable renal transplant patients measured with a breath test

Withdrawn

• Conditions: protein oxidation; 10037008

• Registration Number: NL-OMON46350
• Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 11 June 2024

Recruitment & Eligibility

• Status: Withdrawn
• Sex: Not specified
• Target Recruitment: 32

Inclusion Criteria

- Age 18+
- Male
- Be able to consume a 500 ml test drink within 5 minutes
- Be able to speak the Dutch language
- Give written consent
- For renal transplant patients: received renal transplant >6 months before the study
- For renal transplant patients: stable medication schedule for >2 weeks before the study (e.g. steroid use)
- For healthy subjects: donated kidney >6 months before the study

Exclusion Criteria

- Milk (protein) allergy or intolerance
- Diabetes
- Cancer, except skin cancer
- Recreational drug use
- Active infection (CRP >10)
- Habitual average intake of more than 2 glasses of alcohol per day
- Not able to stop alcohol consumption 2 days before the test
- BMI <20 and >35
- Vegetarianism

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The total protein oxidation measured with the breath test over 330 minutes in<br /><br>both groups will be compared to answer our main research question.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Multiple co-variates will be used in the statistical analysis<br /><br>Physical properties: bodyweight, Body Mass Index, Resting Metabolic Rate,<br /><br>fat-free mass<br /><br>From the food diary: energy intake and protein intake<br /><br>From 24-hour urine (medical dossier): urea (measure for protein intake) and<br /><br>creatinine (measure for muscle mass)<br /><br>From blood: glucose, insulin, CRP and IGF-1</p><br>