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van CCT (UK)


Measure protein metabolism via a breath test.


- candidate number25311
- NTR NumberNTR6101
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR19-sep-2016
- Secondary IDsMETc 2016.144  METc commissie UMCG
- Public TitleMeasure protein metabolism via a breath test.
- Scientific TitleThe influence of different levels of protein on 13C-protein oxidation measured via breath test.
- ACRONYMPOS
- hypothesisProtein metabolism consists of amino acid incorporation and amino acid oxidation. We have developed a breath test which is able to measure the oxidation of ingested 13C-protein. We hypothesize that a diet low in protein before the breath test will result in a shortage of protein the body. During the test we expect to measure less 13C-protein to be oxidized compared to a normal protein diet.
- Healt Condition(s) or Problem(s) studiedProtein, Respiration
- Inclusion criteriaHealthy volunteers:
Male
Age between 18 - 30
- Exclusion criteria- Disease and/or being medically treated (e.g. diabetes mellitus)
- Milk (protein) allergy or intolerance
- Smoking
- Drug use
- Alcoholism, and no alcohol during the 4-day diets
- Waist circumference ≥102 cm
- Vegetarian
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupCrossover
- Type[default]
- Studytypeintervention
- planned startdate 1-sep-2016
- planned closingdate1-dec-2016
- Target number of participants16
- Interventions4 days of high protein diet (1,35 g protein / kg bodyweight /day) at habitual energy intake followed on day 5 by the protein oxidation breath test.
4 days of medium protein diet (0,8 g protein / kg bodyweight /day) at habitual energy intake followed on day 5 by the protein oxidation breath test.
4 days of low protein diet (0,25 g protein / kg bodyweight /day) at habitual energy intake followed on day 5 by the protein oxidation breath test.
- Primary outcomeTotal 13C-protein oxidation measured by the breath test over 5,5 hours.
- Secondary outcome4-day food diaries. 1 for baseline measurement of habitual energy and protein intake. The other three for the different interventions.
24-hour urine collection for measuring urea (protein intake) and creatinine (muscle mass)
- TimepointsBaseline breath sample at t = -5 minutes 30 g 13C-protein in 500 ml water consumption at t = 0 (09:15) Breath samples every ten minutes starting at 09:25 untill 14:45
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESMSc Gerlof Reckman
- CONTACT for SCIENTIFIC QUERIESMSc Gerlof Reckman
- Sponsor/Initiator University Medical Center Groningen (UMCG)
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- Publications
- Brief summaryResearching protein oxidation in a non-invasive way could be an interesting approach to perform more research on protein metabolism. Our 30 gram 13C-protein breath test enables us to measure protein oxidation over 5,5 hours. With the knowledge that protein metabolism consists mainly of primarily incorporation of amino acids and secondarily oxidation of surplus amino acids we can make statements about total protein metabolism. In this trial, we will measure the effects of subjects' habitual diets (rich in protein, average 1.15 g protein/kg bw/ day) versus a 4-day low protein diet (0.25 g protein/kg bw/day) on the protein oxidation measured bythe breath test performed on the fifth day. We expect to measure less of the 30 g protein being oxidized after a 4-day low protein diet compared to their habitual diet, similar to results aquired during our pilot experiment.
- Main changes (audit trail)
- RECORD19-sep-2016 - 7-feb-2017


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