Clinical trial NCT01314040: Study to Identify Biomarkers for Protein Intake
Official title: Study to Identify Biomarkers for Protein Intake; a Randomized, Fully Controlled Feeding Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Identify New Biomarkers in Blood or Urine After Consumption of Meat Protein, Dairy Protein and Grain Protein in Healthy Subjects.
Keywords: Dietary protein
Biomarkers
filtration rate
urinary acid excretion
Lead sponsor: Wageningen University
Sponsor class: OTHER
Collaborators: name: Top Institute Food and Nutrition
First posted: 2011-03-14
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: Results from observational studies suggest a small beneficial association between protein and blood pressure that may be mainly attributable to the intake of protein from plant sources. In epidemiological studies biomarkers of dietary intake are useful to estimate intake more reliably. Dietary studies using biomarkers of protein intake generally show stronger associations with health outcomes. However, data on biomarkers for specific types of protein (e.g. from dairy, meat, grain and legumes) are scarce. Therefore the purpose of this study is to identify new biomarkers for the intake of protein from meat, dairy and grain. In addition the secondary purpose is to investigate whether intake of protein from these sources influences kidney filtration rate and urinary acid excretion differentially.


Eligibility criteria: Inclusion Criteria:

* Age 18-40 years
* BMI between 18.5 and 30 kg/m2
* Healthy (As judged by the participant)
* Written informed consent obtained

Exclusion Criteria:

* Unable or unwilling to comply with study procedures.
* Unusual dietary patterns, including high alcohol intakes (≥ 2 glasses/day) and a vegetarian diet
* Recent (\< 4 weeks) or current participation in a study with any investigational drug or dietary intervention
* Usage of an energy restricted diet during the last two months
* Weight loss or weight gain of 5 kg or more during the last two months
* Smoking
* Stomach or bowel diseases
* Kidney disorders
* Diabetes, thyroid disease, other endocrine disorders
* Prevalent cardiovascular disease
* Extreme sports (\>8h/ wk)
* Usage of any prescribed medication except for oral contraceptives
* Use of systemic antibiotics in the period of 3 month prior to the study
* For women: pregnant or lactating
* For women: not using oral contraceptives
* For women: Unwilling to use oral contraceptives for consecutively for at least the total study duration
* Liver function parameters (ALAT, ASAT, and γ-GT) and renal function parameters (Serum creatinin) outside the normal range

Primary outcomes:
measure: Differences between dietary periods in concentrations of potential biomerkers in blood and urine
timeFrame: On the last day of every one week intervention period
Secondary outcomes:
measure: Differences between dietary period in estimated renal filtration
timeFrame: blood and urine collection on the last day of each intervention period
measure: Differences between dietary periods in urinary acid excretion
timeFrame: urine collection on the last day of each intervention period
Other outcomes:
Locations:
city: Wageningen
country: Netherlands
facility: Wageningen University
state: Gelderland
Study officials:
References:
citation: Vissers LET, Soedamah-Muthu SS, van der Schouw YT, Zuithoff NPA, Geleijnse JM, Sluijs I. Consumption of a diet high in dairy leads to higher 15:0 in cholesteryl esters of healthy people when compared to diets high in meat and grain. Nutr Metab Cardiovasc Dis. 2020 May 7;30(5):804-809. doi: 10.1016/j.numecd.2020.01.006. Epub 2020 Jan 25.