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Study to Identify Biomarkers for Protein Intake

Study to Identify Biomarkers for Protein Intake; a Randomized, Fully Controlled Feeding Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01314040
Acronym
Biomarker
Enrollment
25
Registered
2011-03-14
Start date
2011-03-31
Completion date
2011-04-30
Last updated
2011-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

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.

Interventions

OTHERRun in diet

Fully controlled dietary period during 9 days. Participants will receive approximately 15 en% of protein. The amount of protein intake from dairy, meat, and grain will be equal to each other

OTHERHigh meat protein diet

Fully controlled diet during 7 days. Participants will consume 18 en% protein, mainly from meat.

OTHERHigh dairy protein diet

Fully controlled dietary intervention during 7 days. Participants will consume 20 en% protein. Mainly from dairy

OTHERHigh grain protein diet

Fully controlled dietary intervention for 7 days. Participants will consume 20 en% of protein. Mainly from grain

Sponsors

Top Institute Food and Nutrition
CollaboratorOTHER
Wageningen University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Differences between dietary periods in concentrations of potential biomerkers in blood and urineOn the last day of every one week intervention periodPotential biomarkers that will be measured are urinary creatinin, sulphate, carnosine, 1-MH, 3-MH, taurine,14N/15N and creatin in blood. Furthermore, amino acid profiling will be done in blood and urine to detect differences between dietary periods

Secondary

MeasureTime frameDescription
Differences between dietary period in estimated renal filtrationblood and urine collection on the last day of each intervention periodRenal filtration will be estimated using bromide distribution in combination with bio-impedance measurement
Differences between dietary periods in urinary acid excretionurine collection on the last day of each intervention period

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 28, 2026