Study to Identify Biomarkers for Protein Intake

Study Overview
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Brief Summary
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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.

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

Conditions
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Identify New Biomarkers in Blood or Urine After Consumption of Meat Protein, Dairy Protein and Grain Protein in Healthy Subjects.

Intervention / Treatment
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* Other: Run in diet
* Other: High meat protein diet
* Other: High dairy protein diet
* Other: High grain protein diet


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Run in<br> | Other: Run in diet<br>* 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<br>|
| Experimental: High meat protein diet<br> | Other: High meat protein diet<br>* Fully controlled diet during 7 days. Participants will consume 18 en% protein, mainly from meat.<br>|
| Experimental: High dairy protein diet<br> | Other: High dairy protein diet<br>* Fully controlled dietary intervention during 7 days. Participants will consume 20 en% protein. Mainly from dairy<br>|
| Experimental: High grain protein diet<br> | Other: High grain protein diet<br>* Fully controlled dietary intervention for 7 days. Participants will consume 20 en% of protein. Mainly from grain<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Differences between dietary periods in concentrations of potential biomerkers in blood and urine | Potential 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 | On the last day of every one week intervention period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Differences between dietary period in estimated renal filtration | Renal filtration will be estimated using bromide distribution in combination with bio-impedance measurement | blood and urine collection on the last day of each intervention period | 
| Differences between dietary periods in urinary acid excretion |  | urine collection on the last day of each intervention period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dietary protein, Biomarkers, filtration rate, urinary acid excretion