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Completed

NCT Number: NCT01314040

Study to Identify Biomarkers for Protein Intake

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.

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Key information

Conditions

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

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wageningen University

Wageningen, Gelderland, 6700 EV, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Run in diet

Other

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

High meat protein diet

Other

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

High dairy protein diet

Other

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

High grain protein diet

Other

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

Primary outcomes

  1. Differences between dietary periods in concentrations of potential biomerkers in blood and urine

    Time frame: On the last day of every one week intervention period

    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

Secondary outcomes

  1. Differences between dietary period in estimated renal filtration

    Time frame: blood and urine collection on the last day of each intervention period

    Renal filtration will be estimated using bromide distribution in combination with bio-impedance measurement

  2. Differences between dietary periods in urinary acid excretion

    Time frame: urine collection on the last day of each intervention period

Sponsors and collaborators

Lead sponsor

Wageningen University

Other

Collaborators

  • Top Institute Food and Nutrition

Registry information

Official study title

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

Acronym: Biomarker

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Mar 14, 2011
Registry last updated
Jun 1, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.