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Study to Identify Biomarkers for Protein Intake

This study has been completed.
Sponsor:
Collaborator:
Top Institute Food and Nutrition
Information provided by:
Wageningen University
ClinicalTrials.gov Identifier:
NCT01314040
First received: February 25, 2011
Last updated: May 30, 2011
Last verified: May 2011
History of Changes
  Purpose

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.


Condition Intervention
Identify New Biomarkers in Blood or Urine After Consumption of Meat Protein, Dairy Protein and Grain Protein in Healthy Subjects.
 Other: Run in diet
Other: High meat protein diet
Other: High dairy protein diet
Other: High grain protein diet

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: Study to Identify Biomarkers for Protein Intake; a Randomized, Fully Controlled Feeding Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Wageningen University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Differences between dietary period in estimated renal filtration [ Time Frame: blood and urine collection on the last day of each intervention period ] [ Designated as safety issue: No ]
    Renal filtration will be estimated using bromide distribution in combination with bio-impedance measurement

  • Differences between dietary periods in urinary acid excretion [ Time Frame: urine collection on the last day of each intervention period ] [ Designated as safety issue: No ]

Estimated Enrollment: 25
Study Start Date: March 2011
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Run in Other: Run 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
Experimental: High meat protein diet Other: High meat protein diet
Fully controlled diet during 7 days. Participants will consume 18 en% protein, mainly from meat.
Experimental: High dairy protein diet Other: High dairy protein diet
Fully controlled dietary intervention during 7 days. Participants will consume 20 en% protein. Mainly from dairy
Experimental: High grain protein diet Other: High grain protein diet
Fully controlled dietary intervention for 7 days. Participants will consume 20 en% of protein. Mainly from grain

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01314040

Locations
Netherlands
Wageningen University
Wageningen, Gelderland, Netherlands, 6700 EV
Sponsors and Collaborators
Wageningen University
Top Institute Food and Nutrition
  More Information

No publications provided

Responsible Party: J.M. Geleijnse PhD, Wageningen University
ClinicalTrials.gov Identifier: NCT01314040     History of Changes
Other Study ID Numbers: A1003/ WP-B1
Study First Received: February 25, 2011
Last Updated: May 30, 2011
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by Wageningen University:
Dietary protein
Biomarkers
filtration rate
urinary acid excretion

ClinicalTrials.gov processed this record on May 19, 2013