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

February 25, 2011
May 30, 2011
March 2011
April 2011   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01314040 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Study to Identify Biomarkers for Protein Intake
Study to Identify Biomarkers for Protein Intake; a Randomized, Fully Controlled Feeding Study

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Identify New Biomarkers in Blood or Urine After Consumption of Meat Protein, Dairy Protein and Grain Protein in Healthy Subjects.
  • 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
  • Other: High meat protein diet
    Fully controlled diet during 7 days. Participants will consume 18 en% protein, mainly from meat.
  • Other: High dairy protein diet
    Fully controlled dietary intervention during 7 days. Participants will consume 20 en% protein. Mainly from dairy
  • Other: High grain protein diet
    Fully controlled dietary intervention for 7 days. Participants will consume 20 en% of protein. Mainly from grain
  • Run in
    Intervention: Other: Run in diet
  • Experimental: High meat protein diet
    Intervention: Other: High meat protein diet
  • Experimental: High dairy protein diet
    Intervention: Other: High dairy protein diet
  • Experimental: High grain protein diet
    Intervention: Other: High grain protein diet
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
25
April 2011
April 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 40 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT01314040
A1003/ WP-B1
No
J.M. Geleijnse PhD, Wageningen University
Wageningen University
Top Institute Food and Nutrition
Not Provided
Wageningen University
May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP