Study to Identify Biomarkers for Protein Intake (Biomarker)

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.

Study Overview

• Status: Completed
• Conditions: Identify New Biomarkers in Blood or Urine After Consumption of Meat Protein, Dairy Protein and Grain Protein in Healthy Subjects.
• Intervention / Treatment: Other: Run in diet; Other: High meat protein diet; Other: High dairy protein diet; Other: High grain protein diet

• Study Type: Interventional
• Enrollment (Anticipated): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Gelderland
    • Wageningen, Gelderland, Netherlands, 6700 EV
      • Wageningen University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Wageningen University
• Collaborators: Top Institute Food and Nutrition

Publications and helpful links

General Publications

• Vissers LET, Soedamah-Muthu SS, van der Schouw YT, Zuithoff NPA, Geleijnse JM, Sluijs I. Consumption of a diet high in dairy leads to higher 15:0 in cholesteryl esters of healthy people when compared to diets high in meat and grain. Nutr Metab Cardiovasc Dis. 2020 May 7;30(5):804-809. doi: 10.1016/j.numecd.2020.01.006. Epub 2020 Jan 25.

Study record dates

Study Major Dates

• Study Start: March 1, 2011
• Primary Completion (Actual): April 1, 2011
• Study Completion (Actual): April 1, 2011

Study Registration Dates

• First Submitted: February 25, 2011
• First Submitted That Met QC Criteria: March 10, 2011
• First Posted (Estimate): March 14, 2011

Study Record Updates

• Last Update Posted (Estimate): June 1, 2011
• Last Update Submitted That Met QC Criteria: May 30, 2011
• Last Verified: May 1, 2011

More Information

Terms related to this study

• Keywords: Biomarkers; Dietary protein; filtration rate; urinary acid excretion
• Other Study ID Numbers: A1003/ WP-B1