Identify New Biomarkers in Blood or Urine After Consumption of Meat Protein, Dairy Protein and Grain Protein in Healthy Subjects.BiomarkerNCT01314040
Study to Identify Biomarkers for Protein Intake
A study testing Run in diet, High meat protein diet and High dairy protein diet in people with Identify New Biomarkers in Blood or Urine After Consumption of Meat Protein, Dairy Protein and Grain Protein in Healthy Subjects., run by Wageningen University at 1 site in Netherlands.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Identify New Biomarkers in Blood or Urine After Consumption of Meat Protein, Dairy Protein and Grain Protein in Healthy Subjects.
- What is being tested?
- Run in diet, High meat protein diet and High dairy protein diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteNetherlands
- Study dates
- Mar 2011to Apr 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 18-40 years
- BMI between 18.5 and 30 kg/m2
- Healthy (As judged by the participant)
- Written informed consent obtained
Who cannot join
- 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
Show all 17Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Being tested
- Run in diet, High meat protein diet, High dairy protein diet, High grain protein diet
- Keywords
- Dietary protein, Biomarkers, filtration rate, urinary acid excretion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Run in dietOther
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 dietOther
Fully controlled diet during 7 days. Participants will consume 18 en% protein, mainly from meat.
High dairy protein dietOther
Fully controlled dietary intervention during 7 days. Participants will consume 20 en% protein. Mainly from dairy
High grain protein dietOther
Fully controlled dietary intervention for 7 days. Participants will consume 20 en% of protein. Mainly from grain
| Study group | Role | What they receive |
|---|---|---|
| Run in | Other | Not described Receives: Other: Run in diet |
| High meat protein diet | Experimental | Not described Receives: Other: High meat protein diet |
| High dairy protein diet | Experimental | Not described Receives: Other: High dairy protein diet |
| High grain protein diet | Experimental | Not described Receives: Other: High grain protein diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: On the last day of every one week intervention period
Secondary outcomes (2)
Differences between dietary period in estimated renal filtration
Renal filtration will be estimated using bromide distribution in combination with bio-impedance measurement
Measured: blood and urine collection on the last day of each intervention period
Differences between dietary periods in urinary acid excretion
Measured: urine collection on the last day of each intervention period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2011 (estimated)
- Study startMar 2011
- Primary completionApr 2011
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Identify New Biomarkers in Blood or Urine After Consumption of Meat Protein, Dairy Protein and Grain Protein in Healthy Subjects.Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wageningen University
- Sponsor type
- University, hospital or other
- Collaborators
- Top Institute Food and Nutrition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01314040
- Sponsor's protocol ID
- A1003/ WP-B1
- Acronym
- Biomarker
- Status last verified
- May 2011
- First submitted
- 25 Feb 2011
- Last updated
- 1 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 32139254
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study to Identify Biomarkers for Protein Intake; a Randomized, Fully Controlled Feeding Study
- ClinicalTrials.gov ID
- NCT01314040
- Acronym / sponsor ID
- Biomarker / A1003/ WP-B1
- Keywords
- Dietary protein, Biomarkers, filtration rate, urinary acid excretion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Wageningen UniversityUniversity, hospital or other
- Collaborators
- Top Institute Food and Nutrition
- Study start
- Mar 2011
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 14 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Run in | Other | Other: Run in diet |
| High meat protein diet | Experimental | Other: High meat protein diet |
| High dairy protein diet | Experimental | Other: High dairy protein diet |
| High grain protein diet | Experimental | Other: High grain protein diet |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age 18-40 years
- BMI between 18.5 and 30 kg/m2
- Healthy (As judged by the participant)
- Written informed consent obtained
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Run in dietFully 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 | Run in |
| High meat protein dietFully controlled diet during 7 days. Participants will consume 18 en% protein, mainly from meat. | Other | High meat protein diet |
| High dairy protein dietFully controlled dietary intervention during 7 days. Participants will consume 20 en% protein. Mainly from dairy | Other | High dairy protein diet |
| High grain protein dietFully controlled dietary intervention for 7 days. Participants will consume 20 en% of protein. Mainly from grain | Other | High grain protein diet |
Primary outcome
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
2 secondary outcomes
Differences between dietary period in estimated renal filtration
Time frame: blood and urine collection on the last day of each intervention period
Differences between dietary periods in urinary acid excretion
Time frame: urine collection on the last day of each intervention period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2011.
- Derived from this study: PubMed 32139254Vissers 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Run in diet, High meat protein diet and High dairy protein diet in people with Identify New Biomarkers in Blood or Urine After Consumption of Meat Protein, Dairy Protein and Grain Protein in Healthy Subjects., run by Wageningen University at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01314040, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2011.