Biological AvailabilityNCT02966704
Stable Isotope Method to Assess Dietary Protein Quality
A study testing intrinsically labeled milk protein in people with Biological Availability, run by Wageningen University.
Trial summary
The evaluation of protein quality has been identified as the top priority question by the Food and Agricultural Organization (FAO) of the United Nations. However, the current available methods do not precisely estimate protein quality, or need invasive procedures. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Biological Availability
- What is being tested?
- intrinsically labeled milk protein
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- 21 Jul 2016to 21 Nov 2016
- 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy
- Age: 20 - 35 y
- BMI: 18.5 - 25 kg/m2
- Stable dietary habits
- Veins suitable for cannulation (blood sampling)
Who cannot join
- Having a history of medical or surgical events that may significantly affect the study outcome
- Medical drug use accept incidental use of paracetamol
- (Chronic) disease which might influence the study outcomes e.g. diabetes mellitus or any other endocrine disorder, active cardiovascular disease, hepatic disease, renal disease, cancer
- Milk protein intolerance
- Alcohol consumption of >14 (women) or > 21 (men) units per week
- Drug abuse
Show all 17Show fewer
- Moderate intense physical activity (exercise) for more than 5 hours/week
- Reported weight loss or weight gain of > 3 kg in the month prior to pre-study screening
- Reported slimming diet, or medically prescribed diet
- Having a habitual diet with a protein content of <10 En% > 30 En%
- Reported vegan or macrobiotic life-style
- Recent blood donation (<1 month prior to Day 01 of the study)
- Not willing to comply to the controlled dietary intervention guidelines
- Not willing or afraid to give up blood donation during the study
- Personnel of Wageningen University, department of Human Nutrition, their partner and their first and second degree relatives
- Current and within 1 month participation in other research from the Division of Human Nutrition
- Not having a general practitioner
About this study
Official title: A Dual Stable Isotope Method to Assess Dietary Protein Quality in Humans: Characterization of Intrinsically Labelled 15N Milk Protein as a Reference Protein
The evaluation of protein quality has been identified as the top priority question by the Food and Agricultural Organization (FAO) of the United Nations. However, the current available methods do not precisely estimate protein quality, or need invasive procedures. The proposed 'dual tracer approach' is a non-invasive method to evaluate protein quality in humans.
The present project characterizes the use of 15N-intrinsically-labelled milk protein as a reference-protein for development a non-invasive method that can be used to assess protein quality in human subjects
Read the detailed description
Rationale: The evaluation of protein quality has been identified as the top priority question by the Food and Agricultural Organization (FAO) of the United Nations. However, the current available methods do not precisely estimate protein quality, or need invasive procedures. The proposed 'dual tracer approach' is a minimal invasive method to evaluate protein quality in humans.
Objective: The present project characterizes the use of 15N-intrinsically-labelled milk protein as a reference-protein for development a minimal invasive method that can be used to assess protein quality in human subjects. For this purpose, our primary objectives are to define the digestive and metabolic behaviour and distribution of the 15N-intrinsically-labelled milk protein compared to the internal standard 13C-spirulina.
Study design: Randomized cross-over trial with two experimental meals. Study population: Healthy male and female, age 18-35y Intervention (if applicable): On two separate test days, subjects will receive a semi liquid meal (pudding) divided in 9 portions, (meal 1: 27 En% Protein,10 En% fat, 62 En% carbohydrates; meal 2: 14 En% Protein,10 En% fat, 75 En% carbohydrates), with intrinsically labelled 15N protein powder. Furthermore, the meal will contain a trace amount of 13C-labelled algae protein as an internal standard. Meals will differ in the amount (e.g. 50g or 25g) of 15N-labelled milk protein.
Main study parameters/endpoints: The ratio of isotopic enrichment (15N/13C) of (total) amino acids of the test meal and the blood plasma as determined by (gas chromatography-) isotope ratio mass spectrometry ((GC)-IRMS).
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: A meal challenge with intrinsically labelled protein and addition of stable isotope tracer is frequently used in postprandial studies. Stable isotopes are naturally occurring isotopes and are not harmful for subjects, as there is no decay. Furthermore, placing venous catheters and blood sampling can occasionally cause a local haematoma or bruise and some participants may report pain or discomfort. Subjects have to come to the research facility three times, a screening visit of 1 hour, and 2 experimental days of 7 hours. Subjects will be financially compensated for participation.
- Conditions
- Biological Availability
- Being tested
- intrinsically labeled milk protein
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intrinsically labeled milk proteinDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| meal 1 | Experimental | mixed meal with high level of intrinsically labeled milk protein Receives: Dietary Supplement: intrinsically labeled milk protein |
| meal 2 | Experimental | mixed meal with low level of intrinsically labeled milk protein Receives: Dietary Supplement: intrinsically labeled milk protein |
What is being measured
The primary outcome is the main question the study is designed to answer.
ratio of isotopic enrichment
Measured: 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2016 (estimated)
- Study start21 Jul 2016
- Primary completion21 Nov 2016
- Study completion21 Nov 2016
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 Biological AvailabilityStudies 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
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wageningen University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02966704
- Sponsor's protocol ID
- NL56440.081.16
- Status last verified
- Dec 2017
- First submitted
- 8 Jan 2016
- Last updated
- 14 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
van der Wielen N, Khodorova NV, Gerrits WJJ, Gaudichon C, Calvez J, Tome D, Mensink M. Blood 15N:13C Enrichment Ratios Are Proportional to the Ingested Quantity of Protein with the Dual-Tracer Approach for Determining Amino Acid Bioavailability in Humans. J Nutr. 2020 Sep 1;150(9):2346-2352. doi: 10.1093/jn/nxaa205.
PubMed 32710787
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Dual Stable Isotope Method to Assess Dietary Protein Quality in Humans: Characterization of Intrinsically Labelled 15N Milk Protein as a Reference Protein
- ClinicalTrials.gov ID
- NCT02966704
- Acronym / sponsor ID
- NL56440.081.16
- Conditions
- Biological Availability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Wageningen UniversityUniversity, hospital or other
- Study start
- 21 Jul 2016 (actual)
- Primary completion
- 21 Nov 2016 (actual)
- Study completion
- 21 Nov 2016 (actual)
- First posted
- 17 Nov 2016 (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.
The evaluation of protein quality has been identified as the top priority question by the Food and Agricultural Organization (FAO) of the United Nations. However, the current available methods do not precisely estimate protein quality, or need invasive procedures. The proposed 'dual tracer approach' is a non-invasive method to evaluate protein quality in humans.
The present project characterizes the use of 15N-intrinsically-labelled milk protein as a reference-protein for development a non-invasive method that can be used to assess protein quality in human subjects
Detailed description
Rationale: The evaluation of protein quality has been identified as the top priority question by the Food and Agricultural Organization (FAO) of the United Nations. However, the current available methods do not precisely estimate protein quality, or need invasive procedures. The proposed 'dual tracer approach' is a minimal invasive method to evaluate protein quality in humans.
Objective: The present project characterizes the use of 15N-intrinsically-labelled milk protein as a reference-protein for development a minimal invasive method that can be used to assess protein quality in human subjects. For this purpose, our primary objectives are to define the digestive and metabolic behaviour and distribution of the 15N-intrinsically-labelled milk protein compared to the internal standard 13C-spirulina.
Study design: Randomized cross-over trial with two experimental meals. Study population: Healthy male and female, age 18-35y Intervention (if applicable): On two separate test days, subjects will receive a semi liquid meal (pudding) divided in 9 portions, (meal 1: 27 En% Protein,10 En% fat, 62 En% carbohydrates; meal 2: 14 En% Protein,10 En% fat, 75 En% carbohydrates), with intrinsically labelled 15N protein powder. Furthermore, the meal will contain a trace amount of 13C-labelled algae protein as an internal standard. Meals will differ in the amount (e.g. 50g or 25g) of 15N-labelled milk protein.
Main study parameters/endpoints: The ratio of isotopic enrichment (15N/13C) of (total) amino acids of the test meal and the blood plasma as determined by (gas chromatography-) isotope ratio mass spectrometry ((GC)-IRMS).
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: A meal challenge with intrinsically labelled protein and addition of stable isotope tracer is frequently used in postprandial studies. Stable isotopes are naturally occurring isotopes and are not harmful for subjects, as there is no decay. Furthermore, placing venous catheters and blood sampling can occasionally cause a local haematoma or bruise and some participants may report pain or discomfort. Subjects have to come to the research facility three times, a screening visit of 1 hour, and 2 experimental days of 7 hours. Subjects will be financially compensated for participation.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| meal 1 | Experimental | Dietary Supplement: intrinsically labeled milk proteinmixed meal with high level of intrinsically labeled milk protein |
| meal 2 | Experimental | Dietary Supplement: intrinsically labeled milk proteinmixed meal with low level of intrinsically labeled milk protein |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy
- Age: 20 - 35 y
- BMI: 18.5 - 25 kg/m2
- Stable dietary habits
- Veins suitable for cannulation (blood sampling)
Key exclusion criteria (17 listed)
- Having a history of medical or surgical events that may significantly affect the study outcome
- Medical drug use accept incidental use of paracetamol
- (Chronic) disease which might influence the study outcomes e.g. diabetes mellitus or any other endocrine disorder, active cardiovascular disease, hepatic disease, renal disease, cancer
- Milk protein intolerance
- Alcohol consumption of >14 (women) or > 21 (men) units per week
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 |
|---|---|---|
| intrinsically labeled milk protein | Dietary supplement | meal 1, meal 2 |
Primary outcome
ratio of isotopic enrichment
Time frame: 6 hours
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 14 Dec 2017.
- Derived from this study: PubMed 32710787van der Wielen N, Khodorova NV, Gerrits WJJ, Gaudichon C, Calvez J, Tome D, Mensink M. Blood 15N:13C Enrichment Ratios Are Proportional to the Ingested Quantity of Protein with the Dual-Tracer Approach for Determining Amino Acid Bioavailability in Humans. J Nutr. 2020 Sep 1;150(9):2346-2352. doi: 10.1093/jn/nxaa205.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing intrinsically labeled milk protein in people with Biological Availability, run by Wageningen University.
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 5 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 14 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
ratio of isotopic enrichment (time frame: 6 hours). 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 NCT02966704, 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 14 Dec 2017.