Protein Digestion KineticsPARROTNCT02546141
Postprandial Plasma Amino Acid Concentrations After Dairy Consumption
A study testing skimmed milk (UHT), skimmed milk (pasteurized) and skimmed yoghurt in people with Protein Digestion Kinetics, run by NIZO Food Research at 1 site in Netherlands.
Trial summary
This study was designed to obtain information about the change in postprandial amino acids in blood over time, after consumption of different dairy products, in an elderly population and how this relates to gastric emptying rate and feelings of satiety. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Protein Digestion Kinetics
- What is being tested?
- skimmed milk (UHT), skimmed milk (pasteurized) and skimmed yoghurt
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteNetherlands
- Study dates
- Oct 2015to Dec 2015
- 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age over 60y
- BMI 21-30 kg/m2
- Non-smoking
- Healthy as assessed by the NIZO lifestyle and health questionnaire
- Regular and normal Dutch eating habits as assessed by the NIZO lifestyle and health questionnaire (3 main meals per day)
- Veins suitable for cannulation (blood sampling)
Who cannot join
- Participation in any clinical trial including blood sampling and/or administration of substances up to 30 days before Day 01 of this study
- Having a history of medical or surgical events that may significantly affect the study outcome, including: Inflammatory bowel disease, hepatitis, pancreatitis, ulcers, gastrointestinal or rectal bleeding; major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy, or bowel resection; known or suspected gastrointestinal disorders, colon or GI tract cancer
- Use of the following medication: glucose lowering drugs, insulin; medication that may impact gastric emptying (e.g. gastric acid inhibitors or laxatives)
- Diagnosed with diabetes, being treated for high blood glucose or increased fasting blood glucose (> 7 mmol/l in finger prick blood) as assessed during screening visit
- For men: Hb <8,5 mmol/l as assessed during screening visit; for women: Hb <7,5 mmol/l.
- Use of protein supplements
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- Mental status that is incompatible with the proper conduct of the study
- A self-reported reported food allergy or sensitivity to dairy ingredients
- A self-reported allergy or sensitivity to acetaminophen
- Alcohol consumption > 28 units/week and 4/day
- Reported unexplained weight loss or weight gain of > 3 kg in the month prior to pre-study screening, or intention to lose weight during the study period
- Reported slimming or medically prescribed diet
- Recent blood donation (<1 month prior to Day 01 of the study)
- Not willing or afraid to give up blood donation during the study
- Personnel of NIZO food research or Wageningen University, department of Human Nutrition, their partner and their first and second degree relatives
- Not having a general practitioner
- Not willing to accept information-transfer concerning participation in the study, or information regarding his health, like laboratory results and eventual adverse events to and from his general practitioner
Trial locations and contacts
1 site in 1 country.
About this study
This study was designed to obtain information about the change in postprandial amino acids in blood over time, after consumption of different dairy products, in an elderly population and how this relates to gastric emptying rate and feelings of satiety.
- Conditions
- Protein Digestion Kinetics
- Being tested
- skimmed milk (UHT), skimmed milk (pasteurized), skimmed yoghurt, full-fat milk (UHT), non-homogenized full-fat milk (pasteurized)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
skimmed milk (UHT)Other
skimmed milk (pasteurized)Other
skimmed yoghurtOther
full-fat milk (UHT)Other
non-homogenized full-fat milk (pasteurized)Other
full-fat cheese (semi-matured)Other
whey proteinOther
micellar caseinOther
| Study group | Role | What they receive |
|---|---|---|
| skimmed milk (UHT) | Active comparator | portion size that contains 25 g of protein, oral, single administration Receives: Other: skimmed milk (UHT) |
| skimmed milk (pasteurized) | Active comparator | portion size that contains 25 g of protein, oral, single administration Receives: Other: skimmed milk (pasteurized) |
| skimmed yoghurt | Active comparator | portion size that contains 25 g of protein, oral, single administration Receives: Other: skimmed yoghurt |
| full-fat milk (UHT) | Active comparator | portion size that contains 25 g of protein, oral, single administration Receives: Other: full-fat milk (UHT) |
| non-homogenized full-fat milk (pasteurized) | Active comparator | portion size that contains 25 g of protein, oral, single administration Receives: Other: non-homogenized full-fat milk (pasteurized) |
| full-fat cheese (semi-matured) | Active comparator | portion size that contains 25 g of protein, oral, single administration Receives: Other: full-fat cheese (semi-matured) |
| whey protein | Active comparator | portion size that contains 25 g of protein, oral, single administration Receives: Other: whey protein |
| micellar casein | Active comparator | portion size that contains 25 g of protein, oral, single administration Receives: Other: micellar casein |
What is being measured
The primary outcome is the main question the study is designed to answer.
iAUC for postprandial individual plasma amino acids
Measured: 0-300 min after consumption
Cmax for postprandial individual plasma amino acids
Measured: 0-300 min after consumption
Tmax for postprandial individual plasma amino acids
Measured: 0-300 min after consumption
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2015 (estimated)
- Study startOct 2015
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Protein Digestion KineticsStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- NIZO Food Research
- Sponsor type
- University, hospital or other
- Collaborators
- FrieslandCampina
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02546141
- Sponsor's protocol ID
- NL53912.081.15
- Other IDs
- METC nr 15/18
- Acronym
- PARROT
- Status last verified
- Jan 2016
- First submitted
- 8 Sep 2015
- Last updated
- 12 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postprandial Plasma Amino Acid Concentrations After Dairy Consumption
- ClinicalTrials.gov ID
- NCT02546141
- Acronym / sponsor ID
- PARROT / NL53912.081.15
- Conditions
- Protein Digestion Kinetics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- NIZO Food ResearchUniversity, hospital or other
- Collaborators
- FrieslandCampina
- Study start
- Oct 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 10 Sep 2015 (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.
This study was designed to obtain information about the change in postprandial amino acids in blood over time, after consumption of different dairy products, in an elderly population and how this relates to gastric emptying rate and feelings of satiety.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| skimmed milk (UHT) | Active comparator | Other: skimmed milk (UHT)portion size that contains 25 g of protein, oral, single administration |
| skimmed milk (pasteurized) | Active comparator | Other: skimmed milk (pasteurized)portion size that contains 25 g of protein, oral, single administration |
| skimmed yoghurt | Active comparator | Other: skimmed yoghurtportion size that contains 25 g of protein, oral, single administration |
| full-fat milk (UHT) | Active comparator | Other: full-fat milk (UHT)portion size that contains 25 g of protein, oral, single administration |
| non-homogenized full-fat milk (pasteurized) | Active comparator | Other: non-homogenized full-fat milk (pasteurized)portion size that contains 25 g of protein, oral, single administration |
| full-fat cheese (semi-matured) | Active comparator | Other: full-fat cheese (semi-matured)portion size that contains 25 g of protein, oral, single administration |
| whey protein | Active comparator | Other: whey proteinportion size that contains 25 g of protein, oral, single administration |
| micellar casein | Active comparator | Other: micellar caseinportion size that contains 25 g of protein, oral, single administration |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age over 60y
- BMI 21-30 kg/m2
- Non-smoking
- Healthy as assessed by the NIZO lifestyle and health questionnaire
- Regular and normal Dutch eating habits as assessed by the NIZO lifestyle and health questionnaire (3 main meals per day)
Key exclusion criteria (17 listed)
- Participation in any clinical trial including blood sampling and/or administration of substances up to 30 days before Day 01 of this study
- Having a history of medical or surgical events that may significantly affect the study outcome, including: Inflammatory bowel disease, hepatitis, pancreatitis, ulcers, gastrointestinal or rectal bleeding; major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy, or bowel resection; known or suspected gastrointestinal disorders, colon or GI tract cancer
- Use of the following medication: glucose lowering drugs, insulin; medication that may impact gastric emptying (e.g. gastric acid inhibitors or laxatives)
- Diagnosed with diabetes, being treated for high blood glucose or increased fasting blood glucose (> 7 mmol/l in finger prick blood) as assessed during screening visit
- For men: Hb <8,5 mmol/l as assessed during screening visit; for women: Hb <7,5 mmol/l.
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 |
|---|---|---|
| skimmed milk (UHT) | Other | skimmed milk (UHT) |
| skimmed milk (pasteurized) | Other | skimmed milk (pasteurized) |
| skimmed yoghurt | Other | skimmed yoghurt |
| full-fat milk (UHT) | Other | full-fat milk (UHT) |
| non-homogenized full-fat milk (pasteurized) | Other | non-homogenized full-fat milk (pasteurized) |
| full-fat cheese (semi-matured) | Other | full-fat cheese (semi-matured) |
| whey protein | Other | whey protein |
| micellar casein | Other | micellar casein |
Primary outcome
iAUC for postprandial individual plasma amino acids
Time frame: 0-300 min after consumption
Cmax for postprandial individual plasma amino acids
Time frame: 0-300 min after consumption
Tmax for postprandial individual plasma amino acids
Time frame: 0-300 min after consumption
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 12 Jan 2016.
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 skimmed milk (UHT), skimmed milk (pasteurized) and skimmed yoghurt in people with Protein Digestion Kinetics, run by NIZO Food Research 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 6 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 12 Jan 2016. 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?
iAUC for postprandial individual plasma amino acids (time frame: 0-300 min after consumption). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Jan 2016; AzTrials last refreshed its copy on 6 Nov 2026.