Protein Digestion KineticsPARROT-2NCT03313791
Postprandial Blood Amino Acid Response
A study testing Whey protein concentrate, Yoghurt and 50%whey-50% casein (Standard) 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 with varying proportions of whey protein and caseins, and different processing conditions. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Protein Digestion Kinetics
- What is being tested?
- Whey protein concentrate, Yoghurt and 50%whey-50% casein (Standard)
- 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
- 25 Oct 2017to 2 May 2018
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18-65y
- BMI 18.5-30 kg/m2
- Non-smoking
- Healthy as assessed by the NIZO lifestyle and health questionnaire ("Verklaring leefgewoonten en gezondheid") and according to the judgment of the study physician.".
- 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)
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- Voluntary participation
- Having given written informed consent
- Willing to comply with study procedures
- Accept use of all encoded data, including publication, and the confidential use and storage of all data for 15 years.
- Accept disclosure of the financial benefit of participation in the study to the authorities concerned
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
- Alcohol consumption for men > 28 units/week and >4/day; for women: >21 units/week and >3/day
- Reported 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, FrieslandCampina 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/her health, like laboratory results and eventual adverse events to and from his general practitioner
- Self reported pregnancy or breastfeeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Postprandial Blood Amino Acid Concentrations After Dairy Consumption
This study was designed to obtain information about the change in postprandial amino acids in blood over time, after consumption of different dairy products with varying proportions of whey protein and caseins, and different processing conditions.
- Conditions
- Protein Digestion Kinetics
- Being tested
- Whey protein concentrate, Yoghurt, 50%whey-50% casein (Standard), 50%whey-50% casein (Alternative), Micellar Casein Isolate- WPH
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whey protein concentrateDietary supplement
see arm description
YoghurtDietary supplement
see arm description
50%whey-50% casein (Standard)Dietary supplement
see arm description
50%whey-50% casein (Alternative)Dietary supplement
see arm description
Micellar Casein Isolate- WPHDietary supplement
see arm description
Micellar Casein Isolate - Na-caseinateDietary supplement
see arm description
Micellar Casein IsolateDietary supplement
see arm description
UHT milkDietary supplement
see arm description
Recombined milkDietary supplement
see arm description
Recombined 50%whey milkDietary supplement
see arm description
Ca-caseinateDietary supplement
see arm description
Milk protein isolateDietary supplement
see arm description
| Study group | Role | What they receive |
|---|---|---|
| Whey protein concentrate | Experimental | portion size that contains 25 g of protein, oral, single administration Receives: Dietary Supplement: Whey protein concentrate |
| Yoghurt | Experimental | portion size that contains 25 g of protein, oral, single administration Receives: Dietary Supplement: Yoghurt |
| 50%whey-50% casein (Standard) | Experimental | portion size that contains 25 g of protein, oral, single administration Receives: Dietary Supplement: 50%whey-50% casein (Standard) |
| 50%whey-50% casein (Alternative) | Experimental | portion size that contains 25 g of protein, oral, single administration Receives: Dietary Supplement: 50%whey-50% casein (Alternative) |
| Micellar Casein Isolate- WPH | Experimental | portion size that contains 25 g of protein, oral, single administration Receives: Dietary Supplement: Micellar Casein Isolate- WPH |
| Micellar Casein Isolate - Na-caseinate | Experimental | portion size that contains 25 g of protein, oral, single administration Receives: Dietary Supplement: Micellar Casein Isolate - Na-caseinate |
| Micellar Casein Isolate | Experimental | portion size that contains 25 g of protein, oral, single administration Receives: Dietary Supplement: Micellar Casein Isolate |
| UHT milk | Experimental | portion size that contains 25 g of protein, oral, single administration Receives: Dietary Supplement: UHT milk |
| Recombined milk | Experimental | portion size that contains 25 g of protein, oral, single administration Receives: Dietary Supplement: Recombined milk |
| Recombined 50% whey milk | Experimental | portion size that contains 25 g of protein, oral, single administration Receives: Dietary Supplement: Recombined 50%whey milk |
| Ca-caseinate | Experimental | portion size that contains 25 g of protein, oral, single administration Receives: Dietary Supplement: Ca-caseinate |
| Milk protein isolate | Experimental | portion size that contains 25 g of protein, oral, single administration Receives: Dietary Supplement: Milk protein isolate |
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: Time Frame: 0-300 min after consumption
Cmax for postprandial individual plasma amino acids
Measured: Time Frame: 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 posted18 Oct 2017
- Study start25 Oct 2017
- Primary completion1 Mar 2018
- Study completion2 May 2018
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
- Model description
- 2 groups of 10 subjects both receive a different set of 6 different dairy products. Each subject within a group will receive all treatments on the same day of the week with a 1 week washout period between treatments. Results of the two groups will be analyzed separately, and products will only be compared within the same group of subjects, treating the data as two independent studies.
- Masking
- Double blind
- Who is masked
- Investigator, 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
- Investigators
- Alwine Kardinaal, PhD, Principal investigator, NIZO Food Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03313791
- Sponsor's protocol ID
- NL62458.072.17
- Other IDs
- NIZO175
- Acronym
- PARROT-2
- Status last verified
- Sep 2018
- First submitted
- 13 Oct 2017
- Last updated
- 5 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postprandial Blood Amino Acid Concentrations After Dairy Consumption
- ClinicalTrials.gov ID
- NCT03313791
- Acronym / sponsor ID
- PARROT-2 / NL62458.072.17
- 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
- 25 Oct 2017 (actual)
- Primary completion
- 1 Mar 2018 (actual)
- Study completion
- 2 May 2018 (actual)
- First posted
- 18 Oct 2017 (actual)
- 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 with varying proportions of whey protein and caseins, and different processing conditions.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 12
- Model description
- 2 groups of 10 subjects both receive a different set of 6 different dairy products. Each subject within a group will receive all treatments on the same day of the week with a 1 week washout period between treatments. Results of the two groups will be analyzed separately, and products will only be compared within the same group of subjects, treating the data as two independent studies.
| Arm | Type | Receives |
|---|---|---|
| Whey protein concentrate | Experimental | Dietary Supplement: Whey protein concentrateportion size that contains 25 g of protein, oral, single administration |
| Yoghurt | Experimental | Dietary Supplement: Yoghurtportion size that contains 25 g of protein, oral, single administration |
| 50%whey-50% casein (Standard) | Experimental | Dietary Supplement: 50%whey-50% casein (Standard)portion size that contains 25 g of protein, oral, single administration |
| 50%whey-50% casein (Alternative) | Experimental | Dietary Supplement: 50%whey-50% casein (Alternative)portion size that contains 25 g of protein, oral, single administration |
| Micellar Casein Isolate- WPH | Experimental | Dietary Supplement: Micellar Casein Isolate- WPHportion size that contains 25 g of protein, oral, single administration |
| Micellar Casein Isolate - Na-caseinate | Experimental | Dietary Supplement: Micellar Casein Isolate - Na-caseinateportion size that contains 25 g of protein, oral, single administration |
| Micellar Casein Isolate | Experimental | Dietary Supplement: Micellar Casein Isolateportion size that contains 25 g of protein, oral, single administration |
| UHT milk | Experimental | Dietary Supplement: UHT milkportion size that contains 25 g of protein, oral, single administration |
| Recombined milk | Experimental | Dietary Supplement: Recombined milkportion size that contains 25 g of protein, oral, single administration |
| Recombined 50% whey milk | Experimental | Dietary Supplement: Recombined 50%whey milkportion size that contains 25 g of protein, oral, single administration |
| Ca-caseinate | Experimental | Dietary Supplement: Ca-caseinateportion size that contains 25 g of protein, oral, single administration |
| Milk protein isolate | Experimental | Dietary Supplement: Milk protein isolateportion size that contains 25 g of protein, oral, single administration |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age 18-65y
- BMI 18.5-30 kg/m2
- Non-smoking
- Healthy as assessed by the NIZO lifestyle and health questionnaire ("Verklaring leefgewoonten en gezondheid") and according to the judgment of the study physician.".
- 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 |
|---|---|---|
| Whey protein concentratesee arm description | Dietary supplement | Whey protein concentrate |
| Yoghurtsee arm description | Dietary supplement | Yoghurt |
| 50%whey-50% casein (Standard)see arm description | Dietary supplement | 50%whey-50% casein (Standard) |
| 50%whey-50% casein (Alternative)see arm description | Dietary supplement | 50%whey-50% casein (Alternative) |
| Micellar Casein Isolate- WPHsee arm description | Dietary supplement | Micellar Casein Isolate- WPH |
| Micellar Casein Isolate - Na-caseinatesee arm description | Dietary supplement | Micellar Casein Isolate - Na-caseinate |
| Micellar Casein Isolatesee arm description | Dietary supplement | Micellar Casein Isolate |
| UHT milksee arm description | Dietary supplement | UHT milk |
| Recombined milksee arm description | Dietary supplement | Recombined milk |
| Recombined 50%whey milksee arm description | Dietary supplement | Recombined 50% whey milk |
| Ca-caseinatesee arm description | Dietary supplement | Ca-caseinate |
| Milk protein isolatesee arm description | Dietary supplement | Milk protein isolate |
Primary outcome
iAUC for postprandial individual plasma amino acids
Time frame: Time Frame: 0-300 min after consumption
Cmax for postprandial individual plasma amino acids
Time frame: 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 5 Sep 2018.
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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.
Alwine Kardinaal, PhD principal investigator
NIZO Food Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Whey protein concentrate, Yoghurt and 50%whey-50% casein (Standard) 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 11 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 5 Sep 2018. 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: Time Frame: 0-300 min after consumption). The study lists 2 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 5 Sep 2018.