ClinicalTrials.gg
CompletedNCT03313791PARROT-2Updated Sep 5, 2018

Postprandial Blood Amino Acid Response

An interventional study of Whey protein concentrate and Yoghurt in Protein Digestion Kinetics, sponsored by NIZO Food Research. Completed at 1 site in Netherlands. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-09-05.

Sponsored by NIZO Food Research · Not applicable, Interventional, and Basic science

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Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Protein Digestion Kinetics
03

In context

Lead sponsor

NIZO Food Research is the lead sponsor of 19 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age 18-65y
  • 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)
  • Voluntary participation
  • Having given written
  • 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

Exclusion criteria

Exclusion Criteria:

  • 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: \<8,5 mmol/l as assessed during screening visit; for women: Hb \<7,5 mmol/l.
  • Use of protein supplements
  • 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
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
10 participants (actual)

Study arms

  • Experimental
    Whey protein concentrate

    portion size that contains 25 g of protein, oral, single administration

    Dietary Supplement: Whey protein concentrate

  • Experimental
    Yoghurt

    portion size that contains 25 g of protein, oral, single administration

    Dietary Supplement: Yoghurt

  • Experimental
    50%whey-50% casein (Standard)

    portion size that contains 25 g of protein, oral, single administration

    Dietary Supplement: 50%whey-50% casein (Standard)

  • Experimental
    50%whey-50% casein (Alternative)

    portion size that contains 25 g of protein, oral, single administration

    Dietary Supplement: 50%whey-50% casein (Alternative)

  • Experimental
    Micellar Casein Isolate- WPH

    portion size that contains 25 g of protein, oral, single administration

    Dietary Supplement: Micellar Casein Isolate- WPH

  • Experimental
    Micellar Casein Isolate - Na-caseinate

    portion size that contains 25 g of protein, oral, single administration

    Dietary Supplement: Micellar Casein Isolate - Na-caseinate

  • Experimental
    Micellar Casein Isolate

    portion size that contains 25 g of protein, oral, single administration

    Dietary Supplement: Micellar Casein Isolate

  • Experimental
    UHT milk

    portion size that contains 25 g of protein, oral, single administration

    Dietary Supplement: UHT milk

  • Experimental
    Recombined milk

    portion size that contains 25 g of protein, oral, single administration

    Dietary Supplement: Recombined milk

  • Experimental
    Recombined 50% whey milk

    portion size that contains 25 g of protein, oral, single administration

    Dietary Supplement: Recombined 50%whey milk

  • Experimental
    Ca-caseinate

    portion size that contains 25 g of protein, oral, single administration

    Dietary Supplement: Ca-caseinate

  • Experimental
    Milk protein isolate

    portion size that contains 25 g of protein, oral, single administration

    Dietary Supplement: Milk protein isolate

Interventions

  • Dietary supplementWhey protein concentrate

    see arm description

  • Dietary supplementYoghurt

    see arm description

  • Dietary supplement50%whey-50% casein (Standard)

    see arm description

  • Dietary supplement50%whey-50% casein (Alternative)

    see arm description

  • Dietary supplementMicellar Casein Isolate- WPH

    see arm description

  • Dietary supplementMicellar Casein Isolate - Na-caseinate

    see arm description

  • Dietary supplementMicellar Casein Isolate

    see arm description

  • Dietary supplementUHT milk

    see arm description

  • Dietary supplementRecombined milk

    see arm description

  • Dietary supplementRecombined 50%whey milk

    see arm description

  • Dietary supplementCa-caseinate

    see arm description

  • Dietary supplementMilk protein isolate

    see arm description

06

What researchers measure

Primary outcomes

  1. iAUC for postprandial individual plasma amino acids

    Time frame: Time Frame: 0-300 min after consumption

  2. Cmax for postprandial individual plasma amino acids

    Time frame: Time Frame: 0-300 min after consumption

07

Study locations

1 site
  • NIZO
    Ede, Netherlands
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Oct 2017 to primary completion in Mar 2018, 4 months.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 13, 2017
First posted
Oct 18, 2017
StartActual
Oct 25, 2017
Primary completionActual
Mar 1, 2018
CompletionActual
May 2, 2018
Last update
Sep 5, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 5, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03313791
Lead sponsor
NIZO Food Research
Collaborators
FrieslandCampina
Responsible party
Sponsor
First posted
Oct 18, 2017
Start date
Oct 25, 2017
Primary completion
Mar 1, 2018
Completion
May 2, 2018
Last update
Sep 5, 2018

Study contacts

Alwine Kardinaal, PhD
principal investigator · NIZO Food Research

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2018. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Whey Proteins

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