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Completed

NCT Number: NCT03313791

Postprandial Blood Amino Acid Response

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NIZO

Ede, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)
  • 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

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: Hb <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

Treatment and study plan

Whey Protein Concentrate

Dietary Supplement

see arm description

Yoghurt

Dietary 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- WPH

Dietary Supplement

see arm description

Micellar Casein Isolate - Na-caseinate

Dietary Supplement

see arm description

Micellar Casein Isolate

Dietary Supplement

see arm description

UHT milk

Dietary Supplement

see arm description

Recombined milk

Dietary Supplement

see arm description

Recombined 50%whey milk

Dietary Supplement

see arm description

Ca-caseinate

Dietary Supplement

see arm description

Milk protein isolate

Dietary Supplement

see arm description

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

Sponsors and collaborators

Lead sponsor

NIZO Food Research

Other

Collaborators

  • FrieslandCampina

Registry information

Official study title

Postprandial Blood Amino Acid Concentrations After Dairy Consumption

Acronym: PARROT-2

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Oct 18, 2017
Registry last updated
Sep 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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