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OpenTrials
Completed

NCT Number: NCT02546141

Postprandial Plasma 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, in an elderly population and how this relates to gastric emptying rate and feelings of satiety.

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Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NIZO food research

Ede, Netherlands

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 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)

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
  • 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

Treatment and study plan

skimmed milk (UHT)

Other

skimmed milk (pasteurized)

Other

skimmed yoghurt

Other

full-fat milk (UHT)

Other

non-homogenized full-fat milk (pasteurized)

Other

full-fat cheese (semi-matured)

Other

Whey Protein

Other

micellar casein

Other

Primary outcomes

  1. iAUC for postprandial individual plasma amino acids

    Time frame: 0-300 min after consumption

  2. Cmax for postprandial individual plasma amino acids

    Time frame: 0-300 min after consumption

  3. Tmax for postprandial individual plasma amino acids

    Time frame: 0-300 min after consumption

Sponsors and collaborators

Lead sponsor

NIZO Food Research

Other

Collaborators

  • FrieslandCampina

Registry information

Acronym: PARROT

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Sep 10, 2015
Registry last updated
Jan 12, 2016

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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