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Completed

NCT Number: NCT03547362

Real-time Amino Acid Profiling

This study was designed to obtain information about the effect of new combinations of dairy proteins, in small servings with high protein concentrations, on postprandial amino acid kinetics in blood in an older population.

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Key information

Age range

65 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NIZO Food Research

Ede, Gelderland, 6718ZB, Netherlands

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Age ≥65 and ≤80
  • BMI ≥20 and ≤32 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 1 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 unexpected 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 to give up blood donation during the study
  • Personnel of NIZO food research and FrieslandCampina, 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 or her health, like laboratory results and eventual adverse events to and from his general practitioner

Treatment and study plan

Casein

Dietary Supplement

See arm description

Dairy protein blend 1

Dietary Supplement

See arm description

Whey Protein

Dietary Supplement

See arm description

Dairy protein blend 2

Dietary Supplement

See arm description

Dairy protein blend 3

Dietary Supplement

See arm description

Dairy protein blend 4

Dietary Supplement

See arm description

Primary outcomes

  1. Postprandial serum amino acid concentration

    Time frame: 0-300 min after consumption

    Blood amino acid concentrations (mmol/L) before and at 13 time points (up till 5 hours) after consumption of the dairy products.

Sponsors and collaborators

Lead sponsor

NIZO Food Research

Other

Collaborators

  • FrieslandCampina

Registry information

Acronym: RAP

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jun 6, 2018
Registry last updated
Jul 11, 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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