Postprandial Blood Amino Acid Response

Protein Digestion Kinetics Clinical Trial

— PARROT-2  

Official title:

Postprandial Blood Amino Acid Concentrations After Dairy Consumption

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03313791
• Other study ID #: NL62458.072.17
• Secondary ID: NIZO175
• Status: Completed
• Phase: N/A
• Start date: October 25, 2017
• Est. completion date: May 2, 2018

Study information

• Verified date: September 2018
• Source: NIZO Food Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: May 2, 2018
• Est. primary completion date: March 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Protein Digestion Kinetics

Intervention

Dietary Supplement:
• Whey protein concentrate
see arm description
• Yoghurt
see arm description
• 50%whey-50% casein (Standard)
see arm description
• 50%whey-50% casein (Alternative)
see arm description
• Micellar Casein Isolate- WPH
see arm description
• Micellar Casein Isolate - Na-caseinate
see arm description
• Micellar Casein Isolate
see arm description
• UHT milk
see arm description
• Recombined milk
see arm description
• Recombined 50%whey milk
see arm description
• Ca-caseinate
see arm description
• Milk protein isolate
see arm description

Locations

Country	Name	City	State
Netherlands	NIZO	Ede

Sponsors (2)

Lead Sponsor	Collaborator
NIZO Food Research	FrieslandCampina

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	iAUC for postprandial individual plasma amino acids		Time Frame: 0-300 min after consumption
Primary	Cmax for postprandial individual plasma amino acids		Time Frame: 0-300 min after consumption