Postprandial Blood Amino Acid Response (PARROT-2)

Postprandial Blood 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 with varying proportions of whey protein and caseins, and different processing conditions.

Study Overview

• Status: Completed
• Conditions: Protein Digestion Kinetics
• Intervention / Treatment: Dietary supplement: Whey protein concentrate; Dietary supplement: Yoghurt; Dietary supplement: 50%whey-50% casein (Standard); Dietary supplement: 50%whey-50% casein (Alternative); Dietary supplement: Micellar Casein Isolate- WPH; Dietary supplement: Micellar Casein Isolate - Na-caseinate; Dietary supplement: Micellar Casein Isolate; Dietary supplement: UHT milk; Dietary supplement: Recombined milk; Dietary supplement: Recombined 50%whey milk; Dietary supplement: Ca-caseinate; Dietary supplement: Milk protein isolate

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Ede, Netherlands
    • NIZO

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

12

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Whey protein concentrate; portion size that contains 25 g of protein, oral, single administration	Dietary supplement: Whey protein concentrate; see arm description
Experimental: Yoghurt; portion size that contains 25 g of protein, oral, single administration	Dietary supplement: Yoghurt; see arm description
Experimental: 50%whey-50% casein (Standard); portion size that contains 25 g of protein, oral, single administration	Dietary supplement: 50%whey-50% casein (Standard); see arm description
Experimental: 50%whey-50% casein (Alternative); portion size that contains 25 g of protein, oral, single administration	Dietary supplement: 50%whey-50% casein (Alternative); see arm description
Experimental: Micellar Casein Isolate- WPH; portion size that contains 25 g of protein, oral, single administration	Dietary supplement: Micellar Casein Isolate- WPH; see arm description
Experimental: Micellar Casein Isolate - Na-caseinate; portion size that contains 25 g of protein, oral, single administration	Dietary supplement: Micellar Casein Isolate - Na-caseinate; see arm description
Experimental: Micellar Casein Isolate; portion size that contains 25 g of protein, oral, single administration	Dietary supplement: Micellar Casein Isolate; see arm description
Experimental: UHT milk; portion size that contains 25 g of protein, oral, single administration	Dietary supplement: UHT milk; see arm description
Experimental: Recombined milk; portion size that contains 25 g of protein, oral, single administration	Dietary supplement: Recombined milk; see arm description
Experimental: Recombined 50% whey milk; portion size that contains 25 g of protein, oral, single administration	Dietary supplement: Recombined 50%whey milk; see arm description
Experimental: Ca-caseinate; portion size that contains 25 g of protein, oral, single administration	Dietary supplement: Ca-caseinate; see arm description
Experimental: Milk protein isolate; portion size that contains 25 g of protein, oral, single administration	Dietary supplement: Milk protein isolate; see arm description

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
iAUC for postprandial individual plasma amino acids	Time Frame: 0-300 min after consumption
Cmax for postprandial individual plasma amino acids	Time Frame: 0-300 min after consumption

Collaborators and Investigators

• Sponsor: NIZO Food Research
• Collaborators: FrieslandCampina

Study record dates

Study Major Dates

• Study Start (Actual): October 25, 2017
• Primary Completion (Actual): March 1, 2018
• Study Completion (Actual): May 2, 2018

Study Registration Dates

• First Submitted: October 13, 2017
• First Submitted That Met QC Criteria: October 13, 2017
• First Posted (Actual): October 18, 2017

Study Record Updates

• Last Update Posted (Actual): September 5, 2018
• Last Update Submitted That Met QC Criteria: September 3, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Chelating Agents; Sequestering Agents; Caseins
• Other Study ID Numbers: NL62458.072.17; NIZO175 (Other Identifier: NIZO)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No