Postprandial Blood Amino Acid Response

Not Applicable

Completed

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

• Registration Number: NCT03313791
• Lead Sponsor: NIZO Food Research

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-10-13
• Study First Submitted QC: 2017-10-13
• Study First Posted: 2017-10-18
• Study Start: 2017-10-25
• Primary Completion: 2018-03-01
• Study Completion: 2018-05-02
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-03
• Last Update Posted: 2018-09-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Recombined milk	Recombined milk	portion size that contains 25 g of protein, oral, single administration
50%whey-50% casein (Alternative)	50%whey-50% casein (Alternative)	portion size that contains 25 g of protein, oral, single administration
Whey protein concentrate	Whey protein concentrate	portion size that contains 25 g of protein, oral, single administration
Milk protein isolate	Milk protein isolate	portion size that contains 25 g of protein, oral, single administration
Yoghurt	Yoghurt	portion size that contains 25 g of protein, oral, single administration
Micellar Casein Isolate- WPH	Micellar Casein Isolate- WPH	portion size that contains 25 g of protein, oral, single administration
UHT milk	UHT milk	portion size that contains 25 g of protein, oral, single administration
Recombined 50% whey milk	Recombined 50%whey milk	portion size that contains 25 g of protein, oral, single administration
50%whey-50% casein (Standard)	50%whey-50% casein (Standard)	portion size that contains 25 g of protein, oral, single administration
Micellar Casein Isolate - Na-caseinate	Micellar Casein Isolate - Na-caseinate	portion size that contains 25 g of protein, oral, single administration
Ca-caseinate	Ca-caseinate	portion size that contains 25 g of protein, oral, single administration
Micellar Casein Isolate	Micellar Casein Isolate	portion size that contains 25 g of protein, oral, single administration

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

NIZO; 🇳🇱 Ede, Netherlands