Postprandial Blood Amino Acid Response

NCT03313791 | Completed

• 2 other identifiers: NL62458.072.17NIZO175
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Protein Digestion Kinetics

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (12)

Whey protein concentrate

EXPERIMENTAL

portion size that contains 25 g of protein, oral, single administration

Dietary Supplement: Whey protein concentrate

Yoghurt

EXPERIMENTAL

portion size that contains 25 g of protein, oral, single administration

Dietary Supplement: Yoghurt

50%whey-50% casein (Standard)

EXPERIMENTAL

portion size that contains 25 g of protein, oral, single administration

Dietary Supplement: 50%whey-50% casein (Standard)

50%whey-50% casein (Alternative)

EXPERIMENTAL

portion size that contains 25 g of protein, oral, single administration

Dietary Supplement: 50%whey-50% casein (Alternative)

Micellar Casein Isolate- WPH

EXPERIMENTAL

portion size that contains 25 g of protein, oral, single administration

Dietary Supplement: Micellar Casein Isolate- WPH

Micellar Casein Isolate - Na-caseinate

EXPERIMENTAL

portion size that contains 25 g of protein, oral, single administration

Dietary Supplement: Micellar Casein Isolate - Na-caseinate

Micellar Casein Isolate

EXPERIMENTAL

portion size that contains 25 g of protein, oral, single administration

Dietary Supplement: Micellar Casein Isolate

UHT milk

EXPERIMENTAL

portion size that contains 25 g of protein, oral, single administration

Dietary Supplement: UHT milk

Recombined milk

EXPERIMENTAL

portion size that contains 25 g of protein, oral, single administration

Dietary Supplement: Recombined milk

Recombined 50% whey milk

EXPERIMENTAL

portion size that contains 25 g of protein, oral, single administration

Dietary Supplement: Recombined 50%whey milk

Ca-caseinate

EXPERIMENTAL

portion size that contains 25 g of protein, oral, single administration

Dietary Supplement: Ca-caseinate

Milk protein isolate

EXPERIMENTAL

portion size that contains 25 g of protein, oral, single administration

Dietary Supplement: Milk protein isolate

Interventions

Whey protein concentrate DIETARY_SUPPLEMENT

see arm description

Whey protein concentrate

Yoghurt DIETARY_SUPPLEMENT

see arm description

Yoghurt

50%whey-50% casein (Standard) DIETARY_SUPPLEMENT

see arm description

50%whey-50% casein (Standard)

50%whey-50% casein (Alternative) DIETARY_SUPPLEMENT

see arm description

50%whey-50% casein (Alternative)

Micellar Casein Isolate- WPH DIETARY_SUPPLEMENT

see arm description

Micellar Casein Isolate- WPH

Micellar Casein Isolate - Na-caseinate DIETARY_SUPPLEMENT

see arm description

Micellar Casein Isolate - Na-caseinate

Micellar Casein Isolate DIETARY_SUPPLEMENT

see arm description

Micellar Casein Isolate

UHT milk DIETARY_SUPPLEMENT

see arm description

UHT milk

Recombined milk DIETARY_SUPPLEMENT

see arm description

Recombined milk

Recombined 50%whey milk DIETARY_SUPPLEMENT

see arm description

Recombined 50% whey milk

Ca-caseinate DIETARY_SUPPLEMENT

see arm description

Ca-caseinate

Milk protein isolate DIETARY_SUPPLEMENT

see arm description

Milk protein isolate

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• NIZO Food Research: lead
• FrieslandCampina: collaborator

Study Sites (1)

NIZO

Ede, Netherlands

Location

MeSH Terms

Interventions

Whey; Yogurt; Mutation

Intervention Hierarchy (Ancestors)

Milk; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Dairy Products; Food; Food and Beverages; Cultured Milk Products; Fermented Foods; Genetic Variation; Genetic Phenomena

Study Officials

• Alwine Kardinaal, PhD

  NIZO Food Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 2 groups of 10 subjects both receive a different set of 6 different dairy products. Each subject within a group will receive all treatments on the same day of the week with a 1 week washout period between treatments. Results of the two groups will be analyzed separately, and products will only be compared within the same group of subjects, treating the data as two independent studies.

Study Record Dates

• First Submitted: October 13, 2017
• First Posted: October 18, 2017
• Study Start: October 25, 2017
• Primary Completion: March 1, 2018
• Study Completion: May 2, 2018
• Last Updated: September 5, 2018

Record last verified: 2018-09

Locations

NL (1)