Postprandial Blood Amino Acid Response

NCT ID: NCT03313791

Last Updated: 2018-09-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-25

Study Completion Date

2018-05-02

Brief Summary

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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

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Conditions

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Protein Digestion Kinetics

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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.
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Whey protein concentrate

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

Group Type EXPERIMENTAL

Whey protein concentrate

Intervention Type DIETARY_SUPPLEMENT

see arm description

Yoghurt

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

Group Type EXPERIMENTAL

Yoghurt

Intervention Type DIETARY_SUPPLEMENT

see arm description

50%whey-50% casein (Standard)

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

Group Type EXPERIMENTAL

50%whey-50% casein (Standard)

Intervention Type DIETARY_SUPPLEMENT

see arm description

50%whey-50% casein (Alternative)

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

Group Type EXPERIMENTAL

50%whey-50% casein (Alternative)

Intervention Type DIETARY_SUPPLEMENT

see arm description

Micellar Casein Isolate- WPH

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

Group Type EXPERIMENTAL

Micellar Casein Isolate- WPH

Intervention Type DIETARY_SUPPLEMENT

see arm description

Micellar Casein Isolate - Na-caseinate

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

Group Type EXPERIMENTAL

Micellar Casein Isolate - Na-caseinate

Intervention Type DIETARY_SUPPLEMENT

see arm description

Micellar Casein Isolate

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

Group Type EXPERIMENTAL

Micellar Casein Isolate

Intervention Type DIETARY_SUPPLEMENT

see arm description

UHT milk

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

Group Type EXPERIMENTAL

UHT milk

Intervention Type DIETARY_SUPPLEMENT

see arm description

Recombined milk

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

Group Type EXPERIMENTAL

Recombined milk

Intervention Type DIETARY_SUPPLEMENT

see arm description

Recombined 50% whey milk

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

Group Type EXPERIMENTAL

Recombined 50%whey milk

Intervention Type DIETARY_SUPPLEMENT

see arm description

Ca-caseinate

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

Group Type EXPERIMENTAL

Ca-caseinate

Intervention Type DIETARY_SUPPLEMENT

see arm description

Milk protein isolate

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

Group Type EXPERIMENTAL

Milk protein isolate

Intervention Type DIETARY_SUPPLEMENT

see arm description

Interventions

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Whey protein concentrate

see arm description

Intervention Type DIETARY_SUPPLEMENT

Yoghurt

see arm description

Intervention Type DIETARY_SUPPLEMENT

50%whey-50% casein (Standard)

see arm description

Intervention Type DIETARY_SUPPLEMENT

50%whey-50% casein (Alternative)

see arm description

Intervention Type DIETARY_SUPPLEMENT

Micellar Casein Isolate- WPH

see arm description

Intervention Type DIETARY_SUPPLEMENT

Micellar Casein Isolate - Na-caseinate

see arm description

Intervention Type DIETARY_SUPPLEMENT

Micellar Casein Isolate

see arm description

Intervention Type DIETARY_SUPPLEMENT

UHT milk

see arm description

Intervention Type DIETARY_SUPPLEMENT

Recombined milk

see arm description

Intervention Type DIETARY_SUPPLEMENT

Recombined 50%whey milk

see arm description

Intervention Type DIETARY_SUPPLEMENT

Ca-caseinate

see arm description

Intervention Type DIETARY_SUPPLEMENT

Milk protein isolate

see arm description

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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FrieslandCampina

INDUSTRY

Sponsor Role collaborator

NIZO Food Research

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alwine Kardinaal, PhD

Role: PRINCIPAL_INVESTIGATOR

NIZO Food Research

Locations

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NIZO

Ede, , Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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NIZO175

Identifier Type: OTHER

Identifier Source: secondary_id

NL62458.072.17

Identifier Type: -

Identifier Source: org_study_id

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