Postprandial Blood Amino Acid Response (PARROT-2)

September 3, 2018 updated by: NIZO Food Research

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
10

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
iAUC for postprandial individual plasma amino acids
Time Frame: Time Frame: 0-300 min after consumption
Time Frame: 0-300 min after consumption
Cmax for postprandial individual plasma amino acids
Time Frame: Time Frame: 0-300 min after consumption
Time Frame: 0-300 min after consumption

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
NIZO Food Research

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
FrieslandCampina

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 25, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 2, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 13, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 13, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 18, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 5, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 3, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Locations

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