Real-time Amino Acid Profiling

NCT ID: NCT03547362

Last Updated: 2018-07-11

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

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-30

Study Completion Date

2018-07-05

Brief Summary

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This study was designed to obtain information about the effect of new combinations of dairy proteins, in small servings with high protein concentrations, on postprandial amino acid kinetics in blood in an older population.

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

The study is designed as a randomized, single-blinded within-subject (cross-over) trial in which a group of 12 subjects receive 6 different dairy products.
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Casein

Single oral administration

Group Type EXPERIMENTAL

Casein

Intervention Type DIETARY_SUPPLEMENT

See arm description

Dairy protein blend 1

single oral administration

Group Type EXPERIMENTAL

Dairy protein blend 1

Intervention Type DIETARY_SUPPLEMENT

See arm description

Whey protein

Single oral administration

Group Type EXPERIMENTAL

Whey protein

Intervention Type DIETARY_SUPPLEMENT

See arm description

Dairy protein blend 2

Single oral administration

Group Type EXPERIMENTAL

Dairy protein blend 2

Intervention Type DIETARY_SUPPLEMENT

See arm description

Dairy protein blend 3

Single oral administration

Group Type EXPERIMENTAL

Dairy protein blend 3

Intervention Type DIETARY_SUPPLEMENT

See arm description

Dairy protein blend 4

Single oral administration

Group Type EXPERIMENTAL

Dairy protein blend 4

Intervention Type DIETARY_SUPPLEMENT

See arm description

Interventions

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Casein

See arm description

Intervention Type DIETARY_SUPPLEMENT

Dairy protein blend 1

See arm description

Intervention Type DIETARY_SUPPLEMENT

Whey protein

See arm description

Intervention Type DIETARY_SUPPLEMENT

Dairy protein blend 2

See arm description

Intervention Type DIETARY_SUPPLEMENT

Dairy protein blend 3

See arm description

Intervention Type DIETARY_SUPPLEMENT

Dairy protein blend 4

See arm description

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Age ≥65 and ≤80
* BMI ≥20 and ≤32 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 1 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 unexpected 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 to give up blood donation during the study
* Personnel of NIZO food research and FrieslandCampina, 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 or her health, like laboratory results and eventual adverse events to and from his general practitioner
Minimum Eligible Age

65 Years

Maximum Eligible Age

80 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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Melle van Schaik

Role: STUDY_DIRECTOR

NIZO Food Research

Locations

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NIZO Food Research

Ede, Gelderland, Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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NL65184.072.18

Identifier Type: -

Identifier Source: org_study_id

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