Postprandial Plasma Amino Acid Concentrations After Dairy Consumption

NCT ID: NCT02546141

Last Updated: 2016-01-12

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

2015-10-31

Study Completion Date

2015-12-31

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, in an elderly population and how this relates to gastric emptying rate and feelings of satiety.

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

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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skimmed milk (UHT)

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

Group Type ACTIVE_COMPARATOR

skimmed milk (UHT)

Intervention Type OTHER

skimmed milk (pasteurized)

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

Group Type ACTIVE_COMPARATOR

skimmed milk (pasteurized)

Intervention Type OTHER

skimmed yoghurt

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

Group Type ACTIVE_COMPARATOR

skimmed yoghurt

Intervention Type OTHER

full-fat milk (UHT)

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

Group Type ACTIVE_COMPARATOR

full-fat milk (UHT)

Intervention Type OTHER

non-homogenized full-fat milk (pasteurized)

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

Group Type ACTIVE_COMPARATOR

non-homogenized full-fat milk (pasteurized)

Intervention Type OTHER

full-fat cheese (semi-matured)

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

Group Type ACTIVE_COMPARATOR

full-fat cheese (semi-matured)

Intervention Type OTHER

whey protein

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

Group Type ACTIVE_COMPARATOR

whey protein

Intervention Type OTHER

micellar casein

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

Group Type ACTIVE_COMPARATOR

micellar casein

Intervention Type OTHER

Interventions

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skimmed milk (UHT)

Intervention Type OTHER

skimmed milk (pasteurized)

Intervention Type OTHER

skimmed yoghurt

Intervention Type OTHER

full-fat milk (UHT)

Intervention Type OTHER

non-homogenized full-fat milk (pasteurized)

Intervention Type OTHER

full-fat cheese (semi-matured)

Intervention Type OTHER

whey protein

Intervention Type OTHER

micellar casein

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Age over 60y
* BMI 21-30 kg/m2
* Non-smoking
* Healthy as assessed by the NIZO lifestyle and health questionnaire
* 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)

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
* A self-reported allergy or sensitivity to acetaminophen
* Alcohol consumption \> 28 units/week and 4/day
* Reported unexplained 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 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 health, like laboratory results and eventual adverse events to and from his general practitioner
Minimum Eligible Age

60 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

Locations

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NIZO food research

Ede, , Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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METC nr 15/18

Identifier Type: OTHER

Identifier Source: secondary_id

NL53912.081.15

Identifier Type: -

Identifier Source: org_study_id

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